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

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ClinicalTrials.gov Identifier: NCT00743756
Recruitment Status : Terminated (slow patient enrollment)
First Posted : August 29, 2008
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Dietary Supplement: home-delivered meals Behavioral: diabetes education for 12 months Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With T2Dm
Study Start Date : April 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Weight Loss in the elderly african american population [ Time Frame: 6 months to 1 year ]

Secondary Outcome Measures :
  1. Endothelial Function (assessed by pulse-wave analysis); sympathetic activity; insulin sensitivity [ Time Frame: 6 months to 1 year ]


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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Guillermo Umpierrez, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00743756     History of Changes
Other Study ID Numbers: 1404-2005
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

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