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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00599040
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : March 18, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)
Study Start Date : September 2005
Primary Completion Date : December 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

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 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013

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