Back to resultsThe DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans) (DINE)
Primary Purpose
Diabetes, Hypertension, Insulin Resistance
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
The DASH diet with weight loss
The DASH diet without weight loss
Dairy diet
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes
Eligibility 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.
Sites / Locations
- University of Alabama at Birmingham Nutrition Sciences Department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Weight loss
DASH diet
Diary
Arm Description
Weight loss diet focused on the DASH diet
The DASH diet without weight loss
Dairy Intervention
Outcomes
Primary Outcome Measures
Insulin Sensitivity
Secondary Outcome Measures
Full Information
NCT ID
NCT00599040
First Posted
January 10, 2008
Last Updated
March 15, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00599040
Brief Title
The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)
Acronym
DINE
Official Title
The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Insulin Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight loss
Arm Type
Active Comparator
Arm Description
Weight loss diet focused on the DASH diet
Arm Title
DASH diet
Arm Type
Active Comparator
Arm Description
The DASH diet without weight loss
Arm Title
Diary
Arm Type
Active Comparator
Arm Description
Dairy Intervention
Intervention Type
Behavioral
Intervention Name(s)
The DASH diet with weight loss
Intervention Description
A reduced calorie diet is provided to participants based on the DASH diet.
Intervention Type
Behavioral
Intervention Name(s)
The DASH diet without weight loss
Intervention Description
participants are given a weight maintainenance diet based on the DASH diet
Intervention Type
Behavioral
Intervention Name(s)
Dairy diet
Intervention Description
participants are given a high dairy, reduced calorie diet
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamy D Ard, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Nutrition Sciences Department
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)
We'll reach out to this number within 24 hrs