- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03918525
Diabetes In Sindhi Families In Nagpur (DISFIN) (DISFIN)
April 15, 2019 updated by: Lata Medical Research Foundation, Nagpur
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
1462
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maharashtra
-
Nagpur, Maharashtra, India, 440022
- Lata Medical Research Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Resident of Jaripatka or Khamla areas of Nagpur
- Self-reported Sindhi
- Age ≥20 years
- Has given informed consent
Exclusion Criteria:
- Pregnant or lactating woman
- Known type 1 diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
March 1, 2016 - Feb 28, 2017
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
March 1, 2016 - Feb 28, 2017
|
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)
|
March 1, 2016 - Feb 28, 2017
|
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).
|
March 1, 2016 - Feb 28, 2017
|
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).
|
March 1, 2016 - Feb 28, 2017
|
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.
|
March 1, 2016 - Feb 28, 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Manju R Mamtani, MD, Treasurer
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 20, 2017
Primary Completion (ACTUAL)
February 20, 2018
Study Completion (ACTUAL)
February 20, 2018
Study Registration Dates
First Submitted
March 13, 2019
First Submitted That Met QC Criteria
April 15, 2019
First Posted (ACTUAL)
April 17, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 17, 2019
Last Update Submitted That Met QC Criteria
April 15, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RPC#23A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
-
Newsoara Biopharma Co., Ltd.RecruitingT2DM (Type 2 Diabetes Mellitus)China
-
Shanghai Golden Leaf MedTec Co. LtdActive, not recruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on Sindhi families
-
RTI InternationalNew Jersey Prevention Network; RWJBarnabas Health Institute for Prevention...RecruitingSubstance-Related Disorders | Adverse Childhood ExperiencesUnited States
-
Federal University of Health Science of Porto AlegreNot yet recruiting
-
University of GeorgiaCompletedSAAF-T | FUEL for Families
-
University of NebraskaCenters for Disease Control and PreventionWithdrawn
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Mathematica Policy Research, Inc.CompletedFamily RelationsUnited States
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)CompletedDisruptive Behavior DisorderFinland
-
Uppsala UniversityRecruitingMaterial and Social Deprivation: An Enforced Lack of Necessary and Desirable Items to Lead an Adequate LifeSweden
-
Centers for Disease Control and PreventionCompletedChild MaltreatmentUnited States