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Free Fatty Acid Induced Insulin Resistance (FFAIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01229059
Recruitment Status : Active, not recruiting
First Posted : October 27, 2010
Last Update Posted : November 6, 2018
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
julia szendrödi, 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.

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Other
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 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Group/Cohort Intervention/treatment
lipid infusion in untrained humans
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

lipid infusion in athletes
endurance trained atheletes
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

  2. muscle glucose flux [ Time Frame: during lipid infusion ]
    glycogen synthesis rate, glucose-6-phosphate

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

For the athletes group additionally:

  • VO2max > 60ml/kg/min for males and VO2max > 45ml/kg/min for females Active in endurance-exercise activities, 3 times a week for at least 2 years Stable level of training for at least 3 months

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 identifier (NCT number): NCT01229059

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German Diabetes Center
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
German Diabetes Center
Heinrich-Heine University, Duesseldorf
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Principal Investigator: Michael Roden, Prof German Diabetes Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: julia szendrödi, MD, PhD, German Diabetes Center Identifier: NCT01229059    
Other Study ID Numbers: FFAIR
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Keywords provided by julia szendrödi, German Diabetes Center:
insulin resistance
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs