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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00743756

Enrollment

Registered

2008-08-29

Start date

2006-04-30

Completion date

2009-12-31

Last updated

2014-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Obesity

Keywords

obesity, diabetes, endothelial function, insulin sensitivity

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), 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

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.

Interventions

DIETARY_SUPPLEMENThome-delivered meals

3 diabetic meals per day, 7 days per week for 12 months

BEHAVIORALdiabetes education for 12 months

subjects in this group received diabetes education for 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Weight Loss in the elderly african american population	6 months to 1 year

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026