Diabetes Prevention Program Outcomes Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,779
- 试验地点
- 1
- 主要终点
- Development of Diabetes.
研究概览
简要总结
The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.
DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations.
The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.
详细描述
The current DPPOS Executive Summary and protocol, as well as DPPOS protocol and lifestyle manuals and publications are available at: http://www.dppos.org
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
盲法说明
Open label phase for metformin
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation as a volunteer in the Diabetes Prevention Program (DPP).
排除标准
- 未提供
研究组 & 干预措施
2 Original Metformin
randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.
干预措施: Metformin (Drug)
1 Original Lifestyle
randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2
干预措施: DPPOS Group Lifestyle (Behavioral)
1 Original Lifestyle
randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2
干预措施: DPPOS Boost Lifestyle (Behavioral)
1 Original Lifestyle
randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2
干预措施: Intensive Lifestyle Group Session (Behavioral)
2 Original Metformin
randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.
干预措施: DPPOS Group Lifestyle (Behavioral)
2 Original Metformin
randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.
干预措施: Intensive Lifestyle Group Session (Behavioral)
3 Original Placebo
randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2
干预措施: DPPOS Group Lifestyle (Behavioral)
3 Original Placebo
randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2
干预措施: Intensive Lifestyle Group Session (Behavioral)
结局指标
主要结局
Development of Diabetes.
时间窗: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level \>= 126 mg/dL \[7.0 mmol/L\] or 2-hour plasma glucose \>= 200 mg/dL \[11.1 mmol/L\], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).
Prevalence of Aggregate Microvascular Complication
时间窗: Outcomes were assessed from 2012-2013 (approximately 2 years).
Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (\<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (\> 30mg/gm, confirmed).
Total Cancer Except Non-melanoma Skin Cancer
时间窗: Outcomes were assessed from 1996-2020 (approximately 24 years).
All primary incident cancers except non-melanoma skin cancer
Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
时间窗: Outcomes were assessed from 1996-2025 (approximately 29 years).
Defined as MI, stroke and CVD death. These outcomes were collected since randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
Number of Participants With Diabetes.
时间窗: Outcomes were assessed from 1996-2020 for median follow-up of 21 years and a maximum follow-up of 23 years including a median of 3 years in DPP in all participants enrolled in DPPOS.
Primary outcome defined according to American Diabetes Association criteria (fasting plasma glucose level \>= 126 mg/dL \[7.0 mmol/L\] or 2-hour plasma glucose \>= 200 mg/dL \[11.1 mmol/L\], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).
Number of Participants With Total Cancer Except Non-melanoma Skin Cancer
时间窗: Outcomes were assessed from 1996-2020 (approximately 24 years).
All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
时间窗: Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
次要结局
- Short Physical Performance Battery(Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.)
- Subclinical Atherosclerosis(Outcomes were assessed from 2012-2013 (approximately 2 years).)
- Cognitive Function(Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.)
- Frailty(Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.)
- Mortality(Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018.)
- Cognitive Function(Outcomes were assessed in visit year 8 starting in 2010)
- Short Physical Performance Battery(Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012, and 2017, respectively)
- Frailty(Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017)
- Mortality(Outcomes were assessed throughout follow-up from 1996 to 2019. National Death Index search conducted in 2019 using early release data as of Dec 2018.)