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Diabetes Prevention Program Pilot Study (DPP)

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00729079
First received: August 1, 2008
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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).


Condition Intervention
Diabetes Prevention
 Behavioral: DPP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • The primary outcome measure is weight loss with a goal of 7% of initial weight. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • ;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 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2008
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729079

Locations
United States, New York
Therapeutic Lifestyle Changes
Rochester, New York, United States, 14620
Clinton Medical Associated
Rochester, New York, United States, 14620
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Geoffrey C Williams, MD, PhD University ofRochester
Principal Investigator: Heather Patrick, PhD University of Rochester
  More Information

Additional Information:
Diabetes Prevention Program  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Geoffrey C Williams, MD PhD, University of Rochester
ClinicalTrials.gov Identifier: NCT00729079     History of Changes
Other Study ID Numbers: 24895
Study First Received: August 1, 2008
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Diabetes Prevention
Pre-Diabetes
Exercise
 Fat Intake
Fasting blood sugar
tobacco cessation

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013