The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 751
- 试验地点
- 1
- 主要终点
- Diabetes incidence
研究概览
简要总结
The Pre-DICTED (Pre-Diabetes Intervention and Continued Tracking to Ease-out Diabetes) program is a community-based diabetes prevention program. This study aims to test the effectiveness of structured, group-based lifestyle interventions with stepwise addition of metformin, if required, among subjects with pre-diabetes in multi-ethnic Singapore.
详细描述
The Pre-DICTED program is designed as a randomized, controlled, pragmatic trial. The program targets to recruit up to 846 overweight/obese (BMI ≥23.0) adults (age 18-64) with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or IFG + IGT in Singapore. The follow-up period will be 3 years.
Eligible subjects will be identified through community, primary care clinics and hospital-based diabetes screening program. Following informed consent, eligible participants will be randomised into the control or the treatment arm.
Participants in the control arm will receive the current standard of care for pre-diabetes which includes counseling on lifestyle modifications and follow up by primary care physicians.
Participants in the treatment arm will undergo a 3-month, locally tailored, group-based lifestyle intervention program (consisting of nutrition workshops, exercise sessions and goal-setting workshop) plus subsequent stepwise addition of metformin for selected participants at the highest risk of progression to diabetes at ≥ 6 months of follow-up. Financial incentives will be awarded to participants who achieve weight lost of ≥5% of baseline weight during follow-up period.
The primary outcome of diabetes incidence will be assessed bi-annually and compared across the study arms. Secondary outcomes will include weight, waist circumference, fasting plasma glucose (FPG), 2-h glucose, HbA1c, physical activity, diet and metformin adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singapore citizens or permanent residents
- •Age between 18 and 64
- •Body mass index (BMI) ≥ 23.0 kg/m2
- •Pre-diabetes diagnosed based on:
- •fasting plasma glucose 6.1 - 6.9 mmol/L (Impaired fasting glucose; IFG) and/or
- •2-hr plasma glucose in 75g oral glucose tolerance test (OGTT) 7.8 - 11.0 mmol/L (Impaired glucose tolerance; IGT) (Laboratory tests to be done within 6 months of enrolment)
排除标准
- •Individuals with diabetes mellitus
- •Health conditions impeding participation in lifestyle change programme (e.g. active cancer, recent myocardial event within 6 months, heart failure, chronic kidney disease)
- •Current pregnancy or breast feeding
- •Treatment with medications known to alter glucose tolerance
- •Known allergic reaction to metformin
研究组 & 干预措施
Treatment arm
Participants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants.
干预措施: Lifestyle modification (Behavioral)
Treatment arm
Participants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants.
干预措施: Metformin (Drug)
Treatment arm
Participants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants.
干预措施: Financial incentives (Other)
结局指标
主要结局
Diabetes incidence
时间窗: 3 years
The primary outcome, diabetes incidence, will be diagnosed based on a single, annual OGTT or the semi-annual FPG (Fasting plasma glucose) test
次要结局
- Waist circumference(3 years)
- HbA1c(3 years)
- Fasting plasma glucose(3 years)
- 2-hour plasma glucose(3 years)
- International physical activity questionnaire (IPAQ) score(3 years)
- Metformin adherence(Up to 30 months)
- Weight(3 years)