Prospective Interventional Study on Reversibility of Type 2 Diabetes Mellitus With Hypocaloric Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR
研究概览
简要总结
T2DM, a chronic progressive disorder has an epidemic status in India. Remission (HbA1c of < 6.5% without any anti-diabetic medication) of T2DM is achievable with diet modifications in recently diagnosed obese T2D individuals. Studies suggest Very Low Calorie Diet (600 - 800kcal) and Low Calorie Diet-LCD (800 -1000 kcal) using Meal replacers (MR) are helpful. The investigators aimed to study the effects of LCD without any anti diabetic medication in intervention group and later comparing it with Control group (on standard medical treatment).
详细描述
The objective is to study the effect of LCD in anthropometric , biochemical and NAFLD (Non Alcholic Fatty Liver Disease) parameters after 8 weeks and 24 weeks from enrollment.
Purposive sampling is used to enroll participants in the study. The LCD is a combination of one meal replacer and modified major meals. Calculated exchanges of food groups is taken care of in the other two major meals and snacks in between. Inorder to adhere compliance clinical (at baseline, after 8 weeks, after 24 weeks) as well as virtual visits through whatsapp, e-mails, SMS, phone calls (once a week during 8 weeks of intervention and further once a month upto 24 weeks) are scheduled. After 8 weeks of LCD, calorie is increased to 1200-1400 Kcal/day. In the control group the standard medical treatment is continued.
The data is collected in case report form and analysed using SPSS software by statistician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with BMI ≥ 30 kg/m^2
- •DM history of less than 6 years.
- •HBA1C of 6.5-8.5 %.
- •On two or less than two diabetes medication.
排除标准
- •Patients on Insulin
- •Patients having any co morbidity like severe diabetic nephropathy, neuropathy and any other serious illness.
- •Evidence of Type 1 diabetes, ketones and acidosis.
研究组 & 干预措施
Intervention group
Participants in this arm were advised intervention of Low Calorie Diet (800-1000 Kcal/day) for 8 weeks without any anti diabetic medication
干预措施: Low Calorie Diet (Other)
Control Group
Participants in this arm were kept on their standard medical treatment
结局指标
主要结局
Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR
时间窗: up to 24 weeks
To achieve normal HOMA IR range
HbA1c in percentage
时间窗: up to 24 weeks
To bring HbA1c below diagnostic criteria of type 2 diabetes mellitus as per ADA 2020
Weight in kilogram and height in meters will be combined to report BMI in Kg/m^2
时间窗: up to 24 weeks
when obese T2D individuals will have significant improvement in BMI
次要结局
未报告次要终点