VDR Gene Polymorphisms and Weight Loss in Non-diabetic Overweight and Obese Subjects
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|ClinicalTrials.gov Identifier: NCT03386331|
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : February 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: diet and exercise||Not Applicable|
This is a six months intervention study in non-diabetic overweight and obese subjects. Subjects will be counseled for weight loss through diet and exercise. Diet and exercise will be recommended as per the regular norms for weight loss (weight loss ≥10% from baseline weight will be considered as a significant loss of weight) for overweight and obese subjects. A sample size of 90 subjects was calculated but assuming a drop out rate of 20%, 110 subjects will be enrolled. Enrolled subjects will be measured at every visit (monthly) for weight, body composition measures of abdominal obesity and skin folds. They would be assessed for compliance with diet and exercise. Detailed analysis of body composition including DXA, biochemical analysis will be performed at enrollment and after six months intervention. Statistical analysis will be performed to find association between measures of body composition for weight loss and genotypes of the VDR polymorphisms.
Polymorphisms in the VDR gene have been identified through out the complete VDR gene region and associated with cancer and autoimmune diseases. The FokI polymorphism is present in the translation site and results in the VDR protein being shortened by three amino acids and is not linked with any other VDR polymorphisms. This polymorphism predisposes to bone-disease, risk of cancer, immune mediated diseases 147-149,150, 151.
The common VDR gene polymorphisms are BsmI, TaqI, ApaI and FokI. These polymorphisms have shown varying results with insulin sensitivity and secretion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Influence of Vitamin D Receptor (VDR) Gene Polymorphisms (BsmI, TaqI, ApaI, FokI) on Weight Loss by Diet and Exercise Interventions in Non-diabetic Overweight and Obese Subjects|
|Actual Study Start Date :||March 16, 2016|
|Estimated Primary Completion Date :||March 30, 2019|
|Estimated Study Completion Date :||March 30, 2019|
|Diet and Exercise||
Behavioral: diet and exercise
Diet and lifestyle intervention
- Body weight (Kg) [ Time Frame: 6 months ]weight loss
- Genetic polymorphism [ Time Frame: 6 months ]BsmI, TaqI, ApaI, FokI
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): NCT03386331
|Contact: Anoop Misra, MD||49101222||Anoopmisra@gmail.com|
|New Delhi, India|
|Contact: Anoop Misra, MD|