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Lifestyle Changes + Metformin for Diabetes Prevention (DPPOS Trial)

Phase 3

Waitlist Available

Led By Kishore Gadde, MD

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participation as a volunteer in the Diabetes Prevention Program (DPP)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.

Awards & highlights

Pivotal Trial

Summary

This trial looks at the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population. Lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.

Who is the study for?

This trial is for volunteers who were part of the Diabetes Prevention Program, focusing on those at high risk due to impaired glucose tolerance. It's particularly aimed at understanding long-term health outcomes in diverse populations, including a significant minority representation.

What is being tested?

The study tests the long-term effects of lifestyle interventions and metformin on preventing diabetes. DPPOS-3 specifically looks into how these approaches impact cardiovascular disease and cancer risks as the participant group ages.

What are the potential side effects?

While specific side effects are not listed here, generally, lifestyle changes may include diet and exercise adjustments with minimal risk. Metformin can cause stomach upset, diarrhea, or other gastrointestinal issues in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Development of Diabetes.

Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)

Prevalence of Aggregate Microvascular Complication

+1 more

Secondary study objectives

Cognitive Function

Frailty

Mortality

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: 1 Original LifestyleActive Control3 Interventions

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

Group II: 2 Original MetforminActive Control3 Interventions

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.

Group III: 3 Original PlaceboPlacebo Group2 Interventions

randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2

0 / 1Eligibility criteria met