• No results found

Step 4: Training, Assimilation and Use

6. Conclusions

There were a total of 160 subjects recruited for this descriptive study comprising 80 type 2 diabetics (T2DM) and 80 non diabetic controls matched for age and sex (Tab. 1). The mean age for the T2DM subjects and apparently healthy controls were 60.9 ± 10.3 years (range 41 -79 years) and 61.0±10.3years (range 40- -79 years) respectively (p = 0.963). There was no significant difference in the ages of the two groups (Tab. 1).

There were 30 male and 50 female T2DM subjects as well as 34 male and 46 female control subjects recruited for this study (p=0.519). The age group with the highest frequency of occurrence was the seventh decade (60-69years) accounting for 36.3% of T2DM and 35% of control subjects while subjects in their forties (40-49years) constituted the age group with the least frequency of occurrence having 18.8% of T2DM and 20.0% of controls (Tab. 1).

The average weight of T2DM subjects and controls were 70.0±12.1years and 67.0±10.6 years respectively (p= 0.104). There was no significant difference in the BMI of the two groups (p=0.141) (Tab. 1).

Among the diabetics, 46.3% had normal BMI, 32.4% were overweight and 21.3% were obese.

Among the control subjects, 50.0%, 37.5% and 12.5% had BMI that was normal, overweight and obese respectively. There was no significant difference in the BMI distribution of the two groups (p=0.330) (Tab 1).

43

Tab. 1. A table showing subjects’ demographic characteristics and clinical parameters across the diabetics and the control subjects.

Variables

Study Groups

χ2 df p value

Diabetics Controls (n = 80) (n = 80)

*Age in years

Mean ± SD 60.9 ± 10.3 61.0 ± 10.3 158 0.963*

(Range) (41.0 - 79.0) (40.0 - 79.0)

n (%)

40 - 49 15 (18.8) 16 (20.0)

0.106 3 0.991

50 - 59 16 (20.0) 15 (18.8)

60 - 69 29 (36.3) 28 (35.0)

70 - 79 20 (25.0) 21 (26.3)

Gender n (%)

Male 30 (37.5) 34 (42.5)

0.417 1 0.519

Female 50 (62.5) 46 (57.5)

*Weight(Kg) 70.0 ± 12.1 67.0 ± 10.6 158 0.104*

*Height (m) 1.6 ± 0.1 1.6 ± 0.1 158 0.912*

*BMI (Kg/m2) 25.92 ± 4.50 25.15 ± 3.80 158 0.245*

Normal 37 (46.3) 40 (50.0)

2.217 2 0.330

Overweight 26 (32.4) 30 (37.5)

Obese 17 (21.3) 10 (12.5)

*

Independent samples t test;

df= degree of freedom BMI= body mass index Significant p<0.05

44

The median duration of diabetes (DM) was 42.0 months with a range of 1- 456 months.

Majority (53.8%) of the diabetic subjects were diagnosed less than 5years ago while 30% and 16.2% have been diagnosed of T2DM for 5-10years and >10years respectively (Tab 2).

One of the T2DM subjects had a history of right foot ulcer while two had previously had left foot ulcer (Tab. 2).

Regarding PN, 56/80 (70%) of the subjects had right foot PN while 24/80 (30%) did not have.

Also, 50/80 (62.5%) had left foot PN while 37.5% did not have PN in the left foot (Tab. 2).

Fasting blood glucose (FBG) was categorized as <5.6 mmol/l, 5.6-6.9 mmol/L and ≥7.0 mmol/L to represent good FBG, impaired FBG and poor FBG control respectively. Most (48.8%) of the diabetic subjects had poor FBG control, 31.3% had impaired FBG level while 20.0% had good FBG control (Fig. 11).

Glycated haemoglobin (HBA1c) level was categorized as good (<7.0%) and poor (≥7.0%) glycemic control. More T2DM subjects (63.8%) had HBA1c level ≥7.0% while 36.3% had HBA1C <7.0% (Fig. 11).

45

Tab. 2. A table showing clinical characteristics of Diabetic subjects (N = 80).

Variable n (%) Duration of DM (months)

Median (IQR) 42.0 (11.0 - 96.8)

Duration of DM

< 5years 43 (53.8)

5 - 10 years 24 (30.0)

> 10 years 13 (16.2)

History of right foot ulcer

Present 1 (1.3)

Absent 79 (98.8)

History of left foot ulcer

Present 2 (2.5)

Absent 78 (97.5)

Right foot peripheral neuropathy

Present 56 (70.0)

Absent 24 (30.0)

Left foot peripheral neuropathy

Present 50 (62.5)

Absent 30 (37.5)

IQR - Interquartile range DM= Diabetes Mellitus Significant p<0.05

46

Fig. 11: Bar charts showing the glycaemic levels as measured by FBG and HBA1c among the T2DM subjects.

16 (20.0 %)

25 (31.2%)

39 (48.8 %)

51 (63.8 %) 29 (36.2 %)

0 10 20 30 40 50 60

< 5.6 5.6 - 6.9 ≥ 7.0 Good (< 7.0 %) Poor (≥ 7.0 %)

Number of Subjec ts

FBG (mmol/L) HbA1c

47

Comparing Achilles tendon and plantar fascia thicknesses between T2DM and control subjects as well as comparison between right and left limbs.

The mean thickness of right Achilles tendon (AT) among T2DM was 5.78±0.76mm while the mean thickness of right AT among control subjects was 4.57 ± 0.57mm. The right AT was significantly thicker in diabetic subjects than the control subjects (p< 0.001) (Tab. 3).

The average thickness of the left Achilles tendon among T2DM and control subjects 5.72±

0.86mm and 4.54±0.56mm respectively. The left AT was significantly thicker among T2DM subjects than control subjects (p<0.001) (Tab. 3).

