Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients

Part of paid clinical trials in Arlington, Texas.

Sponsor
The University of Texas at Arlington
Study ID
NCT03471117
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
35 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Pioglitazone — DRUG
    Pioglitazone 15mg daily for 1 month
  • Placebo — OTHER
    Placebo pills for 1 month

Study Details

Chronic kidney disease (CKD) is associated with a higher risk of cardiovascular disease and death. An overactive sympathetic nervous system in CKD patients is one of the major mechanisms increasing the cardiovascular risks in this patient population. Recently, some studies have shown that a drug typically used to improve glucose control (pioglitazone) may also reduce sympathetic nerve activity and improve blood vessel function. The goal of this study is to determine whether a short-term treatment with pioglitazone can reduce sympathetic nerve impulses throughout the body in CKD patients.

Key Dates

Start date
Apr 1, 2018
Status verified
Jun 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Pioglitazone
    The subjects will be given 1 month supply of Pioglitazone pills. Pioglitazone is a class of anti-diabetic drugs called thiazolidinediones that are primarily used in the treatment of type 2 diabetes. The aim of the study is to determine if Pioglitazone also reduces ADMA and sympathetic nerve activity in CKD patients. This drug will be taken orally as a pill or capsule for one month. The dosage is 15 mg/day. This is on the lower dosage side for pioglitazone with the maximum dosage being 45mg/day. The research subjects are not responsible for the cost of the drug or for drug administration costs. The subjects will be verbally instructed to take 1 pill everyday by mouth, for 1 month. In addition, the pill bottle will be labeled with the same instructions.
  • Placebo Comparator: Placebo
    Placebo pills are made of avicel microcrystalline cellulose and magnesium stearate, which are inactive ingredients in the Pioglitazone pills. The placebo pills will be of similar color and appearance as the Pioglitazone pills

Primary Outcome Measure

Muscle sympathetic nerve activity (MSNA) will be reduced after 1 month of treatment with pioglitazone [ Time Frame: 1 month ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Texas at ArlingtonArlingtonTexas76010
Paul J Fadel, PhD
[email protected]
817-272-4653
UT SouthwesternDallasTexas75390
Robert Toto, MD
[email protected]
214-648-2744

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By research site
University of Texas at Arlington· Arlington, TXUT Southwestern· Dallas, TX

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