Free Fatty Acid Induced Insulin Resistance (FFAIR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by German Diabetes Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by:
German Diabetes Center
ClinicalTrials.gov Identifier:
NCT01229059
First received: March 20, 2010
Last updated: October 26, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention
Insulin Resistance
Dietary Supplement: Lipovenös lipid infusion

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of the Time Course of Lipid Induced Insulin Resistance

Resource links provided by NLM:


Further study details as provided by German Diabetes Center:

Primary Outcome Measures:
  • intramyocellular lipid metabolites [ Time Frame: after 4 hours lipid infusion ] [ Designated as safety issue: No ]
    Muscle biopsies are taken before, after 2.5 and 4 hours of lipid infusion


Secondary Outcome Measures:
  • insulin resistance of glucose uptake and mitochondrial function [ Time Frame: after 4 hours lipid infusion ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 15
Study Start Date: March 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy, lean non-diabetic humans

Criteria

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
  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: NCT01229059

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

Locations
Germany
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
Investigators
Principal Investigator: Michael Roden, Prof German Diabetes Center
  More Information

No publications provided

Responsible Party: M. Roden, Professor, MD, German Diabetes Center, Düsseldorf
ClinicalTrials.gov Identifier: NCT01229059     History of Changes
Other Study ID Numbers: FFAIR
Study First Received: March 20, 2010
Last Updated: October 26, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by German Diabetes Center:
FFA
insulin resistance
mitochondria

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

ClinicalTrials.gov processed this record on July 20, 2014