The mean right PF thickness of T2DM subjects was 1.93 ± 0.36mm while that of control subjects was 1.44±0.20mm (p<0.001). Similarly, the average thickness of the left PF of T2DM and control subjects measured 1.91±0.41mm and 1.45±0.20mm respectively (p<0.001). There were significant differences in the plantar fascia thickness of right and left feet of T2DM subjects compared with those of control subjects (both p<0.05) (Tab. 3).

The average thickness of the AT on the right and left limbs of T2DM did not significantly differ (p=0.256). Also, the control subjects had no significant difference in the thickness of AT between the right and left feet (p=0.224) (Tab. 4).

The mean PF thickness of the right and left limb measured 1.93 ± 0.36mm and 1.91±0.41mm respectively among T2DM subjects (p=0.562) (Tab. 4). The control subjects had a mean PF thickness for the right and left feet of 1.44 ± 0.20mm and 1.45 ± 0.20mm respectively (p=0.906) (Tab. 4).

48

Tab. 3: A table comparing the means of the thicknesses of the Achilles tendon and plantar fascia of diabetics with that of control subjects.

Variables Diabetics Controls

t df p value (n = 80) (n = 80)

Right Achilles tendon thickness (mm) 5.78 ± 0.76 4.57 ± 0.57 11.400 158 < 0.001

Left Achilles tendon thickness (mm) 5.72 ± 0.86 4.54 ± 0.56 10.274 158 < 0.001

Right plantar fascia thickness (mm) 1.93 ± 0.36 1.44 ± 0.20 10.453 158 < 0.001

Left plantar fascia thickness (mm) 1.91 ± 0.41 1.45 ± 0.20 9.016 158 < 0.001 t - paired-samples t test

Significant p<0.05

49

Tab. 4: A table showing Paired comparison of AT and PF measurements between the right and left feet

Variables Mean ± SD

t p value

Right Left

Achilles tendon thickness (mm)

Diabetics 5.78 ± 0.76 5.72 ± 0.86 1.143 0.256

Controls 4.57 ± 0.57 4.54 ± 0.56 1.226 0.224

Planter fascia thickness (mm)

Diabetics 1.93 ± 0.36 1.91 ± 0.41 0.583 0.562

Controls 1.44 ± 0.20 1.45 ± 0.20 -0.118 0.906

t - paired-samples t test Significant p<0.05

50

Comparison of the thicknesses of AT and PF of male and female diabetics with their corresponding sex matched control subjects.

The mean thickness of right AT of male diabetics and male control subjects measured 6.22 ± 0.76 mm and 4.49 ± 0.61 mm respectively (p<0.001) (Tab. 6). The left AT was also significantly thicker among diabetics than their sex matched control subjects (6.12±0.98mm vs 4.42±0.58mm, p<0.001). Also, the PF thickness of the right and left feet of male diabetics were significantly thicker than the male control subjects (p<0.001) (Tab. 5).

Similarly, female diabetic subjects had significantly thicker right and left AT than their corresponding control subjects (p<0.001 bilaterally). Also, the average thickness of the plantar fascia in both limbs were significantly thicker in female T2DM than female control subjects (p< 0.001 bilaterally) (Tab. 5).

51

Tab. 5: A table showing the comparison between male subjects as well as female subjects in the two study groups

Variables

Male DM (n = 30)

Male controls

(n = 34) t p-value

Age (years) 64.6 ± 9.8 64.6 ± 9.9 0.013 0.990

BMI (Kg/m2) 24.89 ± 3.62 23.38 ± 2.48 1.889 0.065

Right AT diameter (mm) 6.22 ± 0.76 4.49 ± 0.61 9.693 < 0.001 Left AT diameter (mm) 6.12 ± 0.98 4.42 ± 0.58 8.147 < 0.001 Right PF thickness (mm) 1.94 ± 0.27 1.40 ± 0.21 8.557 < 0.001 Left PF thickness (mm) 1.90 ± 0.30 1.40 ± 0.23 7.280 < 0.001

Female DM (n = 50)

Female Controls (n = 46)

Age (years) 58.7 ± 10.0 58.8 ± 10.0 -0.070 0.945

BMI (Kg/m2) 26.54 ± 4.89 26.22 ± 4.07 0.360 0.720

Right AT diameter (mm) 5.51 ± 0.63 4.62 ± 0.54 7.644 < 0.001 Left AT diameter (mm) 5.48 ± 0.68 4.62 ± 0.53 7.058 < 0.001 Right PF thickness (mm) 1.92 ± 0.41 1.47 ± 0.19 7.080 < 0.001 Left PF thickness (mm) 1.92 ± 0.47 1.47 ± 0.19 6.199 < 0.001 Significant p<0.05

t- paired T- test

52

Comparison of AT and PF thicknesses of diabetics with the length of diagnosis of DM.

The duration of diagnosis of T2DM was grouped into < 5 years, 5-10 years and >10 years. The mean right AT thickness among T2DM who were diagnosed < 5 years ago was 5.63 ± 0.68mm.

Among those diagnosed for 5-10 years, the average right AT measured 5.74 ± 0.75mm while it measured 6.35±0.84mm in those with >10 years duration of T2DM diagnosis (p=0.009) (Tab. 6). Likewise, the left AT thickness among those diagnosed < 5 years, 5 - 10 years and

>10 years were 5.45 ± 0.75mm, 5.91 ± 0.94mm and 6.26 ± 0.84mm respectively (p=0.004) (Tab. 6).

The right PF measured 1.87 ± 0.32mm, 2.03 ± 0.47mm and 1.92 ± 0.23mm amongst T2DM subjects with DM duration of < 5years, 5-10 years and >10 years respectively. There was no significant difference between them (p=0.241) (Tab. 6).

Also, the left PF measured 1.85 ± 0.35mm, 1.99 ± 0.53mm and 1.94 ± 0.32mm among diabetic subjects with DM duration of <5 years, 5-10 years and >10 years respectively (p=0.409) (Tab.

