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OpenTrials
Completed

NCT Number: NCT01466816

Lipids and Insulin Sensitivity

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.

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Key information

Age range

35 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre +

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

test meals with various fatty acid compositions

Dietary Supplement

Three different milkshakes with a U13C palmitate tracer added

Primary outcomes

  1. Acute effect of meals with various fatty acid composition on postprandial insulin sensitivity

    Time frame: the 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.

  2. Acute effect of meals with various fatty acid composition on forearm muscle fatty acid handling

    Time frame: the 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 outcomes

  1. Acute effect of meals with various fatty acid composition on intramuscular fatty acid handling

    Time frame: the individual participants will be measured within 8-10 weeks.

  2. Acute effect of meals with various fatty acid composition on transcriptional regulation of the fatty acid metabolism in skeletal muscle biopsies

    Time frame: the individual participants will be measured within 8-10 weeks.

    Transcriptional regulation will be measured by means of microarray.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Nov 8, 2011
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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