Randomized controlled trial to evaluate the effectiveness of a community based intense lifestyle intervention program to facilitate the regression to normoglycemia among women with isolated impaired fasting glucose in Kasaragod district, Kerala, India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- Incidence of regression from iIFG to normoglycemia at 24 months
研究概览
简要总结
India has the second-largest number of people (77 million) living with T2DM, next only to China, with at least as many more undiagnosed. Kerala, the southernmost State of India is the most advanced state in epidemiological transition with the highest prevalence of T2DM (nearly 20 %) and its risk factors in the country. High prevalence rates of overweight (nearly half) and physical inactivity among women in Kerala pose a continuing threat to the T2DM burden. Most landmark lifestyle modification trials were done on individuals with impaired glucose tolerance (IGT) as it is a better predictor of micro-vascular complications and metabolic syndrome and is a strong predictor of cardiovascular complications. However, the annual risk to the progression of T2DM is over 5 times for individuals with isolated impaired glucose tolerance (iIGT), 7 times for isolated impaired fasting glucose (iIFG) and over 12 times for those with both IFG and IGT when compared to normoglycemic individuals. Till date, only three large trials, one in Japan and two in India were conducted to prevent T2DM among individuals with iIFG. However, all the three trials targeted individuals across pre-diabetes spectrum and found lower risk reduction among the iIFG group when compared to iIGT and IGT+IFG group. Lack of evidence on positive effects of lifestyle modification in the iIFG group among Asian Indians warrant further exploration on strategies to reduce the incidence of T2DM as individuals with isolated impaired fasting glucose constitute a major group (57.5%) in the pre-diabetes spectrum among Indians. Furthermore, it is vital to see the effect of intense lifestyle modification intervention across the IFG spectrum in a representative sample of individuals with IFG. Early regression to normoglcemia in people with impaired glucose regulation is associated with reduction in T2DM and no trials have shown such effects in those with i-IFG.
This study aims to assess the effectiveness of a community based intense lifestyle modification program among women with isolated impaired fasting glucose in regression from dysglycemic state (iIFG) to normoglycemia. Collectivistic family centered decision making over individualistic in Kerala emphasizes the importance of peer support, family involvement and community engagement for a sustained behaviour change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •(I) Inclusion criteria for screening (stage 1): 1)Women aged 30-60 years, 2) able to read, write and speak Malayalam, the local language 3) consents to participate in the study, 4) not a known diabetic, 5) no prior history of GDM (II) Inclusion criteria for the trial (stage 4): Participants should satisfy all the inclusion criteria for screening and should be diagnosed with isolated impaired fasting glucose in OGTT.
排除标准
- •(i)Exclusion criteria for screening: -Women with T2DM, diabetes in pregnancy -With prior history of GDM, having chronic illnesses/ disease conditions or on medications that alter glucose metabolism will be excluded.
- •Women with mental illness based on ICD-10 classification44 will also be excluded (ii) Exclusion criteria for the trial: all exclusion criteria for screening and also the newly diagnosed with diabetes or diabetes in pregnancy will be excluded.
- •A screening questionnaire will be used to ensure that participants meet the inclusion and exclusion criteria.
结局指标
主要结局
Incidence of regression from iIFG to normoglycemia at 24 months
时间窗: Incidence of regression from iIFG to normoglycemia at 24 months
次要结局
- 1. Glycemic level assessment(2. Lipid profile assessment)