Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
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

January 10, 2008
March 15, 2013
September 2005
December 2009   (final data collection date for primary outcome measure)
Insulin Sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00599040 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)
The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diabetes
  • Hypertension
  • Insulin Resistance
  • Behavioral: The DASH diet with weight loss
    A reduced calorie diet is provided to participants based on the DASH diet.
  • Behavioral: The DASH diet without weight loss
    participants are given a weight maintainenance diet based on the DASH diet
  • Behavioral: Dairy diet
    participants are given a high dairy, reduced calorie diet
  • Active Comparator: Weight loss
    Weight loss diet focused on the DASH diet
    Intervention: Behavioral: The DASH diet with weight loss
  • Active Comparator: DASH diet
    The DASH diet without weight loss
    Intervention: Behavioral: The DASH diet without weight loss
  • Active Comparator: Diary
    Dairy Intervention
    Intervention: Behavioral: Dairy diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
December 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00599040
F040719005, 1K23DK068223-01
Yes
Jamy Ard, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Jamy D Ard, MD University of Alabama at Birmingham
University of Alabama at Birmingham
March 2013

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