Intramuscular Lipid and Insulin Action:Ethnic Aspects (QuEST)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Gower, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00726908
First received: July 29, 2008
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

High levels of the hormone insulin are associated with risk for heart disease and diabetes, and may make it hard to lose weight. The types of food eaten may affect insulin levels. The purpose of this study is to determine if manipulation of dietary carbohydrate content improves insulin sensitivity (Si), augments weight loss, and promotes weight loss maintenance in healthy adults.


Condition Intervention
Obesity
Dietary Supplement: Low carbohydrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Intramuscular Lipid and Insulin Action:Ethnic Aspects

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: IVGTT and minimal model ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight loss [ Time Frame: Weight loss over 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Low carbohydrate
    43% CHO
  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Overweight, age 21-50 years,Women must be premenopausal, Normal glucose tolerance, weight stable for at least 6 months with a weight change no greater than 5 lbs.

Exclusion Criteria:

Exclusion criteria were type 1 or type 2 diabetes, polycystic ovarian disease, BMI <26.5 or weight >300 pounds, weight change >5 pounds in last 6 months, regular exercise >2 hours per week, pregnancy, currently breastfeeding, cholesterol medications, any disorders of glucose or lipid metabolism, use of medication that could affect body composition or glucose metabolism (including oral contraceptives and blood pressure medications), current use of tobacco, use of illegal drugs in last 6 months, history of hypoglycemic episodes, major food allergies or food dislikes, women with inconsistent or absence of monthly menstrual cycles, and a medical history that counter-indicated inclusion in the study.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00726908

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Barbara A Gower, PhD Univ. Alabama Birmingham
  More Information

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara Gower, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00726908     History of Changes
Other Study ID Numbers: F070322005, R01DK067538
Study First Received: July 29, 2008
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Obesity
diet
carbohydrate
insulin

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014