VDR Gene Polymorphisms and Weight Loss in Non-diabetic Overweight and Obese Subjects

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386331
• Other study ID #: 5/4/8-9/11/NCDII
• Status: Completed
• Phase: N/A
• Start date: March 16, 2016
• Est. completion date: March 30, 2019

Study information

• Verified date: February 2019
• Source: Diabetes Foundation, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 20-60 yrs
• BMI = 23 kg/m2

Exclusion Criteria:

• Type 1 or Type 2 Diabetes.
• On drugs or meal supplements for weight loss.
• On calcium and or vitamin D supplement currently or in the previous six months.
• Have past or current history or family history of renal stones.
• Have participated in any other investigational drug study in the previous three months.
• Have any systemic diseases (cardiac, hepatic, endocrine or renal) or taking any kind of treatment more than one month in the last six months.
• Diagnosed malabsorption (celiac disease, Cohn's, ulcerative colitis) or history suggestive of malabsorption.
• Have past history of bariatric surgery

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• diet and exercise
Diet and lifestyle intervention

Locations

Country	Name	City	State
India	Anoop misra	New Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Diabetes Foundation, India	Indian Council of Medical Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight (Kg)	weight loss	6 months
Secondary	Genetic polymorphism	BsmI, TaqI, ApaI, FokI	6 months