Status:
COMPLETED
Changing Lifestyles for Better Health
Lead Sponsor:
Yale University
Collaborating Sponsors:
Donaghue Medical Research Foundation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
The purpose of this research collaboration between Dr. William Tamborlane, Deputy Directory of the Yale Center for Clinical Investigation (YCCI) and Fair Haven Community Health Center's (FHCHC) Diabet...
Detailed Description
This project is a clinical outcome study that merges the expertise of a senior Yale clinical investigator, the clinical and translational research resources of YCCI, the clinical and community experti...
Eligibility Criteria
Inclusion
- In order to be eligible for this study, the following criteria must be met:
- Subjects must be willing to travel to the clinic for all regularly scheduled study visits, and to the lifestyle intervention program site for the ILI (the John Martinez School).
- Subjects must have had a 2 hour 75 gram Oral Glucose Tolerance Test (OGTT) with fasting glucose between 100 and 126, or 2 hour glucose between 140 and 200 mg/dl in order to participate in this study within the 4 months prior to enrollment.
- Willingness to undergo fasting blood testing: HOMA-IR, fasting lipid profile (including total cholesterol, HDL, LDL cholesterol and triglycerides) at the beginning of the study (if not previously obtained with the OGTT) and repeated at 12 months.
- Subjects must have no medical contraindications to exercise or dieting.
Exclusion
- Subjects will be excluded from the study if they have diabetes or other serious medical or psychiatric condition that would preclude participation in the ILI program.
- Subjects will be excluded if they are taking medications that potentially cause significant weight gain or weight loss (including prescription medication, over the counter medication, or herbal supplements)..
- Women who are pregnant or planning to become pregnant will not be enrolled in this study.
- Any behavioral or psychosocial issue that will interfere with the subject's completion of the program, including an eating disorder will prohibit subjects from participating in this study.
- Subjects cannot participate if they have concurrent membership in a comprehensive weight management program.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00848757
Start Date
March 1 2009
End Date
July 1 2014
Last Update
May 4 2022
Active Locations (1)
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1
Fair Haven Community Health Center
New Haven, Connecticut, United States, 06513