Diabetes Mellitus, Type 2 Clinical Trial
— DISFINOfficial title:
Diabetes In Sindhi Families In Nagpur (DISFIN): An Observational Study
NCT number | NCT03918525 |
Other study ID # | RPC#23A |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 20, 2017 |
Est. completion date | February 20, 2018 |
Verified date | April 2019 |
Source | Lata Medical Research Foundation, Nagpur |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1462 |
Est. completion date | February 20, 2018 |
Est. primary completion date | February 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: 1. Resident of Jaripatka or Khamla areas of Nagpur 2. Self-reported Sindhi 3. Age =20 years 4. Has given informed consent Exclusion Criteria: 1. Pregnant or lactating woman 2. Known type 1 diabetes |
Country | Name | City | State |
---|---|---|---|
India | Lata Medical Research Foundation | Nagpur | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Lata Medical Research Foundation, Nagpur |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Type 2 diabetes | 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 | March 1, 2016 - Feb 28, 2017 | |
Secondary | Insulin resistance | Insulin resistance will be measured using the Homeostatic Model of Assessment-Insulin resistance (HOMA_IR) | March 1, 2016 - Feb 28, 2017 | |
Secondary | Hypertension | Hypertension will be defined using the 2017 revised criteria (systolic blood pressure >120 mmHg and/or diastolic blood pressure >80 mmHg) | March 1, 2016 - Feb 28, 2017 | |
Secondary | Obesity | Obesity will be defined as body mass index (BMI) exceeding 30 Kg/m2. BMI will be calculated as weight (in Kg)/Height2 (in meters). | March 1, 2016 - Feb 28, 2017 | |
Secondary | Central obesity | 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). | March 1, 2016 - Feb 28, 2017 | |
Secondary | Dyslipidemia | 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. | March 1, 2016 - Feb 28, 2017 |
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