Text Size

Effects of Excess Energy Intake on Metabolic Risk (EXCESS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Garvan Institute of Medical Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00562393
First received: November 20, 2007
Last updated: November 21, 2007
Last verified: November 2007
History of Changes
  Purpose

The prevalence of obesity has reached epidemic proportions and is associated with the development of insulin resistance and type 2 diabetes (T2DM). A unifying theme has emerged over the past few years suggesting that lipid oversupply to metabolic organs responsible for glucose regulation leads to insulin resistance. Fitting with this, we and others have shown that increased lipid accumulation within skeletal muscle and/or liver is associated with impaired glucose uptake. However, the underlying mechanisms that mediate changes in muscle lipid metabolism are not yet known. The overall aim of this project is to examine metabolic effects of experimental weight gain in lean and overweight individuals with and without a genetic predisposition to type 2 diabetes. We hypothesise that lean subjects will increase fatty acid oxidation and upregulate mitochondrial oxidative capacity in muscle following overfeeding to protect against body weight gain and insulin resistance, but overweight subjects with a genetic predisposition to T2DM will have a defect in this ability.


Condition Intervention
Insulin Resistance
 Other: Nutritional

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Excess Energy Intake on Metabolic Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Garvan Institute of Medical Research:

Primary Outcome Measures:
  • Insulin sensitiviy by hyperinsulinemic clamp [ Time Frame: 28-days ]

Secondary Outcome Measures:
  • Fat oxidation (whole body RQ and C-14 palmitate), mitochondrial function [ Time Frame: 28-days ]

Estimated Enrollment: 48
Study Start Date: April 2007
Estimated Study Completion Date: December 2008
Intervention Details:
    Other: Nutritional
    Overfeeding high fat diet for 28 days
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sedentary (<60 min formal exercise per week)
  • Aged 20-65 years

Exclusion Criteria:

  • Personal history of diabetes, cardiovascular disease or hypertension
  • Recent weight change (larger than 4kg in the past 3 months)
  • Smoking
  • Regular use of medications, except oral contraceptives
  • Individuals with alcoholism or other substance abuse
  • Pregnancy or lactation, women who are planning to become pregnant or who are not using adequate measures of birth control.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562393

Locations
Australia, New South Wales
Garvan Institute of Medical Research Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Leonie K Heilbronn, PhD     61 2 92958309     l.heilbronn@garvan.org.au    
Principal Investigator: Leonie K Heilbronn, PhD            
Sponsors and Collaborators
Garvan Institute of Medical Research
Investigators
Principal Investigator: Leonie K Heilbronn, PhD Garvan Institute
Principal Investigator: Lesley M Campbell, MBBS Garvan Insititute
  More Information

No publications provided by Garvan Institute of Medical Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00562393     History of Changes
Other Study ID Numbers: EXCESS, 427639
Study First Received: November 20, 2007
Last Updated: November 21, 2007
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013