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

Tracking Information

First Received Date ^ICMJE

August 27, 2008

Last Updated Date

November 6, 2009

Start Date ^ICMJE

April 2006

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00743756 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Open Label, Parallel Assignment

Condition ^ICMJE

Obesity
Diabetes

Intervention ^ICMJE

Dietary Supplement: home-delivered meals
Behavioral: diabetes education for 12 months

Study Arms / Comparison Groups

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)
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)
Other: 20 subjects received 12 months of diabetes education (8 clinic visits and 8 phone calls)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

65 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00743756

Responsible Party

Guillermo Umpierrez, Emory University School of Medicine

Study ID Numbers ^ICMJE

1404-2005

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Guillermo E Umpierrez, MD

Emory University

Information Provided By

Emory University

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP