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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00562393




Registration number
NCT00562393
Ethics application status
Date submitted
20/11/2007
Date registered
22/11/2007
Date last updated
14/07/2015

Titles & IDs
Public title
Effects of Excess Energy Intake on Metabolic Risk
Scientific title
Effects of Excess Energy Intake on Metabolic Risk
Secondary ID [1] 0 0
427639
Secondary ID [2] 0 0
EXCESS
Universal Trial Number (UTN)
Trial acronym
EXCESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin Resistance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nutritional

Experimental: Overfeeding - 4 weeks of 1250 kcal added daily


Other interventions: Nutritional
Overfeeding high fat diet for 28 days
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Insulin sensitiviy by hyperinsulinemic clamp
Timepoint [1] 0 0
28-days
Secondary outcome [1] 0 0
Fat oxidation (whole body RQ and C-14 palmitate), mitochondrial function
Timepoint [1] 0 0
28-days

Eligibility
Key inclusion criteria
- Sedentary (<60 min formal exercise per week)

- Aged 20-65 years
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Garvan Institute of Medical Research - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00562393
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonie K Heilbronn, PhD
Address 0 0
Garvan Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00562393