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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00431665
First received: February 5, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Elevated Plasma-Free-Fatty-Acids on Renal Hemodynamic Parameters

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   19 Years to 35 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00431665     History of Changes
Other Study ID Numbers: OPHT-070699
Study First Received: February 5, 2007
Last Updated: February 5, 2007
Health Authority: Austria: Agency for Health and Food Safety

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

Additional relevant MeSH terms:
Heparin
Somatostatin
Omega-N-Methylarginine
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013