The Influence of Fatty-Acids on Systemic and Subcutaneous Cytokines

NCT00708266 | Completed

• 1 other identifier: TNF4
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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 In the visit V1, complete medical examination will be performed and blood samples will be withdrawn to check overall conditions of the healthy volunteers.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.

Conditions

Obesity; Type 2 Diabetes Mellitus

Keywords

Obesity; Diabetes; Non-esterified fatty acids; Cytokines; Inflammation; Subcutaneous fat; Adipose tissue

Outcome Measures

Primary Outcomes (1)

• Concentrations of IL-6 measured in effluent samples from subcutaneous tissue.

  24 hours of interstitial fluid sampling

Secondary Outcomes (2)

• Concentrations of all other cytokines measured in effluent samples from subcutaneous tissue.

  24 hours of interstitial fluid sampling.

• Cytokine concentrations measured in serum samples.

  24 hours sampling during the experiment

Study Arms (2)

V2

PLACEBO COMPARATOR

28 hours continuous saline venous infusion.

Device: Openflow microperfusion catheter; Other: 0.9% Saline Solution

V3

EXPERIMENTAL

28 hours continuous lipid-heparin venous infusion.

Device: Openflow microperfusion catheter; Dietary Supplement: Intralipid 20%

Interventions

Openflow microperfusion catheter DEVICE

Macro-perforated, double lumen catheter used to withdraw interstitial fluid samples from different tissues.

Also known as: No other names registered.

V2; V3

Intralipid 20% DIETARY_SUPPLEMENT

Lipid emulsion used in clinical practice as supplementary intravenous nutrition. 28 hours venous infusion during the "treatment" study visits.

Also known as: Liposyn

V3

0.9% Saline Solution OTHER

0.9% sodium chloride solution, used in clinical practice for venous hydration. 28 hours infusion during the "control" study visits.

Also known as: - Saline, - 0.9% Sodium Chloride

V2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz - Clinical Research Center

Graz, Styria, A-8010, Austria

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus; Inflammation

Interventions

safflower oil, soybean oil, lecithin emulsion; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Thomas R. Pieber, M.D.

  Medical University Graz, Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 2, 2008
• Study Start: February 1, 2007
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: July 2, 2008

Record last verified: 2008-06

Locations

AU (1)