Remission of Type 2 Diabetes Mellitus through Dietary and Behavioural interventions: A Randomised controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- (a) Number of patients with behavioural and dietary interventions who achieved remission in patients
研究概览
简要总结
The study titled " Achieving remission in patients with Type 2 Diabetes Mellitus through Behavioural and dietary interventions : A Randomised Control Trial" will begin with recruitment after permission is received from CTRI . The primary study objective is to acheive remission in patients with Type 2 Diabetes Mellitus using dietary and behavioural interventions . The dietary intervention will consist of administration of a Millet based and a low carbohydrate diet , the behavioural intervention will include graded assimilation of physical activity , yoga session , awareness about diabetes and associated complications, tobacco and alcohol cessation . IEC activities will be conducted in the form of face to face interviews and group sessions . The intervention will be for 6 months and subsequently the patients will be randomised into intervention and control group at the end of sixth month and will be followed up for further 3 months, The end of trial assessment will be carried out at the end of 9th month in which remission status acheived will be observed . The number of study sites in the trial will be 1 and prior permission of IEC of PGIMER Chandigarh has been obtained
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to participate in the study Patients satisfying the diagnostic criteria of Type 2 Diabetes Mellitus as per HEARTS D Module and World NCD Federation guidelines.
排除标准
- •Patients unwilling to participate in the study Patients with Type 1 Diabetes Pre-diabetes Patients on Insulin.
结局指标
主要结局
(a) Number of patients with behavioural and dietary interventions who achieved remission in patients
时间窗: (a) Number of patients with behavioural and dietary interventions who achieved remission in patients | (b) What is acceptability and understand barriers to adopt dietary interventions especially millets | (c) IEC material in hindi the form of hand bills/ booklets for promotion and acceptability of dietary and behavioural interventions | The patients will be assessed at baseline , 3 months , 6 months and 9 months
(b) What is acceptability and understand barriers to adopt dietary interventions especially millets
时间窗: (a) Number of patients with behavioural and dietary interventions who achieved remission in patients | (b) What is acceptability and understand barriers to adopt dietary interventions especially millets | (c) IEC material in hindi the form of hand bills/ booklets for promotion and acceptability of dietary and behavioural interventions | The patients will be assessed at baseline , 3 months , 6 months and 9 months
(c) IEC material in hindi the form of hand bills/ booklets for promotion and acceptability of dietary and behavioural interventions
时间窗: (a) Number of patients with behavioural and dietary interventions who achieved remission in patients | (b) What is acceptability and understand barriers to adopt dietary interventions especially millets | (c) IEC material in hindi the form of hand bills/ booklets for promotion and acceptability of dietary and behavioural interventions | The patients will be assessed at baseline , 3 months , 6 months and 9 months
次要结局
- Number of patients with Hypertension who became normotensive at the end of 9th month(The data pertaining to hypertensive patients became normotensive at the end of 9th month)
研究者
Arunjeet Singh
PGIMER Chandigarh