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Intramuscular Lipid and Insulin Action:Ethnic Aspects (QuEST)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, diet, carbohydrate, insulin

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Outcomes

Primary Outcome Measures

Insulin sensitivity

Secondary Outcome Measures

Weight loss

Full Information

First Posted
July 29, 2008
Last Updated
June 14, 2012
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00726908
Brief Title
Intramuscular Lipid and Insulin Action:Ethnic Aspects
Acronym
QuEST
Official Title
Intramuscular Lipid and Insulin Action:Ethnic Aspects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, diet, carbohydrate, insulin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Low carbohydrate
Intervention Description
43% CHO
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
IVGTT and minimal model
Secondary Outcome Measure Information:
Title
Weight loss
Time Frame
Weight loss over 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara A Gower, PhD
Organizational Affiliation
Univ. Alabama Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27827322
Citation
Morrison SA, Goss AM, Azziz R, Raju DA, Gower BA. Peri-muscular adipose tissue may play a unique role in determining insulin sensitivity/resistance in women with polycystic ovary syndrome. Hum Reprod. 2017 Jan;32(1):185-192. doi: 10.1093/humrep/dew279. Epub 2016 Nov 8.
Results Reference
derived
PubMed Identifier
25527677
Citation
Gower BA, Goss AM. A lower-carbohydrate, higher-fat diet reduces abdominal and intermuscular fat and increases insulin sensitivity in adults at risk of type 2 diabetes. J Nutr. 2015 Jan;145(1):177S-83S. doi: 10.3945/jn.114.195065. Epub 2014 Dec 3.
Results Reference
derived
PubMed Identifier
23616149
Citation
Gower BA, Pollock NK, Casazza K, Clemens TL, Goree LL, Granger WM. Associations of total and undercarboxylated osteocalcin with peripheral and hepatic insulin sensitivity and beta-cell function in overweight adults. J Clin Endocrinol Metab. 2013 Jul;98(7):E1173-80. doi: 10.1210/jc.2013-1203. Epub 2013 Apr 24. Erratum In: J Clin Endocrinol Metab. 2016 May;101(5):2265.
Results Reference
derived
PubMed Identifier
23155695
Citation
Ellis AC, Casazza K, Chandler-Laney P, Gower BA. Higher postprandial serum ghrelin among African-American girls before puberty. J Pediatr Endocrinol Metab. 2012;25(7-8):691-6. doi: 10.1515/jpem-2012-0081.
Results Reference
derived
PubMed Identifier
22481313
Citation
Ellis AC, Chandler-Laney P, Casazza K, Goree LL, Gower BA. Effects of habitual diet on ethnic differences in serum total ghrelin. Endocrine. 2012 Oct;42(2):359-65. doi: 10.1007/s12020-012-9667-2. Epub 2012 Apr 7.
Results Reference
derived
PubMed Identifier
21593507
Citation
Goree LL, Chandler-Laney P, Ellis AC, Casazza K, Granger WM, Gower BA. Dietary macronutrient composition affects beta cell responsiveness but not insulin sensitivity. Am J Clin Nutr. 2011 Jul;94(1):120-7. doi: 10.3945/ajcn.110.002162. Epub 2011 May 18.
Results Reference
derived

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Intramuscular Lipid and Insulin Action:Ethnic Aspects

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