Comparison of Little Millet based Dinner Versus a standard diet on Glycaemic Control Among Type 2 Diabetic Patients From Eastern India: A randomized open label pilot trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To assess the change in HbA1C in type 2 diabetic patients receiving Little Millet
研究概览
简要总结
Little Millet, known for its low glycemic index and high fiber content, may offer advantages over conventional rice based dinners which is common in Bengal. There is paucity of studies from Eastern part of India regarding effectiveness of Little Millet based diet for glycemic control in diabetics. This study aims to evaluate the effects of little millet based dinner of diabetic patients in West Bengal. By focusing on the evening meal, the study addresses a critical period as blood glucose level typically rise at early morning, potentially exacerbating hyperglycemia. The findings could provide evidence for dietary interventions tailored to local preferences and agricultural practices, promoting sustainable and culturally acceptable dietary changes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •With written informed consent HbA1C: 7-9 Percentage Age: 18 to 65 years Patients already on oral hypoglycaemic agents.
排除标准
- •Presence of: Type 1 diabetes Patients with BMI more than 40 Pregnant and lactation Patients with history of renal disease (eGFR less than 60), chronic liver disease, malignancies, heart failure (NYHA III and IV), uncontrolled thyroid diseases, Cushing’s disease, autoimmune diseases, HIV and other disease that can affect body weight, any haematological disorders.
- •History of current eating disorders or current smoking Patient on high dose of steroids Patient on hormonal therapy Patients on insulin therapy Having any intolerance to Little Millet Non consenting patient.
结局指标
主要结局
To assess the change in HbA1C in type 2 diabetic patients receiving Little Millet
时间窗: 3 months
based dinner as compared to Standard diet
时间窗: 3 months
次要结局
- To find out the changes in the following health parameters:-(a) Body Mass Index (BMI))
研究者
Dr Arindam Naskar
School of Tropical Medicine