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临床试验/CTRI/2025/08/092869
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.

Indira Gandhi Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年8月27日最近更新:

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

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Buvana Loshana K

Indira Gandhi Medical College and Research Institute

研究点 (1)

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