Status:
TERMINATED
Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With Type 2 Diabetes Mellitus (DM)
Lead Sponsor:
Emory University
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
65-85 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the impact of home-delivered Medical Nutrition Therapy on clinical outcomes for persons with diabetes. The primary outcomes of this studies include A1c (A1C), bl...
Detailed Description
Data collected as a result of this project will be evaluated in aggregate to demonstrate the potential impacts on health and medical costs available through this type of intervention, with long-term g...
Eligibility Criteria
Inclusion
- African-American subjects
- Males or females 65 - 85 years of age
- Body mass index (BMI) equal to or greater than 30 kg/m2
- Fasting blood glucose less than 300 mg/dL and HbA1c less than 9.0%
- Ability to understand and be willing to adhere to the study protocol
- A known history of type 2 diabetes mellitus greater than 3 months, receiving either diet alone or oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
Exclusion
- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state.
- Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine greater than 3.0 mg/dL.
- Mental condition rendering the subject unable to understand the scope of the study.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00743756
Start Date
April 1 2006
End Date
December 1 2009
Last Update
June 10 2014
Active Locations (1)
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1
Grady Health System
Atlanta, Georgia, United States, 30303