6).

Scheffe post-hoc analysis was done for the AT thickness to assess for intergroup differences among those diagnosed with T2DM for <5 years, 5-10 years and >10 years (Tab. 6). Significant difference in the thickness of AT was seen only between those diagnosed <5years ago compared with those >10 years duration of DM diagnosis on the right (p= 0.010) and left (p = 0.008) feet (Tab. 6). Other intergroup comparisons only revealed an increase in AT thickness bilaterally as the duration of T2DM diagnosis increased, the differences were not statistically significant (p> 0.05) (Tab. 6).

53

Tab. 6. A table showing the comparison between the means of AT and PF thicknesses with duration of DM, and the Scheffe post-hoc analysis.

Duration of DM

Right AT (mm)

Left AT (mm)

Right PF (mm)

Left PF (mm)

< 5years 5.63 ± 0.68 5.45 ± 0.72 1.87 ± 0.32 1.85 ± 0.35 5 - 10 years 5.74 ± 0.75 5.91 ± 0.94 2.03 ± 0.47 1.99 ± 0.53

> 10 years 6.35 ± 0.82 6.26 ± 0.84 1.92 ± 0.24 1.94 ± 0.32

F 4.968 6.036 1.450 0.905

p value 0.009 0.004 0.241 0.409

Scheffe Post-hoc analysis for intergroup differences p value p value

< 5years vs. 5 - 10 years 0.838 0.087

< 5years vs. > 10 years 0.010 0.008

5 - 10 years vs. > 10 years 0.057 0.450

F –one-way ANOVA to compare the means Significant p <0.05

54

Comparing the effect of BMI on the thicknesses of AT and PF in T2DM and Control subjects.

Among T2DM subjects, the mean thickness of the right AT in those with normal BMI, overweight and obese BMI were 5.67 ± 0.72 mm, 5.78 ± 0.67 and 5.82 ± 0.84mm respectively (p= 0.792) (Tab. 7). Also, the left AT thickness did not significantly differ across the three BMI groups (p= 0.817) (Tab. 7). Although, the obese subjects had thicker mean AT on both feet than the overweight group, who also had thicker AT than those with normal BMI, the difference was not statistically significant.

In T2DM subjects, the PF thickness on the right foot measured 1.87±0.35 mm, 1.93±0.37mm and 2.01±0.37mm among those having normal BMI, overweight BMI and obese BMI respectively (p=0.488) (Tab. 7). Similarly, the PF thickness of the left foot was highest amongst the obese (1.82±0.22mm) and lowest among those with normal BMI (1.40±0.20mm); the difference was not statistically significant (p=0.387) (Tab. 7).

Among the control subjects, there was statistically significant increase in the AT of both feet with increasing BMI (Rt. AT p=0.029; Lt. AT p=0.015) (Tab. 8). Scheffe post-hoc analysis to evaluate for intergroup differences revealed that, only the difference between the AT thickness of those with normal BMI and the obese subjects was statistically significant (Rt. AT p =0.041, Lt. AT p =0.024) (Tab. 8). The differences in the AT among other groups were not statistically significant in both feet (p>0.05). A trend of increased PF thickness was seen in both limbs with increase in BMI from normal to obese among control subjects (Tab. 8). However, the increase was not statistically significant (p>0.05 bilaterally).

AT of both limbs of control subjects had significant correlation with BMI compared with diabetic subjects (Fig 12 & 13).

55

Tab. 7. A table showing the differences in AT and PF thicknesses by BMI groups among diabetic subjects

BMI Right AT (mm) Left AT (mm) Right PF (mm) Left PF (mm) Normal 5.67 ± 0.72 5.65 ± 0.76 1.87 ± 0.35 1.82 ± 0.32 Overweight 5.78 ± 0.67 5.67 ± 0.90 1.93 ± 0.37 1.86 ± 0.32 Obese 5.82 ± 0.84 5.78 ± 0.89 2.01 ± 0.37 1.96 ± 0.42

F 0.235 0.202 0.725 0.961

p value 0.792 0.817 0.488 0.387

F- One-way ANOVA Significant p <0.05

56

Tab. 8. A table showing the differences in AT and PF thicknesses by BMI groups among control subjects

BMI

Right AT (mm)

Left AT (mm)

Right PF (mm)

Left PF (mm) Normal 4.41 ± 0.53 4.39 ± 0.53 1.41 ± 0.19 1.40 ± 0.20 Overweight 4.67 ± 0.55 4.62 ± 0.52 1.46 ± 0.20 1.46 ± 0.18 Obese 4.88 ± 0.63 4.92 ± 0.62 1.53 ± 0.22 1.56 ± 0.25

F 3.706 4.437 1.827 2.662

p value 0.029 0.015 0.168 0.076

Scheffe Post-hoc analysis for intergroup differences p value p value

Normal vs. Overweight 0.161 0.211

Normal vs. Obese 0.041 0.024

Overweight vs. Obese 0.583 0.312

F -One-way ANOVA to compare the means Significant p <0.05

57

Fig.12: Scatterplot showing positive correlation between Right Achilles Tendon (AT) thickness and Body Mass Index (BMI) among Controls (r = 0.340, p = 0.002) compared to a negligible relationship obtained among Diabetics (r = 0.008, p = 0.947).

58

Fig.13: Scatterplot showing positive correlation between Left Achilles Tendon (AT) thickness and Body Mass Index (BMI) among Controls (r = 0.356, p = 0.001) compared to a negligible relationship observed among Diabetics (r = 0.030, p = 0.788).

59

Determination of the effects of peripheral neuropathy (PN) on the thicknesses of AT and PF.

