Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Change in Hemoglobin A1c (HbA1c)
研究概览
简要总结
Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.
Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle intervention, with escalation to Metformin therapy will lower the incidence of diabetes among the highest risk pre-diabetic individuals of Caribbean-descent.
详细描述
The investigators propose to conduct a pragmatic trial that tests the effectiveness of lifestyle modification and Metformin use in minority populations. Our study population is Caribbean-descent individuals in Region 2, Trinidad and Barbados. The investigators will have five clinical intervention sites situated in New York - 2, Puerto Rico -1, Barbados -1, Trinidad -1 and US Virgin Islands -1. These sites were chosen because of the investigators' strong research network in these locations, and to enable us to address diabetes disparities due to geographic differences. The investigators will first modify an established lifestyle modification workshop series developed by the East Harlem Partnership for Diabetes Prevention (EHPDP) for use in the community, 10to target the population at the involved clinical sites. The investigators plan to adapt the D-CLIP protocol and escalate to Metformin therapy for the highest risk pre-diabetic patients whose hemoglobin A1c (HbA1c) has not improved or who remain morbidly obese.
The investigators will leverage our existing robust research infrastructure and network at the five sites through our Eastern Caribbean Health Outcomes Research Network (ECHORN) and now the Yale Transdisciplinary Collaborative center for Health Disparities focused on Precision Medicine (Yale-TCC). ECHORN is a research collaboration funded by the NIMHD (U2458849938) to address the burden of chronic disease in USVI, PR and the Eastern Caribbean. The Yale-TCC (U54MD010711) leverages the infrastructure and knowledge of the ECHORN, expands to include New York and New Jersey and focuses on diabetes and hypertension. The investigators' network includes community advisory boards as well as policy delegations that are well suited to inform this project and its expansion into routine healthcare practice and policy.
The control arm of this study was never activated due to COVID-19 restrictions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI>25 or WC>88/102cm
- •No history of type I or type II diabetes or gestational diabetes
- •Not on blood sugar altering medication
- •Ability to attend weekly sessions
- •HbA1c 6-6.4%
排除标准
- •eGFR<45 mL/min/1.73 m2
- •Prescribed Metformin and randomized to the control arm
研究组 & 干预措施
Intervention
Highest risk pre-diabetic patients
干预措施: Lifestyle Intervention (Behavioral)
Intervention
Highest risk pre-diabetic patients
干预措施: Metformin (Drug)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c)
时间窗: Baseline and 12 months
Hemoglobin A1C (HbA1C) test was assessed via clinical tests.
次要结局
- Change in Weight (kg)(Baseline and 6 months)
- Change in Systolic Blood Pressure(Baseline and 6 months)
- Diabetes Risk Score(6 months)
- Change in Diastolic Blood Pressure(Baseline and 6 months)
- Change in Self-Efficacy Score - Worry Scale(6 months)
- Change in Fruit and Vegetable Intake (Total Servings)(Baseline and 6 months)
- Change in Self-Efficacy Score - Personal Control Scale(Baseline and 6 months)
- Change in Physical Activity Level.(Baseline and 6 months)
- Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)(Baseline and 6 months)