CTRI/2025/08/092869尚未招募不适用
A Randomised control trial to assess the feasibility, acceptability and effect of low carbohydrate dietary education in glycaemic control and diabetic remission among type II Diabetes mellitus patients aged 30-50 years- Mixed method study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Glycaemic control
研究概览
简要总结
This is a Randomised controlinterventional study involving two clusters from Karikalampakkam and Lawspet subcentres, randomized into study and control groups.
- Baseline Data Collection: Informed consent will be obtained. Sociodemographic details, clinical examinations, and investigations including FBS, HbA1c, and lipid profile will be recorded.
- Glycemic Monitoring: GMR (Glucose Monitoring Record) will be assessed monthly via Health and Wellness Centres (HWC) by the investigator. This data will guide anti-diabetic drug titration (intensification or de-intensification) alongside HbA1c test willl be done on 3.6.and 12 month and symptoms of hypoglycemia or hyperglycaemia are assesed.
- Intervention (Study Group): Participants will receive dietary education on Low carbohydrate diet weekly for the first month, with BP and glucose checks. Biweekly phone/WhatsApp follow-ups at Weeks 6, 8, and 10 will monitor diet adherence. In-person follow-ups are scheduled at Month 3 and Month 6 .
- Control Group: Will receive standard ICMR guidelines dietary education with monthly follow-ups for 3,6 months.
- Final Follow-up: Both groups will be assessed at 12 months for outcome evaluation.
- Qualitative Component: Focused Group Discussions (FGDs) will be conducted with selected individuals to assess the feasibility, acceptability, challenges, and perceived benefits of dietary interventional education.
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
- 30.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Type II – Diabetes mellitus patients aged between 30 and 50 years and registered at the Health & wellness centres.
- •2.Duration of diabetes less than 2 years.
排除标准
- •1.Patient with known complications of Diabetes mellitus such as foot ulcer, retinopathy, nephropathy, CAD, CVA.
- •2.Currently on insulin therapy 3.Intensive pharmacological treatment of more than 2 antidiabetic drugs.
- •4.Pregnant or lactating women 5.Individuals with significant psychiatric illness or cognitive impairment affecting participation.
- •6.Participants currently following any structured dietary intervention or enrolled in another clinical trial.
- •7.Migrants or individuals unlikely to complete follow-up due to relocation.
- •8.Patient following other alternative forms of medicine.
结局指标
主要结局
Glycaemic control
时间窗: 2 years
次要结局
- 1.Diabetic remission(2.effect of diet in Diabetic complications in Neuropathy, Microalbuminuria and dyslipidaemia)
研究者
Dr Buvana Loshana K
Indira Gandhi Medical College and Research Institute
研究点 (1)
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