Three groups comprising diabetics with peripheral neuropathy (T2DM+ PN), diabetics without peripheral neuropathy (T2DM- PN) and control subjects were compared based on the mean thickness of their AT and PF in both feet. The mean thickness of the right AT was highest among diabetics with PN which was 6.08±0.65mm, that of diabetics without PN was 5.08±0.48mm while the mean right AT thickness of control subjects was the least with a value of 4.57 ± 0.57mm (p<0.001) (Tab. 9). Similarly, the mean right plantar fascia thickness in those with right foot PN was compared with that of those without PN and also with control subjects.

The mean right plantar fascia thickness was highest among the DM with PN group (1.95±0.35mm) followed by diabetics without PN (1.88 ± 0.39mm) and lastly by that of controls which was 1.44 ± 0.20mm (p< 0.001) (Tab. 9).

In like manner, those with left foot PN had thicker average left AT thickness than other diabetics without PN with the control group having the least value of mean left AT thickness (p< 0.001) (Tab. 9). Also, the average left PF thickness was highest in T2DM with PN (1.97±0.40mm) than T2DM without PN (1.81 ± 0.43mm) who also had greater value than the control group (1.45 ± 0.20mm). The difference in the left PF thickness across the three groups was statistically significant (p< 0.001) (Tab. 9).

Scheffe post-hoc evaluation to further establish the statistical significance of the intergroup differences revealed that the AT thickness of both feet was significantly different between the groups (p< 0.001) (Tab. 10). However, intergroup evaluation of the right PF thickness showed that there is no significant difference between the means of right PF thickness of T2DM with PN and T2DM without PN (Tab. 10). Significant difference only existed when the mean values of T2DM with and without PN were independently compared with the mean

60

Tab. 9. A table showing the differences in AT and PF thicknesses between DM subjects with and without peripheral neuropathy, and control subjects.

Variables

DM with PN DM without PN Controls

F p value

Right foot PN (n = 56) (n = 24) (n = 80)

Right AT diameter (mm) 6.08 ± 0.65 5.08 ± 0.48 4.57 ± 0.57 108.487 < 0.001

Right PF thickness (mm) 1.95 ± 0.35 1.88 ± 0.39 1.44 ± 0.20 55.217 < 0.001

Left foot PN (n = 50) (n = 30) (n = 80)

Left AT diameter (mm) 6.15 ± 0.66 5.00 ± 0.65 4.54 ± 0.56 107.528 < 0.001

Left PF thickness (mm) 1.97 ± 0.40 1.81 ± 0.43 1.45 ± 0.20 43.808 < 0.001 PN- peripheral neuropathy

Significant p <0.05

61 Significant p < 0.05

Tab. 10. A table showing Scheffe Post-hoc analysis for intergroup differences amongst DM subjects with and without peripheral, and control subjects.

Variables p value

Right AT

DM with PN vs. DM without PN < 0.001 DM with PN vs. Control < 0.001

DM without PN vs. Control 0.001

Right PF

DM with PN vs. DM without PN 0.577 DM with PN vs. Control < 0.001 DM without PN vs. Control < 0.001 Left AT

DM with PN vs. DM without PN < 0.001 DM with PN vs. Control < 0.001

DM without PN vs. Control 0.002

Left PF

DM with PN vs. DM without PN 0.108 DM with PN vs. Control < 0.001

DM without PN vs. Control < 0.001

62

right PF thickness of the control group (p< 0.001) (Tab. 10). Equally, the mean of left PF thickness did not significantly differ between T2DM with and without PN. The significant difference existed when each of the groups were separately compared with the mean left PF thickness of the control group (Tab. 10).

Differences in AT and PF mean thicknesses among various age groups of control subjects.

The right AT was thickest in the 50 – 59 years age group and least in thickness amongst those in their 5th decade (40 - 49years) while the left was thickest in those in their 50s, it was least among those in their 60s (Tab. 11). The difference in the AT thickness of both feet did not significantly vary across different age groups (both p>0.05) (Tab. 11).

The PF of both feet was thickest among those aged 50-59years and least among those aged 70-79years. The difference in the PF of both limbs did not vary significantly within the age groups (p> 0.05) (Tab. 11).

Amongst T2DM, the thickness of both AT was highest in those that were 70-79 years old while those in their 40s had the least value of AT thickness bilaterally. The difference in AT thickness was statistically significant in both feet (p>0.05) (Tab. 12). Scheffe post-hoc analysis to evaluate the actual intergroup differences showed that significant difference actually existed between those in their 40s and those in their 70s in both left (p = 0.048) and right (p = 0.001) feet (Tab. 12). Also, significant difference was shown only in the right limb between those aged 40-49 years and 60-69 years (p = 0.033). Other intergroup differences were not significant (p>0.05) (Tab. 12).

63 Significant p <0.05

F- one-way ANOVA

Tab. 11. A table showing the differences in AT and PF mean thicknesses among various age groups of control subjects.

Age group (yrs.) Right AT (mm) Left AT (mm) Right PF (mm) Left PF (mm) 40 - 49 4.48 ± 0.57 4.56 ± 0.59 1.41 ± 0.18 1.41 ± 0.18 50 - 59 4.79 ± 0.54 4.69 ± 0.53 1.51 ± 0.19 1.53 ± 0.22 60 - 69 4.54 ± 0.47 4.48 ± 0.48 1.48 ± 0.23 1.46 ± 0.23 70 - 79 4.51 ± 0.70 4.50 ± 0.65 1.37 ± 0.16 1.38 ± 0.17

F 0.944 0.518 2.081 1.891

p value 0.424 0.671 0.110 0.138

64

Tab. 12. A table showing the comparison of the mean thicknesses of AT and PF with Age groups of DM subjects as well as Scheffe post-hoc analysis for intergroup differences Age group (yrs)

Right AT (mm)

Left AT (mm)

Right PF (mm)

