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

Sponsor:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00743756

Purpose

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.

Condition	Intervention
Obesity Diabetes	Dietary Supplement: home-delivered meals Behavioral: diabetes education for 12 months

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment
Official Title:	Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With T2Dm

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Dietary Supplements Diets Obesity

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

Weight Loss in the elderly african american population [ Time Frame: 6 months to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity [ Time Frame: 6 months to 1 year ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 3 diabetic meals per day, 7 days per week for 12 months
2: Experimental 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 diabetic meals 3 times per day, 7 days a week for six months
3 20 subjects received 12 months of diabetes education (8 clinic visits and 8 phone calls)	Behavioral: diabetes education for 12 months subjects in this group received diabetes education for 12 months

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.

Eligibility

Ages Eligible for Study:	65 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743756

Locations

United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Guillermo E Umpierrez, MD

Emory University

More Information

No publications provided

Responsible Party:	Emory University School of Medicine ( Guillermo Umpierrez )
Study ID Numbers:	1404-2005
Study First Received:	August 27, 2008
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00743756 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

obesity
diabetes
endothelial function
insulin sensitivity

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009