NCT00726908

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable obesity

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

April 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

2.7 years

First QC Date

July 29, 2008

Last Update Submit

June 14, 2012

Conditions

Obesity

Keywords

Obesitydietcarbohydrateinsulin

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    IVGTT and minimal model

Secondary Outcomes (1)

  • Weight loss

    Weight loss over 8 weeks

Interventions

Low carbohydrateDIETARY_SUPPLEMENT

43% CHO

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (6)

  • 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.

    PMID: 27827322DERIVED

  • 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.

    PMID: 25527677DERIVED

  • 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.

    PMID: 23616149DERIVED

  • 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.

    PMID: 23155695DERIVED

  • 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.

    PMID: 22481313DERIVED

  • 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.

    PMID: 21593507DERIVED

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Barbara A Gower, PhD

    Univ. Alabama Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2008

First Posted

August 1, 2008

Study Start

April 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

US(1)