Diabetes Prevention Program Pilot Study (DPP)

October 8, 2015 updated by: Geoffrey Williams, University of Rochester

Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study

This pilot study is intended to demonstrate that we can actually deliver the Diabetes Prevention Program intervention well and to show that it is likely effective. We will use results from this pilot study to support our application to The National Institute of Health. NIH is asking for health care centers to show ways to provide this treatment at a reasonable cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention in a primary care health care setting (University of Rochester Primary Care).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14620
        • Clinton Medical Associated
      • Rochester, New York, United States, 14620
        • Therapeutic Lifestyle Changes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • BMI >24 kg/m2 (>22 kg/m2 among Asian Americans)
  • IGT (2-h plasma glucose 140~199 mg/dl based on 75-g OGTT if available). The OGTT will not be required for inclusion, but the CMA practitioners may wish to recommend the OGTT for their patients.
  • Elevated FPG (95~125 mg/dl*).
  • HDL-triglyceride ration > 3.5.

Exclusion Criteria:

  • Diabetes at baseline
  • FPG >126 mg/dl*
  • 2-h plasma glucose >200 mg/dl based on 75-g OGTT, if available. OGTT will not be required (see above note).
  • Diabetes diagnosed by a physician and confirmed by other clinical data, other than during pregnancy.
  • Ever used antidiabetic medication, other than during pregnancy
  • Medical conditions likely to limit life span and/or increase risk of intervention
  • Cardiovascular disease
  • Hospitalization for treatment of heart disease in past 6 months New York Heart Association Functional Class> 2
  • Left bundle branch block or third degree AV block Aortic stenosis
  • Systolic blood pressure> 180 mmHg or diastolic blood pressure> 105 mmHg
  • Cancer requiring treatment in the past 5 years, unless the prognosis is considered good
  • Renal disease (creatinine GFR < or = 30 ml/hr or > 2.0 mg/dl if GFR not available).
  • Anemia (hematocrit <36% in men or <33% in women)
  • Hepatitis (based on history or serum transaminase elevation)
  • Other gastrointestinal disease (pancreatitis, acute inflammatory bowel disease)
  • Recent or significant abdominal surgery
  • Pulmonary disease with dependence on oxygen or daily use of bronchodilators
  • Chronic infection (e.g., HIV, active tuberculosis)
  • Conditions or behaviors likely to affect conduct of the trial
  • Unable to communicate with clinic staff (e.g., read and speak English).
  • Unwilling to accept treatment assignment by randomization
  • Participation in another intervention research project that might interfere with DPP
  • Weight loss of > 10% in past 6 months for any reason except postpartum weight loss
  • Unable to walk 0.25 miles in 10 min
  • Currently pregnant or within 3 months postpartum
  • Currently nursing or within 6 weeks of having completed nursing
  • Pregnancy anticipated during the course of the trial
  • Unwilling to undergo pregnancy testing or report possible pregnancy promptly
  • Unwilling to take adequate contraceptive measures, if potentially fertile
  • Major psychiatric disorder, including severe active major depression, severe anxiety, schizophrenia, manic depression, bi-polar disorder
  • Excessive alcohol intake, either acute or chronic

  • Medications and medical conditions likely to confound the assessment for diabetes including:

    • Niacin, in doses indicated for lowering serum triglycerides
    • Glucocorticoids, systemic
  • Other prescription weight-loss medications
  • Active Thyroid disease, suboptimally treated as indicated by abnormal serum thyroid-stimulating hormone
  • Other endocrine disorders (e.g., Cushing's syndrome, acromegaly)
  • Fasting plasma triglyceride >600 mg/dl, despite treatment

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Subject will be randomly assigned to work with providers at Clinton Medical Associates
Behavioral: DPP
  1. The primary outcome measure is weight loss with a goal of 7% of initial weight.

  2. Secondary outcomes are adherence to behavior changes:

    1. Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
    2. Fat intake less than 25% and saturated fat less than 10%
    3. Fiber intake of at least 25 grams per day
    4. Fasting blood sugar < 100 mg/dL
    5. Absence of tobacco use
Active Comparator: 2
Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125
Behavioral: DPP
  1. The primary outcome measure is weight loss with a goal of 7% of initial weight.

  2. Secondary outcomes are adherence to behavior changes:

    1. Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
    2. Fat intake less than 25% and saturated fat less than 10%
    3. Fiber intake of at least 25 grams per day
    4. Fasting blood sugar < 100 mg/dL
    5. Absence of tobacco use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is weight loss with a goal of 7% of initial weight.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
Time Frame: 6 months
6 months
;Fat intake less than 25% and saturated fat less than 10% Fiber intake of at least 25 grams per day;Fasting blood sugar < 100 mg/dL; Absence of tobacco use
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Geoffrey C Williams, MD, PhD, University ofRochester
  • Principal Investigator: Heather Patrick, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 1, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24895

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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