Left PF (mm) 40 - 49 5.15 ± 0.57 5.19 ± 0.65 1.81 ± 0.37 1.73 ± 0.32 50 - 59 5.84 ± 0.74 5.88 ± 0.85 2.09 ± 0.50 2.00 ± 0.46 60 - 69 5.82 ± 0.68 5.72 ± 0.77 1.90 ± 0.31 1.87 ± 0.31 70 - 79 6.15 ± 0.76 5.98 ± 1.00 1.92 ± 0.27 2.03 ± 0.52

F 6.046 2.877 1.696 1.917

P value 0.001 0.042 0.175 0.134

Scheffe Post-hoc analysis for intergroup differences p value p value 40 - 49 yr vs. 50 - 59 yr 0.062 0.159 40 - 49 yr vs. 60 - 69 yr 0.033 0.275 40 - 49 yr vs. 70 - 79 yr 0.001 0.048 50 - 59 yr vs. 60 - 69 yr 1.000 0.939 50 - 59 yr vs. 70 - 79 yr 0.630 0.988

60 - 69 yr vs. 70 - 79 yr 0.457 0.756

F means one-way ANOVA to compare the means Significant p <0.05

65

Comparing AT and PF thickness with the levels of glycaemic control of T2DM subjects.

The HBA1c level was grouped into good glycemic control (HBA1c <7%) and poor glycemic control (HBA1c ≥7%). Generally, it was observed that the mean thickness of the AT of both feet was thicker in those with poor glycemic control (RT= 5.83±0.78mm, LT= 5.75±0.93mm) than in those having good glycemic level (RT= 5.68±0.72mm, LT= 5.65±0.73) (both p>0.05) (Tab. 13).

So also, the mean PF thicknesses in both feet were greater in those with poor glycemic control compared with those with good glycemic levels. However, the difference was neither statistically significant on the right PF (p =0.487) nor the left PF (p =0.555) (Tab. 13).

The Fasting blood Glucose (FBG) level was categorized as good (< 5.6mmol/l), impaired (5.6-6.9mmol/l) and poor (≥7.0mmol/l) FBG levels, and the mean thickness of AT and PF were compared across various levels of FBG. Those with impaired FBG level had the highest mean thickness of AT on the right foot (5.87±0.69mm) as well as on the left foot (5.78±0.71mm) (Tab. 13). The least mean thickness of AT in both feet was observed in those with FBG < 5.6 mmol/l (right AT =5.56 ±0.73, left AT= 5.58 ± 0.70mm). The differences in the means of AT of both feet is not statistically significant across the various FBG levels (both p >0.05) (Tab.

13).

So also, mean thickness of the plantar fascia was highest in the group with impaired FBG level on the right foot (1.96 ± 0.35mm) and the left foot (1.97 ±0.50mm). Mean PF thickness was lowest in the right foot among those with good FBG level (1.89 ±0.31mm) while on the left PF, the lowest mean thickness was among those with poor FBG level (1.86 ±0.33mm).

However, no statistically significant difference was found in the PF thickness of both limbs based on FBG levels (p>0.05) (Tab. 13).

66

Tab. 13. A table showing the comparison of AT and PF thicknesses with level of glycaemic control among diabetics

Glycaemic control

Right AT (mm)

Left AT (mm)

Right PF

(mm) Left PF (mm) HbA1c

Good (HbA1c < 7.0%) 5.68 ± 0.72 5.65 ± 0.73 1.89 ± 0.28 1.87 ± 0.43 Poor (HbA1c ≥ 7.0%) 5.83 ± 0.78 5.75 ± 0.93 1.95 ± 0.41 1.93 ± 0.40

t -0.840 -0.515 -0.699 -0.593

p value 0.403 0.608 0.487 0.555

FBG

< 5.6 mmol/L 5.56 ± 0.73 5.58 ± 0.70 1.89 ± 0.31 1.93 ± 0.45 5.6 - 6.9 mmol/L 5.87 ± 0.69 5.78 ± 0.71 1.96 ± 0.35 1.97 ± 0.50

≥ 7.0 mmol/L 5.81 ± 0.81 5.74 ± 1.01 1.92 ± 0.40 1.86 ± 0.33

F 0.891 0.264 0.225 0.532

p value 0.415 0.769 0.799 0.589

F- One way ANOVA Significant p<0.05

HBA1c- glycated haemoglobin FBG- fasting blood glucose

67

Degenerative changes in AT of T2DM compared with that of control subjects.

More T2DM subjects had Right AT disorganized fibres (Fig. 7) which was 43/80 (53.8%) compared with 14(17.5%) of control subjects (p< 0.001) (Tab. 14). Also on the left foot, a significantly greater number of T2DM subjects had disorganized AT fibres than control subjects (51.3% vs. 15.0%, p< 0.001) (Tab. 14).

More T2DM had AT hypoechoic foci (Fig. 8) on both feet than controls. 20% of T2DM had hypoechoic foci in their right AT while only 5% of control subjects had this feature (p =0.004).

Also in the left AT, 18.8% of T2DM subjects had hypoechoic foci compared with 7.5% of control subjects (p =0.035) (Tab. 14).

The difference in the occurrence of calcific foci (Fig. 9) in the AT of both feet of T2DM subjects and those of control subjects was not statistically significant (both p>0.05) (Tab. 14).

The presence of either of calcific foci, disorganized fibres and/or hypoechoic foci in the right AT was compared between T2DM and control subjects, the prevalence was significantly higher among diabetics than control subjects (55.0% vs. 18.8%, p< 0.001). Correspondingly in the left AT, 52.5% of T2DM had one or more of the degenerative features compared with 18.8% of control subjects (p< 0.001) (Tab. 14).

68

Tab. 14. A table showing comparison of the degenerative changes in the AT of T2DM and control subjects.

