Diabetes Prevention Program Pilot Study

Study Overview
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Brief Summary
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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).

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

Conditions
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Diabetes Prevention

Intervention / Treatment
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* Behavioral: DPP
* Behavioral: DPP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Subject will be randomly assigned to work with providers at Clinton Medical Associates | Behavioral: DPP<br>* The primary outcome measure is weight loss with a goal of 7% of initial weight. Secondary outcomes are adherence to behavior changes: Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week 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<br>|
| Active Comparator: 2<br>Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125 | Behavioral: DPP<br>* The primary outcome measure is weight loss with a goal of 7% of initial weight. Secondary outcomes are adherence to behavior changes: Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week |  | 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 |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Prevention, Pre-Diabetes, Exercise, Fat Intake, Fasting blood sugar, tobacco cessation