Diabetes In Sindhi Families In Nagpur (DISFIN)

NCT03918525 | Completed

• 1 other identifier: RPC#23A
• Study Type: observational
• Target: 1,462
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Insulin resistance

  March 1, 2016 - Feb 28, 2017

• Hypertension

  March 1, 2016 - Feb 28, 2017

• Obesity

  March 1, 2016 - Feb 28, 2017

• Central obesity

  March 1, 2016 - Feb 28, 2017

• Dyslipidemia

  March 1, 2016 - Feb 28, 2017

Interventions

Sindhi families OTHER

It is an observational study and no intervention is involved

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

To facilitate centralized data and sample collection, we established two Participant Recruitment Centers - one each in Jaripatka and Khamla. These Centers were equipped with facilities to conduct interviews, collect anthropometric data, conduct random blood sugar measurements and collect blood and urine samples for transport and storage.

You may qualify if:

• Resident of Jaripatka or Khamla areas of Nagpur
• Self-reported Sindhi
• Age ≥20 years
• Has given informed consent

You may not qualify if:

• Pregnant or lactating woman
• Known type 1 diabetes

Sponsors & Collaborators

• Lata Medical Research Foundation, Nagpur: lead

Study Sites (1)

Lata Medical Research Foundation

Nagpur, Maharashtra, 440022, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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).

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Manju R Mamtani, MD

  Treasurer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: April 17, 2019
• Study Start: February 20, 2017
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

IN (1)