ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Excess Energy Intake on Metabolic Risk (EXCESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00562393
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Jerry Greenfield, Garvan Institute of Medical Research

Brief Summary:
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 or disease Intervention/treatment Phase
Insulin Resistance Other: Nutritional Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Excess Energy Intake on Metabolic Risk
Study Start Date : April 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: Overfeeding
4 weeks of 1250 kcal added daily
Other: Nutritional
Overfeeding high fat diet for 28 days




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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015

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