Effects of Excess Energy Intake on Metabolic Risk

Insulin Resistance Clinical Trial

— EXCESS  

Official title:

Effects of Excess Energy Intake on Metabolic Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562393
• Other study ID #: EXCESS
• Secondary ID: 427639
• Status: Completed
• Phase: N/A
• First received: November 20, 2007
• Last updated: July 13, 2015
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2015
• Source: Garvan Institute of Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Other:
• Nutritional
Overfeeding high fat diet for 28 days

Locations

Country	Name	City	State
Australia	Garvan Institute of Medical Research	Darlinghurst	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Garvan Institute of Medical Research

Country where clinical trial is conducted

Australia, 

References & Publications (7)

Heilbronn LK, Campbell LV, Xu A, Samocha-Bonet D. Metabolically protective cytokines adiponectin and fibroblast growth factor-21 are increased by acute overfeeding in healthy humans. PLoS One. 2013 Oct 18;8(10):e78864. doi: 10.1371/journal.pone.0078864. e — View Citation

Heilbronn LK, Coster AC, Campbell LV, Greenfield JR, Lange K, Christopher MJ, Meikle PJ, Samocha-Bonet D. The effect of short-term overfeeding on serum lipids in healthy humans. Obesity (Silver Spring). 2013 Dec;21(12):E649-59. doi: 10.1002/oby.20508. Epu — View Citation

Samocha-Bonet D, Campbell LV, Mori TA, Croft KD, Greenfield JR, Turner N, Heilbronn LK. Overfeeding reduces insulin sensitivity and increases oxidative stress, without altering markers of mitochondrial content and function in humans. PLoS One. 2012;7(5):e — View Citation

Samocha-Bonet D, Campbell LV, Viardot A, Freund J, Tam CS, Greenfield JR, Heilbronn LK. A family history of type 2 diabetes increases risk factors associated with overfeeding. Diabetologia. 2010 Aug;53(8):1700-8. doi: 10.1007/s00125-010-1768-y. Epub 2010 — View Citation

Samocha-Bonet D, Tam CS, Campbell LV, Heilbronn LK. Raised circulating fetuin-a after 28-day overfeeding in healthy humans. Diabetes Care. 2014;37(1):e15-6. doi: 10.2337/dc13-1728. — View Citation

Sato K, Samocha-Bonet D, Handelsman DJ, Fujita S, Wittert GA, Heilbronn LK. Serum sex steroids and steroidogenesis-related enzyme expression in skeletal muscle during experimental weight gain in men. Diabetes Metab. 2014 Dec;40(6):439-44. doi: 10.1016/j.d — View Citation

Tam CS, Viardot A, Clément K, Tordjman J, Tonks K, Greenfield JR, Campbell LV, Samocha-Bonet D, Heilbronn LK. Short-term overfeeding may induce peripheral insulin resistance without altering subcutaneous adipose tissue macrophages in humans. Diabetes. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitiviy by hyperinsulinemic clamp		28-days	No
Secondary	Fat oxidation (whole body RQ and C-14 palmitate), mitochondrial function		28-days	No