Variables

Study Group, n (%)

χ2 df p value Diabetics Controls

(n = 80) (n = 80)

Right AT calcifications

Present 4 (5.0) 0 (0.0)

0.120*

Absent 76 (95.0) 80 (100.0)

Left AT calcifications

Present 5 (6.3) 2 (2.5)

0.443*

Absent 75 (93.8) 78 (97.5)

Right AT disorganized fibres

Present 43 (53.8) 14 (17.5)

22.919 1 < 0.001

Absent 37 (46.3) 66 (82.5)

Left AT disorganized fibres

Present 41 (51.3) 12 (15.0)

23.728 1 < 0.001

Absent 39 (48.8) 68 (85.0)

Right AT hypoechoic foci

Present 16 (20.0) 4 (5.0)

8.229 1 0.004

Absent 64 (80.0) 76 (95.0)

Left AT hypoechoic foci

Present 15 (18.8) 6 (7.5)

4.440 1 0.035

Absent 65 (81.2) 74 (92.5)

Right AT calcification, disorganized fibres or hypoechoic foci

Present 44 (55.0) 15 (18.8)

22.581 1 < 0.001

Absent 36 (45.0) 65 (81.2)

Left AT calcification, disorganized fibres or hypoechoic foci

Present 42 (52.5) 15 (18.8)

19.867 1 < 0.001

Absent 38 (47.5) 65 (81.2)

* Fisher's exact test*

df – degree of freedom significant p< 0.05

69

Comparison of various degenerative changes with the demographic, clinical and laboratory characteristics of T2DM subjects.

Features of Disorganized AT Fibres:

The mean age of those with disorganized AT fibres was significantly greater than the mean age of those without disorganized fibres (p =0.003) (Tab. 15). Across various age groups, a higher fraction of those in their 70s had disorganized fibres in either of the AT while the prevalence among those in their 40s was the least (p =0.006) (Tab. 16). On the basis of gender, 24/30 (80%) males had disorganized AT fibres while 24/50 (48.0%) females had features of tendoachilles disorganization (p=0.005) (Tab. 16). The prevalence amid different BMI groups did not significantly differ (p>0.05) although higher prevalence was seen among the obese which was 11/17 (64.7%) compared with normal BMI group 19/37 (51.4%) (Tab. 16).

The prevalence rates of disorganized AT fibres amongst DM subjects with length of diagnosis of <5years, 5-10years and >10years were 46.5%, 70.8%, 84.6% respectively (p=0.021) (Tab.

16). A higher proportion of T2DM subjects with PN had disorganized fibres which was 41/57 (71.9%) compared with the prevalence among diabetics without PN 7/21 (30.4%) (p=0.001) (Tab. 16).

Mean FBG level was higher among those with disorganized AT fibres which was 8.7±5.4mmo/l compared with those with absence of the feature which was 7.4±2.4mmol/l (p=0.163) (Tab. 15). Similarly, the prevalence did not significantly differ among various FBG levels vis-à-vis good, impaired and poor FBG (p= 0.971) (Tab.17). Also, the prevalence of disorganized AT fibres did not significantly differ among those with HBA1c ≥7.0% and HBA1c <7.0% (p=0.506) (Tab. 16).

Tab. 15. A table showing the association between the degenerative changes with characteristics of Diabetic subjects

70

Variables Degeneration

t p value

Present Absent

AT disorganized fibres

Age (Mean ± SD) (years) 63.8 ± 8.7 56.6 ± 11.0 3.132 0.003 BMI (Mean ± SD) (Kg/m2) 26.44 ± 4.36 25.14 ± 4.67 1.272 0.207 FBG (Mean ± SD) (mmol/L) 8.7 ± 5.4 7.4 ± 2.4 1.409 0.163 HbA1c (Mean ± SD) (%) 8.7 ± 2.8 8.2 ± 2.4 0.853 0.396 DM duration

Median (IQR)months 67.0 (16.0 - 116.8) 24.0 (6.0 - 61.8) -2.294 0.022**

AT hypoechoic foci

Age (Mean ± SD) (years) 65.9 ± 7.2 59.7 ± 10.6 2.773 0.009 BMI (Mean ± SD) (Kg/m2) 25.86 ± 4.72 25.94 ± 4.49 -0.068 0.946 FBG (Mean ± SD) (mmol/L) 9.7 ± 7.3 7.8 ± 3.4 1.004 0.330 HbA1c (Mean ± SD) (%) 9.5 ± 3.0 8.3 ± 2.5 1.757 0.083 DM duration

Median (IQR)months 64.5 (28.5 - 103.0) 37.5 (8.8 - 96.8) -0.848 0.396**

AT calcifications

Age (Mean ± SD) (years) 65.5 ± 7.2 60.6 ± 10.5 1.134 0.260 BMI (Mean ± SD) (Kg/m2) 27.87 ± 5.52 25.77 ± 4.42 1.100 0.275 FBG (Mean ± SD) (mmol/L) 7.9 ± 3.0 8.2 ± 4.6 -0.144 0.886 HbA1c (Mean ± SD) (%) 9.3 ± 3.8 8.5 ± 2.5 0.508 0.632 DM duration

Median (IQR)months 65.0 (21.5 - 206.3) 38.5 (7.5 - 96.3) -1.042 0.298**

AT degenerative changes*

Age (Mean ± SD) (years) 63.8 ± 8.7 56.5 ± 11.2 3.094 0.003 BMI (Mean ± SD) (Kg/m2) 26.41 ± 4.32 25.15 ± 4.74 1.219 0.227 FBG (Mean ± SD) (mmol/L) 8.8 ± 5.4 7.3 ± 2.2 1.740 0.086 HbA1c (Mean ± SD) (%) 8.8 ± 2.8 8.0 ± 2.2 1.395 0.167 DM duration

Median (IQR)months 66.0 (17.0 - 116.5) 23.0 (6.0 - 62.0) -2.218 0.027**

* Any of AT calcification, disorganized fibres or hypoechoic foci

** Mann-Whitney U test Significant p<0.05

71

Tab. 16 A table showing comparison of disorganized fibres of AT with characteristics of Diabetics

Variables

Diabetics

χ2 df p value AT disorganized

fibres

Present Absent Total

Age (years)

40 - 49 3 (20.0) 12 (80.0) 16(100)

12.315 3 0.006

50 - 59 11 (68.8) 5 (31.3) 16(100)

60 - 69 20 (69.0) 9 (31.0) 29(100)

70 - 79 14 (70.0) 6 (30.0) 20(100)

Gender

Male 24 (80.0) 6 (20.0) 30 (100)

8.000 1 0.005

Female 24 (48.0) 26 (52.0) 50 (100)

BMI (Kg/m2)

Normal 19 (51.4) 18 (48.6) 37 (100)

2.233 2 0.327

Overweight 18 (69.2) 8 (30.8) 26 (100)

Obese 11 (64.7) 6 (35.3) 17 (100)

DM Duration (months)

< 5years 20 (46.5) 23 (53.5) 43 (100)

7.715 2 0.021 5 - 10 years 17 (70.8) 7 (29.2) 24 (100)

> 10 years 11 (84.6) 2 (15.4) 13 (100)

Any peripheral neuropathy

Present 41 (71.9) 16 (28.1) 57 (100)

11.757 1 0.001

Absent 7 (30.4) 16 (69.6) 23 (100)

FBG

< 5.6 (mmol/L) 10 (62.5) 6 (37.5) 16 (100)

0.059 2 0.971 5.6 - 6.9 (mmol/L) 15 (60.0) 10 (40.0) 25 (100)

≥ 7.0 (mmol/L) 23 (59.0) 16 (41.0) 39 (100)

HBA1c

Poor (HbA1c ≥ 7.0%) 32 (62.7) 19 (37.3) 51 (100)

0.442 1 0.506 Good (HbA1c < 7.0%) 16 (55.2) 13 (44.8) 29 (100)

Significant p<0.05

FBG- fasting blood glucose HBA1c- glycated haemoglobin BMI- body mass index

72 Features of AT hypoechoic foci:

The mean age of those with and without hypoechoic foci in either of their AT were 65.9±7.2years and 59.7±10.9years respectively (p=0.009) (Tab. 15). The presence of hypoechoic foci showed a trend of increasing prevalence with increasing age from 0% among 40-49 years age group to 9/29 (31.0%) in those aged 60-69years. Those aged 70-79 years had a prevalence of 5/20 (25.0%) (p=0.060) (Tab. 17). There was no significant difference in the prevalence of AT hypoechoic foci with gender (p= 0.083). So also, the rate of occurrence of AT hypoechoic foci among different BMI groups did not significantly differ (p=0.466) (Tab.

17).

The duration of DM diagnosis showed no significant influence on the prevalence of tendoachilles hypoechoic foci among those with length of duration of < 5years (6/43; 14%), 5-10years (7/24; 29.2%) and >5-10years (3/13; 23.1%) (p=0.314) (Tab. 17). The rate of occurrence of hypoechoic foci was significantly higher among those with PN who had 15/42 (26.3%) compared to those without PN 1/23 (4.3%) (p=0.031) (Tab. 17).

The mean FBG was higher among those with AT hypoechoic foci, which was 9.7±7.3mmol/l while those without it had 7.8±3.4mmol/l (p= 0.330) (Tab.15). The prevalence of hypoechoic foci did not significantly vary among those with good, impaired and poor FBG levels (p=0.776) (Tab. 17). So also, mean HBA1c of T2DM with and without AT hypoechoic foci were 9.5±3.0% and 8.3±2.5% respectively (p=0.083). Among those with poor HBA1c level, 11/51 (21.6%) had hypoechoic foci while it was found in 5/29 (17.2%) of those with good HBA1c level (p=0.642) (Tab. 17).

73

Tab. 17. A table showing comparison of hypoechoic foci of AT with characteristics of Diabetics

Variables

Diabetics

χ2 df p value AT hypoechoic foci

Present Absent Total

Age (years)

40 - 49 0 (0.0) 15 (100.0) 15 (100.0)

0.060*

50 - 59 2 (12.5) 14 (87.5) 16 (100.0)

60 - 69 9 (31.0) 20 (69.0) 29 (100.0)

70 - 79 5 (25.0) 15 (75.0) 20 (100.0)

Gender

Male 9 (30.0) 21 (70.0) 30 (100.0)

3.000 1 0.083

Female 7 (14.0) 43 (86.0) 50 (100.0)

BMI (Kg/m2)

Normal 7 (18.9) 30 (81.1) 37 (100.0)

1.526 2 0.466

Overweight 7 (26.9) 19 (73.1) 26 (100.0)

Obese 2 (11.8) 15 (88.2) 17 (100.0)

Duration of DM (months)

< 5years 6 (14.0) 37 (86.0) 43 (100.0)

2.320 1 0.314 5 - 10 years 7 (29.2) 17 (70.8) 24 (100.0)

> 10 years 3 (23.1) 10 (76.9) 13 (100.0) Any peripheral neuropathy

Present 15 (26.3) 42 (73.7) 57 (100.0)

0.031*

Absent 1 (4.3) 22 (95.7) 23 (100.0)

FBS

< 5.6 (mmol/L) 4 (25.0) 12 (75.0) 16 (100.0)

0.506 2 0.776 5.6 - 6.9 (mmol/L) 4 (16.0) 21 (84.0) 25 (100.0)

≥ 7.0 (mmol/L) 8 (20.5) 31 (79.5) 39 (100.0) Glycaemic control

Poor (HbA1c ≥ 7.0%) 11 (21.6) 40 (78.4) 51 (100.0)

0.216 1 0.642 Good (HbA1c < 7.0%) 5 (17.2) 24 (82.8) 29 (100.0)

* Fisher's exact test Significant p<0.05

FBG- fasting blood glucose BMI- body mass index

74 Calcific foci in AT:

There was no significant difference in the prevalence of AT calcifications among T2DM subjects based on age, gender and body mass index (p> 0.05) (Tab. 18). The prevalence of AT calcifications marginally increased from 4.7% among those < 5years DM duration, 8.3%

among those with 5-10 years length of disease, to 15.4% among those with >10years disease duration. This observed differences were not statistically significant (p= 0.295) (Tab. 18).

