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

NCT00743756 | Terminated

• 1 other identifier: 1404-2005
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes

Keywords

obesity; diabetes; endothelial function; insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• Weight Loss in the elderly african american population

  6 months to 1 year

Secondary Outcomes (1)

• Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity

  6 months to 1 year

Study Arms (3)

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

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

3

OTHER

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

Behavioral: diabetes education for 12 months

Interventions

home-delivered meals DIETARY_SUPPLEMENT

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

1

diabetes education for 12 months BEHAVIORAL

subjects in this group received diabetes education for 12 months

3

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Guillermo E Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: April 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

US (1)