NCT00599040

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

4.3 years

First QC Date

January 10, 2008

Last Update Submit

March 15, 2013

Conditions

DiabetesHypertensionInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    8 weeks

Study Arms (3)

Weight loss

ACTIVE COMPARATOR

Weight loss diet focused on the DASH diet

Behavioral: The DASH diet with weight loss

DASH diet

ACTIVE COMPARATOR

The DASH diet without weight loss

Behavioral: The DASH diet without weight loss

Diary

ACTIVE COMPARATOR

Dairy Intervention

Behavioral: Dairy diet

Interventions

The DASH diet with weight lossBEHAVIORAL

A reduced calorie diet is provided to participants based on the DASH diet.

Weight loss
The DASH diet without weight lossBEHAVIORAL

participants are given a weight maintainenance diet based on the DASH diet

DASH diet
Dairy dietBEHAVIORAL

participants are given a high dairy, reduced calorie diet

Diary

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diagnoses of diabetes
  • Malignancy or other states where weight loss is contraindicated (pregnancy
  • Individuals with high blood pressure on medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham Nutrition Sciences Department

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesHyperinsulinism

Study Officials

  • Jamy D Ard, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 23, 2008

Study Start

September 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

US(1)