VDR Gene Polymorphisms and Weight Loss in Non-diabetic Overweight and Obese Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

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.
    

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.
    

Intervention name(s): diet and exercise
Intervention type(s): Behavioral
Intervention description(s): Diet and lifestyle intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science