Among those with peripheral neuropathy, 5/57 (8.8%) had AT calcifications while this was observed in only 1/23 (4.3%) of those without peripheral neuropathy (p= 0.667). So also, the rate of occurrence of AT calcifications did not significantly differ based on the level of glycemic control as measured by FBG and HBA1c (both p>0.05) (Tab. 18).

Comparison of AT degenerative changes with various Age, gender and BMI of control subjects

Among the control subjects, the prevalence of disorganized AT fibres and AT hypoechoic foci significantly differ across various age groups (both p<0.05) (Tab. 19). AT Calcifications showed no significant difference across various age groups (p>0.05) among the control subjects. The prevalence of any of the three degenerative changes were neither significantly different among males and females nor across BMI groups (p> 0.05) (Tab. 19).

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Tab. 18. A table comparing the prevalence of AT calcifications with various characteristics of Diabetics

Variables

Diabetics

p value*

AT calcifications

Present Absent Total

Age (years)

40 – 49 0 (0.0) 15 (100.0) 15 (100.0)

0.512

50 – 59 1 (6.3) 15 (93.8) 16 (100.0)

60 – 69 4 (13.8) 25 (86.2) 29 (100.0)

70 – 79 1 (5.0) 19 (95.0) 20 (100.0)

Gender

Male 3 (10.0) 27 (90.0) 30 (100.0)

0.667

Female 3 (6.0) 47 (94.0) 50 (100.0)

BMI

Normal 3 (8.1) 34 (91.9) 37 (100.0)

0.564

Overweight 1 (3.8) 25 (96.2) 26 (100.0)

Obese 2 (11.8) 15 (88.2) 17 (100.0)

DM Duration (months)

< 5years 2 (4.7) 41 (95.3) 41 (100.0)

0.295

5 - 10 years 2 (8.3) 22 (91.7) 24 (100.0)

> 10 years 2 (15.4) 11 (84.6) 13 (100.0)

Any PN

Present 5 (8.8) 52 (91.2) 57 (100.0)

0.667

Absent 1 (4.3) 22 (95.7) 23 (100.0)

FBG

< 5.6 (mmol/L) 2 (12.5) 14 (87.5) 16 (100.0)

0.203 5.6 - 6.9 (mmol/L) 0 (0.0) 25 (100.0) 25 (100.0)

≥ 7.0 (mmol/L) 4 (10.3) 35 (89.7) 39 (100.0)

HBA1c

Poor (HbA1c ≥ 7.0%) 3 (5.9) 48 (94.1) 51 (100.0)

0.662 Good (HbA1c < 7.0%) 3 (10.3) 26 (89.7) 29 (100.0)

* - Fisher's exact p value Significant p<0.05

FBG-fasting blood glucose

PN- peripheral neuropathy BMI- body mass index

HBA1c- glycated hemoglobin

76

Tab. 19. A table comparing the prevalence of various degenerative changes with the characteristics of controls

variables Present Absent Total χ2 p value

Disorganized AT fibres Age (years)

40 - 49 0 (0.0) 16 (100.0) 16 (100.0)

0.044*

50 - 59 2 (13.3) 13 (86.7) 15 (100.0) 60 - 69 7 (25.0) 21 (75.0) 28 (100.0) 70 - 79 7 (33.3) 14 (66.7) 21 (100.0) Gender

Male 8 (23.5) 26 (76.5) 34 (100.0)

0.460 0.497

Female 8 (17.4) 38 (82.6) 36 (100.0)

BMI (Kg/m2)

Normal 7 (17.5) 33 (82.5) 40 (100.0)

1.615 0.446 Overweight 8 (26.7) 22 (73.3) 30 (100.0)

Obese 1 (10.0) 9 (90.0) 10 (100.0)

AT hypoechoic foci Age (years)

40 - 49 0 (0.0) 16 (100.0) 16 (100.0)

0.035*

50 - 59 0 (0.0) 15 (100.0) 15 (100.0)

60 - 69 2 (7.1) 26 (92.9) 28 (100.0)

70 - 79 5 (23.8) 16 (76.2) 21 (100.0) Gender

Male 3 (8.8) 31 (91.2) 34 (100.0)

1.000*

Female 4 (8.7) 42 (91.3) 46 (100.0)

BMI (Kg/m2)

Normal 3 (7.5) 37 (92.5) 40 (100.0)

0.327*

Overweight 2 (6.7) 28 (93.3) 30 (100.0)

Obese 2 (20.0) 8 (80.0) 10 (100.0)

AT calcifications Age (years)

40 - 49 0 (0.0) 16 (100.0) 16 (100.0)

1.000*

50 - 59 0 (0.0) 15 (100.0) 15 (100.0)

60 - 69 1 (3.6) 27 (96.4) 28 (100.0)

70 - 79 1 (4.8) 20 (95.2) 21 (100.0)

Gender

Male 0 (0.0) 34 (100.0) 34 (100.0)

0.505*

Female 2 (4.3) 44 (95.7) 46 (100.0)

BMI (Kg/m2)

Normal 1 (2.5) 39 (97.5) 40 (100.0)

1.000*

Overweight 1 (3.3) 29 (96.7) 30 (100.0)

Obese 0 (0.0) 10 (100.0) 10 (100.0)

*Fisher’s exact p values Significant p<0.05 χ2 – chi square

77

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