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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Body weight (Kg)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-60 yrs
- •BMI ≥ 23 kg/m2
排除标准
- •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
研究组 & 干预措施
Diet and Exercise
干预措施: diet and exercise (Behavioral)
结局指标
主要结局
Body weight (Kg)
时间窗: 6 months
weight loss
次要结局
- Genetic polymorphism(6 months)
研究者
Dr Anoop Misra
Director
Diabetes Foundation, India