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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 : December 29, 2017
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Dr Anoop Misra, Diabetes Foundation, India

Brief 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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: diet and exercise Not Applicable

Detailed 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.


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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Diet and Exercise Behavioral: diet and exercise
Diet and lifestyle intervention




Primary Outcome Measures :
  1. Body weight (Kg) [ Time Frame: 6 months ]
    weight loss


Secondary Outcome Measures :
  1. Genetic polymorphism [ Time Frame: 6 months ]
    BsmI, TaqI, ApaI, FokI



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Anoop Misra, MD 49101222 Anoopmisra@gmail.com

Locations
India
Anoop misra Recruiting
New Delhi, India
Contact: Anoop Misra, MD         
Sponsors and Collaborators
Diabetes Foundation, India
Indian Council of Medical Research

Responsible Party: Dr Anoop Misra, Director, Diabetes Foundation, India
ClinicalTrials.gov Identifier: NCT03386331     History of Changes
Other Study ID Numbers: 5/4/8-9/11/NCDII
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes