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Clinical Trials/NCT00562393
NCT00562393CompletedNot Applicable

Effects of Excess Energy Intake on Metabolic Risk

Garvan Institute of Medical Research1 site in 1 country41 target enrollmentStarted: April 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
1
Primary Endpoint
Insulin sensitiviy by hyperinsulinemic clamp

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)
  • •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.

Arms & Interventions

Overfeeding

Experimental

4 weeks of 1250 kcal added daily

Intervention: Nutritional (Other)

Outcomes

Primary Outcomes

Insulin sensitiviy by hyperinsulinemic clamp

Time Frame: 28-days

Secondary Outcomes

  • Fat oxidation (whole body RQ and C-14 palmitate), mitochondrial function(28-days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Jerry Greenfield

Head of Endocrinology Department St Vincent's Hospital Sydney

Garvan Institute of Medical Research

Study Sites (1)

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