Lipids and Insulin Sensitivity

Obesity Clinical Trial

Official title:

Skeletal Muscle Lipid Metabolism and Insulin Sensitivity: Can Dietary Fatty Acid Composition Modulate Muscle Lipid Storage?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466816
• Other study ID #: 08-3-030
• Status: Completed
• Phase: N/A
• First received: October 19, 2011
• Last updated: November 3, 2011
• Start date: October 2008
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle towards less accumulation of lipid metabolites and an improved insulin sensitivity.

Objective:

1. The contribution of dietary vs endogenous fat sources to lipid overflow in the circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant subjects vs obese insulin sensitive controls.

2. The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and storage, fatty acid mediated gene expression and postprandial insulin sensitivity in obese insulin resistant subjects.

Study design: single-blind randomized cross-over trial

Study population: obese males (35-70 years) with or without insulin resistance

Intervention:

1. 1 test meal

2. 3 test meals with a different fatty acid composition

Main study parameters/endpoints:

More insight whether dietary fat quality may modulate circulating lipids and skeletal muscle fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an increased insulin sensitivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• Obese males aged between 35 and 70 years with insulin resistance.

Exclusion Criteria:

• History of type 2 diabetes.

• Liver or kidney failure.

• Diseases in which the live expectation is shorter then 5 years.

• The use of experimental medication.

• Diseases/medication use that may have an influence on the glucose tolerance.

• Not to be able to understand the study information.

• Users of fatty acid supplements including fish oils etc.

• Users of high doses of antioxidant vitamins.

• Athletes.

• People on a diet of people that are planning to lose weight.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• test meals with various fatty acid compositions
Three different milkshakes with a U13C palmitate tracer added

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre +	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute effect of meals with various fatty acid composition on postprandial insulin sensitivity	The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on postprandial insulin sensitivity will be measured during the stable isotope test.	the individual participants will be measured within 8-10 weeks.	No
Primary	Acute effect of meals with various fatty acid composition on forearm muscle fatty acid handling	Using the stable isotope technique, we can differentiate between the metabolic fate of dietary versus endogenous fatty acids	the individual participants will be measured within 8-10 weeks.	No
Secondary	Acute effect of meals with various fatty acid composition on intramuscular fatty acid handling		the individual participants will be measured within 8-10 weeks.	No
Secondary	Acute effect of meals with various fatty acid composition on transcriptional regulation of the fatty acid metabolism in skeletal muscle biopsies	Transcriptional regulation will be measured by means of microarray.	the individual participants will be measured within 8-10 weeks.	No