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Effect of Elevated Plasma-Free-Fatty-Acids on Renal Hemodynamic Parameters

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00431665
First Posted: February 6, 2007
Last Update Posted: February 6, 2007
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.
Information provided by:
Medical University of Vienna
  Purpose

Type 2 diabetes is frequently associated with elevation of plasma-free fatty acids (FFA). Studies indicate that elevation of plasma-FFA induces insulin resistance and also causes endothelial dysfunction as well as hemodynamic changes which are supposed to be involved in the pathogenesis of diabetic vascular disorders.

Glomerular hyperfiltration, which is associated with glomerular hypertension and hypertrophy, a common finding in the early course of type 1 diabetes as well as type 2 diabetes, plays an important role in the development and progression of diabetic nephropathy. These hemodynamic changes are not well understood, but are most likely induced by dilatation of the (precapillary) glomerular arteriole.

In humans the hemodynamic effect of FFAs has so far been investigated locally in brachial and femoral arteries and recently in the eye and skin, where FFAs induced a pronounced increase in blood flow probably due to a local decrease in vascular resistance.

The aim of the present study is to characterise the hemodynamic effects of FFAs in the kidney. In addition we want to test the hypothesis that FFA-induced changes are mediated via endothelial derived nitric oxide (NO). The results of this study could provide information to what extent elevated FFA-plasma levels contribute to hyperfiltration in the early course of diabetes mellitus. The measurements will be done at baseline and during 4 hour infusion of a triglyceride or placebo infusion, combined with heparin.


Condition Intervention
Renal Circulation Renal Plasma Flow Glomerular Filtration Rate Fatty Acids, Nonesterified Drug: NG-monomethyl-L-Arginine (L-NMMA) Drug: triglycerides (Intralipid 20%) Drug: heparin Drug: somatostatin Drug: insulin Drug: glucose Drug: inulin Drug: paraamino hippurate (PAH)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Elevated Plasma-Free-Fatty-Acids on Renal Hemodynamic Parameters

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Renal plasma flow
  • Glomerular filtration rate

Estimated Enrollment: 9
Study Start Date: July 1999
Estimated Study Completion Date: June 2000
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men aged between 19 and 35 years
  • Body mass index between 15th and 85th percentile (Must et al. 1991)
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00431665


Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Michael Roden, MD Department of Internal Medicine III, Medical University of Vienna
  More Information

ClinicalTrials.gov Identifier: NCT00431665     History of Changes
Other Study ID Numbers: OPHT-070699
First Submitted: February 5, 2007
First Posted: February 6, 2007
Last Update Posted: February 6, 2007
Last Verified: February 2007

Keywords provided by Medical University of Vienna:
Renal Plasma Flow
Glomerular Filtration Rate
Free fatty acids

Additional relevant MeSH terms:
Heparin
Somatostatin
Soybean oil, phospholipid emulsion
omega-N-Methylarginine
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Enzyme Inhibitors