Effects of Excess Energy Intake on Metabolic Risk (EXCESS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Jerry Greenfield, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00562393
First received: November 20, 2007
Last updated: July 13, 2015
Last verified: July 2015
  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

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

Primary Outcome Measures:
  • Insulin sensitiviy by hyperinsulinemic clamp [ Time Frame: 28-days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fat oxidation (whole body RQ and C-14 palmitate), mitochondrial function [ Time Frame: 28-days ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Overfeeding
4 weeks of 1250 kcal added daily
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00562393

Locations
Australia, New South Wales
Garvan Institute of Medical Research
Darlinghurst, New South Wales, Australia, 2010
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

Publications:

Responsible Party: Dr Jerry Greenfield, Head of Endocrinology Department St Vincent's Hospital Sydney, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT00562393     History of Changes
Other Study ID Numbers: EXCESS, 427639
Study First Received: November 20, 2007
Last Updated: July 13, 2015
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on July 30, 2015