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The Influence of Fatty-Acids on Systemic and Subcutaneous Cytokines (TNF4)
This study has been completed.
Sponsored by: Medical University of Graz
Information provided by: Medical University of Graz
ClinicalTrials.gov Identifier: NCT00708266
  Purpose

This is a mono-center randomized controlled trial to be performed in the Center of Medical Research (ZMF) at Medical University Graz and is composed by one screening visit (V1) and two study visits (V2 and V3). In the visit V1, complete medical examination will be performed and blood samples will be withdrawn to check overall conditions of the healthy volunteers. Those who accomplish the necessary conditions will be enrolled in the trial to receive either saline or lipid-heparin solutions in a randomized, cross-over design during visits V2 and V3. Volunteers will arrive at ZMF after overnight fasting, when two venous catheters will be placed in forearm veins. One venous catheter will be used for continuous infusion of lipid-heparin solution (Intralipid 20%, 40 ml/h, Fresenius Kabi plus Heparin 250U/h, IMMUNO Baxter AG) or saline, and Inulin (Inutest 25%, Fresenius Kabi). The second venous catheter will be used for blood sampling (arterialized venous blood). Subsequently, two open flow microperfusion (OFM) macro-perforated catheters will be inserted in the subcutaneous tissue of abdominal wall for continuous sampling of interstitial fluid. Study visits will last for 28 hours for continuous sampling, with four additional hours for observation after infusion discontinuation, during visits V2 and V3. Concentrations of different cytokines, non-esterified fatty-acids, insulin, glucose, triglycerides and inulin will be retrospectively quantified in the frozen samples.

The primary hypothesis is that cytokine concentrations in subcutaneous tissue and/or in circulation can be modified by lipid-heparin infusion.


Condition Intervention
Obesity
Type 2 Diabetes Mellitus
Device: Openflow microperfusion catheter
Dietary Supplement: Intralipid 20%
Other: 0.9% Saline Solution

MedlinePlus related topics: Blood Thinners Diabetes Infectious Mononucleosis Obesity
Drug Information available for: Sodium chloride Chlorides Lipids Safflower oil
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Open Label, Placebo Control, Crossover Assignment
Official Title: A Mono-Centre Randomized Study to Investigate the Effect of Elevated Plasma Fatty Acid Concentrations on Cytokines in Interstitial Fluid of Subcutaneous Adipose Tissue

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Concentrations of IL-6 measured in effluent samples from subcutaneous tissue. [ Time Frame: 24 hours of interstitial fluid sampling ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Concentrations of all other cytokines measured in effluent samples from subcutaneous tissue. [ Time Frame: 24 hours of interstitial fluid sampling. ] [ Designated as safety issue: No ]
  • Cytokine concentrations measured in serum samples. [ Time Frame: 24 hours sampling during the experiment ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
V2: Placebo Comparator
28 hours continuous saline venous infusion.
Device: Openflow microperfusion catheter
Macro-perforated, double lumen catheter used to withdraw interstitial fluid samples from different tissues.
Other: 0.9% Saline Solution
0.9% sodium chloride solution, used in clinical practice for venous hydration. 28 hours infusion during the "control" study visits.
V3: Experimental
28 hours continuous lipid-heparin venous infusion.
Device: Openflow microperfusion catheter
Macro-perforated, double lumen catheter used to withdraw interstitial fluid samples from different tissues.
Dietary Supplement: Intralipid 20%
Lipid emulsion used in clinical practice as supplementary intravenous nutrition. 28 hours venous infusion during the "treatment" study visits.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent signed before any study activities.
  • Age of 18 years old or above.
  • A body mass index (BMI) within the limits of 18.5 to 24.9 (normal range).

Exclusion Criteria:

  • Any clinical signs of acute or chronic inflammation detectable during study visit 1.
  • Severe acute or chronic diseases (e.g. acute respiratory tract infection, systemic lupus erythematosus, rheumatoid arthritis).
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Use of any vasoactive substances (e.g. anti-hypertensive drugs), immune-suppressant or anti-inflammatory drugs (e.g. corticosteroids, aspirin, other COX2 inhibitors) or anti-coagulation treatment.
  • Diseases of the skin which could interfere with catheter insertion in the abdominal wall.
  • Pregnancy in women subjects.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708266

Locations
Austria, Steiermark
Medical University Graz - Clinical Research Center
Graz, Steiermark, Austria, A-8010
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R. Pieber, M.D. Medical University Graz, Graz, Austria
  More Information

Background information to the study site and investigators  This link exits the ClinicalTrials.gov site

Responsible Party: Medical University Graz ( Thomas R. Pieber )
Study ID Numbers: TNF4
Study First Received: June 27, 2008
Last Updated: June 27, 2008
ClinicalTrials.gov Identifier: NCT00708266  
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
Obesity
Diabetes
Non-esterified fatty acids
Cytokines
Inflammation
Subcutaneous fat
Adipose tissue

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Inflammation
Body Weight
Signs and Symptoms
Infectious Mononucleosis
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009