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Lipids and Insulin Sensitivity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01466816
Enrollment
10
Registered
2011-11-08
Start date
2008-10-31
Completion date
2011-08-31
Last updated
2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

Keywords

Lipid metabolism

Brief 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.

Interventions

DIETARY_SUPPLEMENTtest meals with various fatty acid compositions

Three different milkshakes with a U13C palmitate tracer added

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
35 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Acute effect of meals with various fatty acid composition on postprandial insulin sensitivitythe individual participants will be measured within 8-10 weeks.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.
Acute effect of meals with various fatty acid composition on forearm muscle fatty acid handlingthe individual participants will be measured within 8-10 weeks.Using the stable isotope technique, we can differentiate between the metabolic fate of dietary versus endogenous fatty acids

Secondary

MeasureTime frameDescription
Acute effect of meals with various fatty acid composition on intramuscular fatty acid handlingthe individual participants will be measured within 8-10 weeks.
Acute effect of meals with various fatty acid composition on transcriptional regulation of the fatty acid metabolism in skeletal muscle biopsiesthe individual participants will be measured within 8-10 weeks.Transcriptional regulation will be measured by means of microarray.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026