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The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jamy Ard, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00599040
First received: January 10, 2008
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to determine if what you eat affets your insulin sensitivity when you lose a small amount of weight


Condition Intervention Phase
Diabetes
Hypertension
Insulin Resistance
 Behavioral: The DASH diet with weight loss
Behavioral: The DASH diet without weight loss
Behavioral: Dairy diet
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: September 2005
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Weight loss
Weight loss diet focused on the DASH diet
 Behavioral: The DASH diet with weight loss
A reduced calorie diet is provided to participants based on the DASH diet.
Active Comparator: DASH diet
The DASH diet without weight loss
 Behavioral: The DASH diet without weight loss
participants are given a weight maintainenance diet based on the DASH diet
Active Comparator: Diary
Dairy Intervention
 Behavioral: Dairy diet
participants are given a high dairy, reduced calorie diet

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American adults (age ≥ 19)
  • Obese (BMI > or equal to 30 kg/m2)
  • Otherwise generally healthy

Exclusion Criteria:

  • Diagnoses of diabetes
  • Malignancy or other states where weight loss is contraindicated (pregnancy
  • Individuals with high blood pressure on medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599040

Locations
United States, Alabama
University of Alabama at Birmingham Nutrition Sciences Department
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jamy D Ard, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Jamy Ard, MD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00599040     History of Changes
Other Study ID Numbers: F040719005, 1K23DK068223-01
Study First Received: January 10, 2008
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Insulin Resistance
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013