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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 goals of reducing disability and deaths due to chronic disease.

Official Title
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Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With T2Dm

Conditions
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Obesity, Diabetes

Intervention / Treatment
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* Dietary Supplement: home-delivered meals
* Dietary Supplement: home-delivered meals
* Behavioral: diabetes education for 12 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>A total of 20 African-American patients with type 2 diabetes will be randomized to receive home-delivered meals for twelve consecutive months. In addition, the subjects received diabetes education at every visit (8 clinic visits and 8 phone calls) | Dietary Supplement: home-delivered meals<br>* 3 diabetic meals per day, 7 days per week for 12 months<br>|
| Experimental: 2<br>A total of 20 African-American patients with type 2 diabetes will be randomized to receive home-delivered meals for six consecutive months. In addition, the subjects received diabetes education for up to twelve months(8 clinic visits and 8 phone calls) | Dietary Supplement: home-delivered meals<br>* diabetic meals 3 times per day, 7 days a week for six months<br>|
| Other: 3<br>20 subjects received 12 months of diabetes education (8 clinic visits and 8 phone calls) | Behavioral: diabetes education for 12 months<br>* subjects in this group received diabetes education for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss in the elderly african american population |  | 6 months to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity |  | 6 months to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, diabetes, endothelial function, insulin sensitivity