longer be eligible for the use of inhaled insulin as a result of decline in lung function9. Concerns for the use of inhaled insulin include accelerating the already impaired ventilatory functions which will increase mortality, effect on the pulmonary microvasulature which will impair further drug delivery and lately concerns of increasing pulmonary malignancies have arisen90,91. Six cases of lung cancer occurred in about four thousand cases of patients on inhaled who were being followed up compared to one case in a similar population of control subjects not taking inhaled insulin. However all the patients were past or present smokers, but the difference was statistically significant and thus raises a lot of concern91.
Provided patients are carefully selected, inhaled insulin is an alternative in the delivery of insulin due to the many reasons highlighted earlier. Though it is not yet readily available here, several brands, which were in advanced stages of clinical trials, have suspended trials for now due to concerns about lung cancer.
Brands are preparations of short acting soluble insulin and are required several times a day often with an injection of basal insulin. “Exubera,” the only inhaled insulin preparation that was licensed for use is no longer being produced by the pharmaceutical company. The main reason was that they did not meet their bottom line because many physicians are reluctant to prescribe it due to concerns of safety, as regards effect on lung function90. The delivery device for
“Exubera” was also cumbersome and not very patient friendly and also limited acceptance by the patients90.
CHAPTER SIX
CONCLUSION AND RECOMMENDATONS Limitations of the study
Despite the findings in this study, some limitations were observed:
1. Lung volumes especially the total lung capacity and the DLCO were not done to clearly determine that restrictive ventilatory defect is present in type 2 DM.
2. Even though the sample size is representative of the DM population in Nigeria, it may have limited the significance of the factors that determine ventilatory function in DM subjects.
CONCLUSION
This study agrees with other studies in the concept of the lungs as another organ adversely affected by DM. This involvement of the lungs by DM affects lung the ventilatory indices.
The main findings in this study are that the PEFR, FEV1 and FVC are significantly lower in DM subjects compared to subjects without DM. The FEV1/FVC is not significantly different between the two groups. These findings suggest that the lung function defect in DM subjects is most likely restrictive. The main factors that determine ventilatory function in DM subjects are age, BMI and the duration of diabetes and these factors have an inverse relationship to the ventilatory indices. This study also shows that up to 84% of Nigerian subjects with type 2
DM, despite having reduced ventilatory functions, may be eligible for the use of inhaled insulin provided the recommended guidelines are followed.
Based on the findings in this study, the following recommendations are made:
1. In order to preserve the already reduced pulmonary reserve, DM subjects should avoid active and passive smoking as well as dusty occupations such as mining and quarrying. Maintaining an ideal weight is also paramount in DM subjects since increasing BMI further reduces lung function.
2. Chronic use of inhaled insulin may affect long-term pulmonary function, while pre existing lung dysfunction may alter the absorption and bioavailability of inhaled insulin, therefore follow up studies of lung function of DM subjects on inhaled insulin is recommended to know the sequel. Present studies are not beyond 4 years90.
3. Further studies comparing pulmonary function with other evidence of diabetic microangiopathy such as microalbuminuria, retinopathy and neuropathy will validate the use of lung function as a non-invasive tool for monitoring diabetic microangiopathy.
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Appendix 1
Joint ATS/ ERS guidelines for performing spirometry Acceptibility and reproducibility criteria summary.
Acceptibility criteria Reproducibility criteria Individual spirograms are “acceptable”
if they are free from the following artifarts:
Cough or glottis closure during the first second of exhalation
Early termination or cut off Variable effort
Leak
Obstructed mouth piece
After 3 acceptable spirograms have been obtained, apply the following tests:
Are the two largest FVC within 0.2 L of each other?
Are the two largest FEV1 within 0.2L of each other? If both of these criteria are met, the test session may be
concluded.
Have a good start
Extrapolated volume less than 5% of FVC or 0.15L, whichever is greater; OR Time to PEF of less than 120 ms
If both of these criteria are not met, continue testing until
Both the criteria are met with analysis of additional acceptable spirograms; OR A total of eight tests have been
performed; OR
The subjects cannot continue Have a satisfactory exhalation Save a minimum of three best
seconds of exhalation/or a plateau in the volume time curve; OR reasonable duration or a plateau in the volume time curve; OR
If the subject cannot continue to exhale
manuvers
Performance standards for an office spirometer
A volume spirometer should :
Accumulate volume for greater than 30 seconds Accommodate volume of volumes up to 7 litres Accurate within 3% or 50ml of test volume
A flow sensing spirometer should : Be able to flow up to 12L/s
Be accurate to within 5% or 0.2L/s
Both need:
Regular maintenance
Routine checks of accuracy of the spirometer and the computer.
APPENDIX 2
APPENDIX 3
INFORMED CONSENT FORM
Research Study: Ventilatory function tests in subjects with type 2 diabetes mellitus at the Lagos University Teaching Hospital (LUTH).
I……….. Hereby consent to participate in the study on ventilatory function tests in subjects with type 2 diabetes mellitus at the Lagos University Teaching Hospital (LUTH).
Dr……….. has explained the nature of the study with its benefits to me.I understand that the Study is to be carried out solely for the purpose of Medical Research and I am willing to act as a volunteer for that purpose. I recognize that the result of the study may be of significant benefit to mankind.
Date:………. Sign………..
Name of Patient………..
Information obtained in this study is strictly confidential . Your data will be identified by a study code number and your name will not be used in
the study. If any information is published , there will not be any which will identify you as a participant.
Dr Ozoh O.B.
APPENDIX 4