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
  Purpose

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.


Condition Intervention
Obesity
Insulin Resistance
Dietary Supplement: test meals with various fatty acid compositions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Skeletal Muscle Lipid Metabolism and Insulin Sensitivity: Can Dietary Fatty Acid Composition Modulate Muscle Lipid Storage?

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: October 2008
Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saturated fatty acid test meal Dietary Supplement: test meals with various fatty acid compositions
Three different milkshakes with a U13C palmitate tracer added
Experimental: Monounsaturated fatty acid meal Dietary Supplement: test meals with various fatty acid compositions
Three different milkshakes with a U13C palmitate tracer added
Experimental: Polyunsaturated fatty acid meal Dietary Supplement: test meals with various fatty acid compositions
Three different milkshakes with a U13C palmitate tracer added

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466816

Locations
Netherlands
Maastricht University Medical Centre +
Maastricht, Limburg, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Ellen E Blaak, PhD, Prof Maastricht University Medical Centre +
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01466816     History of Changes
Other Study ID Numbers: 08-3-030
Study First Received: October 19, 2011
Last Updated: November 3, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Lipid metabolism

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014