Completed

Lifestyle and Pharmacological Interventions for Type 2 Diabetes Prevention in High-Risk Individuals

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Study Aim

This study aims to prevent the development of type 2 diabetes in high-risk individuals by evaluating the effectiveness of lifestyle changes and pharmacological interventions, with the primary outcome being the diagnosis of diabetes based on annual glucose-tolerance tests or semi-annual fasting plasma glucose tests.

What is being tested

Placebo

+ Metformin

+ Intensive lifestyle

DrugBehavioral
Who is being recruted

Behavior+9

+ Endocrine System Diseases

+ Hyperglycemia

Over 25 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: July 1996
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: March 2, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1996

Actual date on which the first participant was enrolled.

The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.

NCT00004992
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: March 2, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3234 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 25 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorEndocrine System DiseasesHyperglycemiaImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2HypersensitivityMotor ActivityGlucose Intolerance

Criteria

2 inclusion criteria required to participate
BMI >= 24 kg/m2
Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)
6 exclusion criteria prevent from participating
Conditions or behaviors likely to effect conduct of the DPP
Diabetes or disordered glucose metabolism
Exclusions related to medications
Fasting triglyceride level < 600 mg/dl
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Group II

Active Comparator

Group III

Active Comparator

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd

Rockville, United StatesOpen George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd in Google Maps
CompletedOne Study Center