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Sponsored by: |
Medical University of Graz |
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Information provided by: | Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT00708266 |
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 In the visit V1, complete medical examination will be performed and blood samples will be withdrawn to check overall conditions of the healthy volunteers.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 |
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Obesity Type 2 Diabetes Mellitus |
Device: Openflow microperfusion catheter Dietary Supplement: Intralipid 20% Other: 0.9% Saline Solution |
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 |
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 |
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V2: Placebo Comparator
28 hours continuous saline venous infusion.
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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.
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V3: Experimental
28 hours continuous lipid-heparin venous infusion.
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Austria, Steiermark | |
Medical University Graz - Clinical Research Center | |
Graz, Steiermark, Austria, A-8010 |
Principal Investigator: | Thomas R. Pieber, M.D. | Medical University Graz, Graz, Austria |
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 |
Obesity Diabetes Non-esterified fatty acids Cytokines |
Inflammation Subcutaneous fat Adipose tissue |
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 |