Diabetes Prevention Program Pilot Study (DPP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00729079 |
Recruitment Status :
Completed
First Posted : August 6, 2008
Last Update Posted : October 12, 2015
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Prevention | Behavioral: DPP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | October 2009 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Subject will be randomly assigned to work with providers at Clinton Medical Associates
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Behavioral: DPP
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Active Comparator: 2
Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125
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Behavioral: DPP
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- The primary outcome measure is weight loss with a goal of 7% of initial weight. [ Time Frame: 6 months ]
- 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 ]
- ;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 ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729079
United States, New York | |
Clinton Medical Associated | |
Rochester, New York, United States, 14620 | |
Therapeutic Lifestyle Changes | |
Rochester, New York, United States, 14620 |
Principal Investigator: | Geoffrey C Williams, MD, PhD | University ofRochester | |
Principal Investigator: | Heather Patrick, PhD | University of Rochester |
Publications:
Responsible Party: | Geoffrey Williams, Professor, University of Rochester |
ClinicalTrials.gov Identifier: | NCT00729079 |
Other Study ID Numbers: |
24895 |
First Posted: | August 6, 2008 Key Record Dates |
Last Update Posted: | October 12, 2015 |
Last Verified: | March 2013 |
Diabetes Prevention Pre-Diabetes Exercise |
Fat Intake Fasting blood sugar tobacco cessation |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |