Status:
COMPLETED
Diabetes Prevention Program Pilot Study
Lead Sponsor:
University of Rochester
Conditions:
Diabetes Prevention
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00729079
Start Date
December 1 2008
End Date
October 1 2009
Last Update
October 12 2015
Active Locations (2)
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1
Clinton Medical Associated
Rochester, New York, United States, 14620
2
Therapeutic Lifestyle Changes
Rochester, New York, United States, 14620