Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of Type 2 Diabetes Mellitus, Hepatic and Pancreatic Fat: A Two-year Randomized Control Trial in New Delhi, India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Reversal of diabetes
研究概览
简要总结
An increase in body fat, even when within the normal BMI range is one of the essential drivers of T2DM in Asian Indians. In this context, the relationship between excess hepatic fat and pancreatic fat appears to be necessary. A low-calorie (high protein and low carb) vegetarian diet with appropriate exercise, in a protocol similar to the DiRECT study, may lead to weight loss, reversal of diabetes, and decrease in ectopic fat.
详细描述
Diabetes is one of the biggest global public health problems. India has 100 million people living with diabetes as per the 2023 data. Reversal of T2DM, the holy grail of diabetes management, was not deemed possible until recently. Primary care-led weight management for remission of type 2 diabetes (DiRECT) trial has been conducted in obese patients with T2DM patients for a period of 2 years in the UK. Research on the effect of dietary intervention would be necessary for Asian Indians since liver fat deposition is more severe than in white Caucasians. Although some nutritionists and physicians are replicating methods of DiRECT study in their patients, it is not clear if similar diets will work effectively in community-dwelling Asian Indians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with T2DM within the previous 3 years
- •Age 20-65 years
- •BMI >25-45kg/m2
- •HbA1c> 6.5% at baseline (on current treatment, if any)
- •Exclusion criteria:
- •Recent or screening HbA1c of 9% or higher
- •Weight loss of >5 kg within the previous 6 months
- •Significant cardiopulmonary
- •Hepatic, or another endocrine disease
- •Current participation in any other research drug study in the previous three months
- •Past history of bariatric surgery Malignancy other than minor skin lesions and Possibility of pregnancy
排除标准
- 未提供
结局指标
主要结局
Reversal of diabetes
时间窗: 24 Months
This randomized controlled prospective trial will be of 2 years duration with T2D. These subjects will be randomized into two groups, Group A (intervention group) will receive a professionally supported low-calorie diet along with appropriate exercise counselling; Group B (Control group) will be receiving encouragement to follow standard diet and exercise advice.
次要结局
- Hepatic and Pancreatic Fat(24 Months)
- Anthropometric assessment(24 Months)
- Muscle strength(24 Months)
- Insulin Resistance(24 Months)
- Body fat(24 Months)