Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lipids and Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01466816
First received: October 19, 2011
Last updated: November 3, 2011
Last verified: November 2011

October 19, 2011
November 3, 2011
October 2008
August 2010   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]
    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 handling [ Time Frame: the individual participants will be measured within 8-10 weeks. ] [ Designated as safety issue: No ]
    Using the stable isotope technique, we can differentiate between the metabolic fate of dietary versus endogenous fatty acids
Same as current
Complete list of historical versions of study NCT01466816 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    Transcriptional regulation will be measured by means of microarray.
Same as current
Not Provided
Not Provided
 
Lipids and Insulin Sensitivity
Skeletal Muscle Lipid Metabolism and Insulin Sensitivity: Can Dietary Fatty Acid Composition Modulate Muscle Lipid Storage?

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Obesity
  • Insulin Resistance
Dietary Supplement: test meals with various fatty acid compositions
Three different milkshakes with a U13C palmitate tracer added
  • Experimental: Saturated fatty acid test meal
    Intervention: Dietary Supplement: test meals with various fatty acid compositions
  • Experimental: Monounsaturated fatty acid meal
    Intervention: Dietary Supplement: test meals with various fatty acid compositions
  • Experimental: Polyunsaturated fatty acid meal
    Intervention: Dietary Supplement: test meals with various fatty acid compositions
Jans A, Konings E, Goossens GH, Bouwman FG, Moors CC, Boekschoten MV, Afman LA, Müller M, Mariman EC, Blaak EE. PUFAs acutely affect triacylglycerol-derived skeletal muscle fatty acid uptake and increase postprandial insulin sensitivity. Am J Clin Nutr. 2012 Apr;95(4):825-36. doi: 10.3945/ajcn.111.028787. Epub 2012 Feb 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
August 2011
August 2010   (final data collection date for primary outcome measure)

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.
Male
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01466816
08-3-030
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Ellen E Blaak, PhD, Prof Maastricht University Medical Centre +
Maastricht University Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP