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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Emory University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00743756
First received: August 27, 2008
Last updated: April 9, 2010
Last verified: April 2010
History of Changes
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With T2Dm

Resource links provided by NLM:

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
Experimental: 1
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
Experimental: 2
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:

  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.
  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: Guillermo Umpierrez, Emory University School of Medicine
ClinicalTrials.gov Identifier: NCT00743756     History of Changes
Other Study ID Numbers: 1404-2005
Study First Received: August 27, 2008
Last Updated: April 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
obesity
diabetes
endothelial function
insulin sensitivity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013