Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Diabetes In Sindhi Families In Nagpur (DISFIN): An Observational Study
The pandemic of diabetes is increasing at an alarming rate. The prevalence of diabetes has risen in India by 123% over the last decade. In 1990, diabetes was not considered an important contributor to mortality in India but in 2013, it is ranked as the eighth most common cause of deaths in adult Indian population. There is now a growing understanding that diabetes runs in families and has a significant genetic basis. In this regard, it is noteworthy that from an ethnographic standpoint, Sindhi population in India has been both genetically and environmentally at an increased risk of stress, hypertension and cardiovascular diseases. Considering the nexus of metabolic diseases that include hypertension, obesity, dyslipidemia and diabetes it is therefore expected that this population may be at an increased risk of these metabolic conditions. However, exact prevalence of contributors to type 2 diabetes in the Sindhi population is unknown. The proposed study will estimate prevalence of type 2 diabetes in Sindhi families of Nagpur. Both the PIs have extensive experience with family studies which includes construction of pedigrees, using variance components methods, dissecting out genetic and environmental components of diseases and association of critical phenotypic traits with disease. The proposed study will tap this resource with a focus on the Sindhi families of Nagpur which are concentrated in the Jaripatka and Khamla areas. This study will exploit the current infrastructure in the Lata Medical Research Foundation to access these families and conduct a first-of-its-kind study in India. It is expected that this study will pave way for more extensive genetic, epigenetic and environmental studies of this population. It will also foster future collaborations with national and international health agencies. In that vein, the DISFIN pilot study represents the first step towards identification, quantification, prevention and control of type 2 diabetes in central India.
At each Participant Recruitment Center:
1. We announced the dates of recruitment locally through pamphlet distribution, personal
conversations, emails and a study website to the residents of the study areas. When the
participants came in for the study, they were first administered the informed consent
form.
2. Upon receiving such consent a Field Research Officer (FRO) appointed specifically for
the study collected the demographic data and conduct anthropometric measurements. All
the data has been directly input into a cloud-based database through tablet computers
made available to the FROs for the purpose of the study.
3. A trained nurse then measured the blood pressure of the participant as follows: These
measurements were conducted using a random-zero sphygmomanometer on the left arm. To
account for the potential variability in the blood pressure measurements, we measured
the blood pressure thrice with 5-minute intervals but use the average of the last two
readings as the phenotypic trait value. Appearance of the first Korotkov sound and
disappearance of the fifth Korotkov sound was considered as the systolic and diastolic
blood pressures, respectively.
4. Thereafter the participant were under electrocardiographic evaluation. The examination
was conducted by a trained ECG technician using a portable ECG machine with limb leads,
chest leads and augmented leads. The signal recordings were digitized and stored as
digital signal files. Novacode software was used to quantitatively measure important
phenotypic traits from the ECG signals.
5. The participant then proceeded to measurement of random blood glucose using a glucometer
and disposable test strip. The results are shared with the participant as well as
entered directly into the cloud-based database.
6. Then the participant were given a urine sample collection cup. The urine sample was used
to estimate urine sugar and microalbuminuria.
7. The participant were then given an appointment for fasting blood studies.
8. On the day of the appointment, a trained laboratory technician appointed for the purpose
of the study drew 10 ml of venous blood from the ante-cubital vein. This blood sample
will be used for lipid profile studies (total and free serum cholesterol, serum
triglycerides, high-density lipoproteins, low-density lipoproteins, very low-density
lipoproteins and apolipoproteins), fasting plasma glucose, serum cotinine (to
corroborate the history of smoking), serum creatinine (to quantify urinary dilution),
serum C peptide (to distinguish between type 1 and type 2 diabetes), plasma insulin and
serum HbA1c (glycated hemoglobin).
9. To maximize participation for the fasting blood studies, we sent text reminders to
participants before the date of appointment. If the participant cannot make it on the
day of appointment then we again sent text and/or telephonic reminders to them for a
revised appointment date. We did this for a total of three times before the reminders
can be stopped.
10. If the participants were diagnosed with any medical condition during the examination
then they were duly referred to expert medical help outside of the DISFIN study. If the
participant was newly diagnosed as a case of T2D during study the participant was
referred to expert diabetologist in the city for further medical care.
11. Lastly, we provided a nominal time compensation for each participant who completed all
the study procedures.
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