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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00743756
• Other study ID #: 1404-2005
• Status: Terminated
• Phase: N/A
• First received: August 27, 2008
• Last updated: June 7, 2014
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: June 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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), 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.

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 goals of reducing disability and deaths due to chronic disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

1. African-American subjects

2. Males or females 65 - 85 years of age

3. Body mass index (BMI) equal to or greater than 30 kg/m2

4. Fasting blood glucose less than 300 mg/dL and HbA1c less than 9.0%

5. Ability to understand and be willing to adhere to the study protocol

6. 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:

1. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state.

2. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine greater than 3.0 mg/dL.

3. Mental condition rendering the subject unable to understand the scope of the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Dietary Supplement:
• home-delivered meals
3 diabetic meals per day, 7 days per week for 12 months
• home-delivered meals
diabetic meals 3 times per day, 7 days a week for six months

Behavioral:
• diabetes education for 12 months
subjects in this group received diabetes education for 12 months

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss in the elderly african american population		6 months to 1 year	No
Secondary	Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity		6 months to 1 year	No