Effect of Furosemide on Obesity-induced Glomerular Hyperfiltration - Full Text View

Sponsor:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00962286

Purpose

Background: Obesity is associated with a high prevalence of chronic kidney disease. The glomerular hyperfiltration associated with obesity may play a role in the pathogenesis of obesity associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological means may slow down the development and progression of chronic renal failure. The investigators have previously shown that acetazolamide, a proximally acting diuretic that activates TGF by increasing solute delivery to the macula densa, abates glomerular hyperfiltration. The present study was designed to test the hypothesis that this decrease in hyperfiltration is specific to acetazolamide and not due to a non specific diuretic effect. The aim of the present study is to evaluate the effects of the administration of furosemide p.o. to subjects with severe obesity on glomerular hemodynamics.

Methods: Ten obese subjects will participate in the study. They will undergo measurement of glomerular filtration rate (inulin clearance) (GFR), renal plasma flow (RPF) (p-aminohippuric acid clearance), filtration fraction, fractional excretion of lithium (FE LI) and blood pressure, before and after administration of oral furosemide 20 to 40 mg bid for 3 days. The effects of furosemide on glomerular hemodynamics in obese subjects will be compared to the previously studied effects of acetazolamide.

Condition	Intervention
Obesity-induced Hyperfiltration	Drug: Furosemide

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Furosemide

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

change in GFR [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	September 2009
Study Completion Date:	July 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Furosemide, obesity, glomerular hyperfiltration	Drug: Furosemide Subjects will receive 300 mg of lithium carbonate at 22.00 the day before the renal function tests.Intravenous catheters will be placed in each upper limb for infusion of clearance markers and blood sampling.A priming dose of inulin (50 mg/kg) and p-aminohippuric acid (8 mg/kg) will be administered. Thereafter, inulin and p-aminohippuric acid will be infused continuously. A 200-300 ml water load will be given during the first 60-min prime. Subjects will be started on furosemide p.o. 20 mg every 12 hours, starting on day 1 at 15.00 after the renal function studies. Nine doses will be taken, the last dose on day 4 at 7 am. In case the blood pressure does not decrease following 20 mg bid furosemide administration, the study will be repeated after 4 weeks using a dose of 40 mg p.o. bid.

Arms

Assigned Interventions

Experimental: Furosemide, obesity, glomerular hyperfiltration

Drug: Furosemide

Subjects will receive 300 mg of lithium carbonate at 22.00 the day before the renal function tests.Intravenous catheters will be placed in each upper limb for infusion of clearance markers and blood sampling.A priming dose of inulin (50 mg/kg) and p-aminohippuric acid (8 mg/kg) will be administered. Thereafter, inulin and p-aminohippuric acid will be infused continuously. A 200-300 ml water load will be given during the first 60-min prime.

Subjects will be started on furosemide p.o. 20 mg every 12 hours, starting on day 1 at 15.00 after the renal function studies. Nine doses will be taken, the last dose on day 4 at 7 am.

In case the blood pressure does not decrease following 20 mg bid furosemide administration, the study will be repeated after 4 weeks using a dose of 40 mg p.o. bid.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

10 obese men (BMI>30), aged 18 to 55, with glomerular hyperfiltration (creatinine clearance>130 ml/min) will be included in the study.

Exclusion Criteria:

Any of the following conditions:
- Heart failure
- Known allergy to furosemide, inulin or amino-hippurate
- Pharmacologic treatment for hypertension, cardiac disease, diabetes mellitus
- Treatment with corticosteroids or NSAID

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962286

Locations

Israel
Rabin Medical Center
Petach Tikva, Israel

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator:

Boris Zingerman, MD

Rabin Medical Center

More Information

No publications provided

Responsible Party:	Boris Zingerman, MD, Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00962286 History of Changes
Other Study ID Numbers:	OBEFUR
Study First Received:	August 18, 2009
Last Updated:	August 3, 2011
Health Authority:	Israel: Ethics Commission

Keywords provided by Rabin Medical Center:

Furosemide
obesity

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Furosemide
Sodium Potassium Chloride Symporter Inhibitors

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012