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Free Fatty Acid Induced Insulin Resistance (FFAIR)

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ClinicalTrials.gov Identifier: NCT01229059
Recruitment Status : Unknown
Verified October 2010 by German Diabetes Center.
Recruitment status was:  Recruiting
First Posted : October 27, 2010
Last Update Posted : October 27, 2010
Heinrich-Heine University, Duesseldorf
Information provided by:
German Diabetes Center

Brief Summary:
This study aims to explore time-dependent effects of lipid infusion an intramyocellular lipid metabolites and the induction of impaired insulin signaling.

Condition or disease Intervention/treatment
Insulin Resistance Dietary Supplement: Lipovenös lipid infusion

Detailed Description:
Increased availability of free fatty acids impairs glucose disposal in young healthy humans. Patients with type 2 diabetes have reduced whole body glucose disposal, increased ectopic lipid deposition in skeletal muscle and the liver and impaired mitochondrial function. Recent studies suggest that lipid metabolites such as diacylglycerol (DAG), ceramides and long-chain acyl-coA represent the active mediators inducing insulin resistance. Possible targets are DAG-sensitive Proteinkinase C (PKC θ, PKC ε) which inhibit the insulin signaling cascade and ceramides which interfere with the insulin signaling cascade at Proteinkinase B/AKT. Prior studies raised controvesial evidence, thus, it is yet unclear, whether DAG or ceramides are the primary agents inducig lipid-induced insulin resistance. Therefore, the current study aims to explore the time course of the appearance of intramyocellular lipid compunds during lipid infusion in parallel assessing markers of impaired insulin action.

Study Type : Observational
Estimated Enrollment : 15 participants
Time Perspective: Prospective
Official Title: Assessment of the Time Course of Lipid Induced Insulin Resistance
Study Start Date : March 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Group/Cohort Intervention/treatment
lipid infusion
healthy lean humans before and after lipid infusion
Dietary Supplement: Lipovenös lipid infusion
Lipid enriched infusions will be applied for 2-6 hours.
Other Name: soy oil

Primary Outcome Measures :
  1. intramyocellular lipid metabolites [ Time Frame: after 4 hours lipid infusion ]
    Muscle biopsies are taken before, after 2.5 and 4 hours of lipid infusion

Secondary Outcome Measures :
  1. insulin resistance of glucose uptake and mitochondrial function [ Time Frame: after 4 hours lipid infusion ]
    Mitochondrial function will bes assessed from muscle biopsy samples taken after 4 hours, insulin sensitivity will be assessed from hyperinsulinemic-euglycemic clamps following 4 hours lipid infusion

Biospecimen Retention:   Samples With DNA
muscle biopsies

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy, lean non-diabetic humans

Inclusion Criteria:

  • non-diabetic (OGTT), no family history of diabetes, BMI<30 kg/m2, age: 20-55 years, no medication,

Exclusion Criteria:

  • acute illness within the last 2 weeks, autoimmune diseases, renal insufficiency (creatinine> 1.5 mg/dl), cardiovascular diseases, anemia (Hb< 12g/l), donation of blood within the last 4 weeks before the study, thyroid diseases, pregnancy, smoking, night-shift working (disturbed circadian rhythm), defective coagulation or wound healing, cancer, allergy against soja products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229059

Contact: Michael Roden, MD 00492113382 ext 201 michael.roden@ddz.uni-duesseldorf.de

German Diabetes Center Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Michael Roden, MD    00492113382 ext 201    michael.roden@ddz.uni-duesseldorf.de   
Principal Investigator: Michael Roden, MD         
Sponsors and Collaborators
German Diabetes Center
Heinrich-Heine University, Duesseldorf
Principal Investigator: Michael Roden, Prof German Diabetes Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M. Roden, Professor, MD, German Diabetes Center, Düsseldorf
ClinicalTrials.gov Identifier: NCT01229059     History of Changes
Other Study ID Numbers: FFAIR
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: October 2010

Keywords provided by German Diabetes Center:
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs