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

March 15, 2013 updated by: Jamy Ard, MD, University of Alabama at Birmingham
The purpose of this study is to determine if what you eat affets your insulin sensitivity when you lose a small amount of weight

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham Nutrition Sciences Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin Sensitivity
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F040719005
  • 1K23DK068223-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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