Diabetes In Sindhi Families In Nagpur (DISFIN) (DISFIN)
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|ClinicalTrials.gov Identifier: NCT03918525|
Recruitment Status : Completed
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Other: Sindhi families|
At each Participant Recruitment Center:
- 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.
- 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.
- 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.
- 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.
- 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.
- Then the participant were given a urine sample collection cup. The urine sample was used to estimate urine sugar and microalbuminuria.
- The participant were then given an appointment for fasting blood studies.
- 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).
- 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.
- 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.
- Lastly, we provided a nominal time compensation for each participant who completed all the study procedures.
|Study Type :||Observational|
|Actual Enrollment :||1462 participants|
|Official Title:||Diabetes In Sindhi Families In Nagpur (DISFIN): An Observational Study|
|Actual Study Start Date :||February 20, 2017|
|Actual Primary Completion Date :||February 20, 2018|
|Actual Study Completion Date :||February 20, 2018|
- Other: Sindhi families
It is an observational study and no intervention is involved
- Type 2 diabetes [ Time Frame: March 1, 2016 - Feb 28, 2017 ]Presence of T2D will be defined as: Self-report or FPG ≥126 mg/dl or currently receiving antidiabetic drugs or HbA1c ≥6.5% or random blood sugar ≥ 200 mg/dl
- Insulin resistance [ Time Frame: March 1, 2016 - Feb 28, 2017 ]Insulin resistance will be measured using the Homeostatic Model of Assessment-Insulin resistance (HOMA_IR)
- Hypertension [ Time Frame: March 1, 2016 - Feb 28, 2017 ]Hypertension will be defined using the 2017 revised criteria (systolic blood pressure >120 mmHg and/or diastolic blood pressure >80 mmHg)
- Obesity [ Time Frame: March 1, 2016 - Feb 28, 2017 ]Obesity will be defined as body mass index (BMI) exceeding 30 Kg/m2. BMI will be calculated as weight (in Kg)/Height2 (in meters).
- Central obesity [ Time Frame: March 1, 2016 - Feb 28, 2017 ]Central obesity will be defined using population-specific cut off for waist circumference. For Asian Indians, the cutoffs are: male (>=90cm) and female (>=80 cm).
- Dyslipidemia [ Time Frame: March 1, 2016 - Feb 28, 2017 ]We will use the definition of dyslipidemia as described by the International Diabetes Federation (IDF). The criteria use dyslipidemia is a composite outcomes based on measured values of serum triglycerides (≥ 150 mg/dLmg/dl) and high density lipoprotein (HDL) cholesterol (< 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females). Additionally, total serum cholesterol (≥200 mg/dl) will also be considered as dyslipidemia.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918525
|Lata Medical Research Foundation|
|Nagpur, Maharashtra, India, 440022|
|Principal Investigator:||Manju R Mamtani, MD||Treasurer|