Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With Type 2 Diabetes Mellitus (DM)

Stopped early · Not applicable

Conditions studied: Obesity, Diabetes

In brief

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), blood glucose, blood pressure, Body Mass Index, lipid levels and other measures of disease progression and management as well as costs of medical care provided throughout the intervention period.

Key facts

Study ID

NCT00743756

Run by

Emory University

People needed

38

Starts

2006-04-01

Expected to finish

2009-12-01

Last updated by the study team

2014-06-10

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Grady Health System — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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