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Lifestyle Changes + Metformin for Diabetes Prevention (DPPOS Trial)

Phase 3

Waitlist Available

Led By Mark Molitch, 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

DPPOS 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.Check my eligibility

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.See study design

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.

DPPOS Trial Eligibility Criteria

Inclusion Criteria

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

DPPOS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Development of Diabetes.

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

Prevalence of Aggregate Microvascular Complication

+1 more

Secondary outcome measures

Cognitive Function

Frailty

Mortality

+2 more

DPPOS 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

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,356 Previous Clinical Trials

4,312,287 Total Patients Enrolled

107 Trials studying Diabetes

138,663 Patients Enrolled for Diabetes

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,671,962 Total Patients Enrolled

5 Trials studying Diabetes

2,288 Patients Enrolled for Diabetes

National Institute on Aging (NIA)NIH

1,668 Previous Clinical Trials

28,002,285 Total Patients Enrolled

25 Trials studying Diabetes

764,926 Patients Enrolled for Diabetes

Media Library

DPPOS Group Lifestyle Clinical Trial Eligibility Overview. Trial Name: NCT00038727 — Phase 3

Diabetes Research Study Groups: 1 Original Lifestyle, 2 Original Metformin, 3 Original Placebo

Diabetes Clinical Trial 2023: DPPOS Group Lifestyle Highlights & Side Effects. Trial Name: NCT00038727 — Phase 3

DPPOS Group Lifestyle 2023 Treatment Timeline for Medical Study. Trial Name: NCT00038727 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals that researchers hope to achieve with this clinical trial?

"The objective of this study is to evaluate the long-term effects of a diabetes prevention program on microvascular complications, mortality, physical function, and subclinical atherosclerosis. Outcomes will be assessed over a 12-year period (1996-2008), with data being collected on participants' aggregate microvascular complication rate, all-cause mortality rates, short physical performance battery scores, and levels of subclinical atherosclerosis."

Answered by AI

What other scientific studies have included the medication 2 Original Metformin?

"There are a total of 180 ongoing clinical trials for 2 Original Metformin, 45 of which have reached Phase 3. Although the majority of these medical studies take place in Pittsburgh, Pennsylvania, there are 1952 different locations running trials for 2 Original Metformin globally."

Answered by AI

What are the FDA's thoughts on 2 Original Metformin?

"2 Original Metformin is safe according to our 3-point scale, as it has received Phase 3 clinical trial designation. This means that there is both some evidence of efficacy and multiple rounds of supportive safety data."

Answered by AI

Are there any available positions for participants in this clinical trial?

"According to the latest information on clinicaltrials.gov, this particular study is not presently recruiting patients for participation. Although, there are 1894 other trials that are actively looking for candidates right now. This trial was originally posted on September 1st, 2002 and last updated on December 3rd, 2021."

Answered by AI

What are some common health conditions that 2 Original Metformin is used to manage?

"2 Original Metformin pills can help patients struggling with exercise, type 1 diabetes mellitus, and diabetic ketoacidosis."

Answered by AI

How many people are being signed up for this experiment?

"This research is no longer enrolling new participants. The trial was originally posted on September 1st, 2002 and the most recent edit was made December 3rd, 2021. For those still seeking to join a clinical trial, there are currently 1714 trials actively searching for participants with diabetes mellitus and 180 trials for 2 Original Metformin that have open recruitment."

Answered by AI