跳至主要内容
临床试验/CTRI/2024/03/064596
CTRI/2024/03/064596招募中不适用

A Retrospective Analysis to Assess the Effect of an Integrated Intensive Lifestyle Intervention among Individuals with Prediabetes /Type 2 Diabetes/Obesity in India

Freedom from diabetes research foundation (Host Institution)1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2024年3月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20,000
试验地点
1
主要终点
1.At least 10% reduction in weight at one year & HbA1c less than 6.5% or 48 mmol/mol without the use of pharmacotherapy at 1 year.

研究概览

简要总结

The Freedom from Diabetes Clinic has been running a lifestyle intervention program for managing diabetes and its complications since its inception in 2013. As such, this comprehensive retrospective analysis aims to explore the effect of the integrated lifestyle management approach that combines diet, exercise, stress, and medical management in patients enrolled in the FFD intensive lifestyle intervention program for diabetes management. Additionally, this study aims to understand population-specific disease and metabolic characteristics along with mental health and stress-related issues, the prevalence of comorbidities, and their impact on glycemic control, and to explore the associations between these parameters in this cohort. Based on retrospective data extracted, the specific objectives of the study are: A) To assess the impact of the ILI (post-intervention effects) on remission (defined as maintaining HbA1c less than 6.5% without the use of glucose-lowering medications), glycemic control, weight loss, reduction in medication use, improvement in comorbidities (hypertension, dyslipidemia, nephropathy,  anxiety, depression, diabetes-related stress), and complications (nephropathy). B) To analyze the baseline characteristics of patients diagnosed with T2D and prediabetes who attended an ILI-based diabetes management program. C) To investigate the associations between clinical, anthropometric, biochemical, and mental health outcomes.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age between 18 to 75 years
  • Confirmed diagnosis of prediabetes or type 2 diabetes and/or BMI more than 23 kg/m2.

排除标准

  • Diabetes type other than type 2 like LADA, MODY, gestational
  • Those with complete data.

结局指标

主要结局

1.At least 10% reduction in weight at one year & HbA1c less than 6.5% or 48 mmol/mol without the use of pharmacotherapy at 1 year.

时间窗: Weight, HbA1c and lipid profile at Baseline, 6 month, 1 year | Mental health questionnaire at baseline and at 6 months

2. BMI below 23 or least 3 point drop

时间窗: Weight, HbA1c and lipid profile at Baseline, 6 month, 1 year | Mental health questionnaire at baseline and at 6 months

3. Reduction in mental health scores to below 10

时间窗: Weight, HbA1c and lipid profile at Baseline, 6 month, 1 year | Mental health questionnaire at baseline and at 6 months

4. At least 10% improvement in lipid levels

时间窗: Weight, HbA1c and lipid profile at Baseline, 6 month, 1 year | Mental health questionnaire at baseline and at 6 months

次要结局

  • Improvement in other biochemical parameters like serum creatinine, eGFR, SGPT, SGOT, urine microalbumiuria, C-reactive protein.(Biochemical parameters will be assessed at baseline, 6 months and at 1 year)

研究者

发起方
Freedom from diabetes research foundation (Host Institution)
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Pramod Tripathi

Freedom from Diabetes Research Foundation

研究点 (1)

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