Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients

ConditionChronic Kidney Diseases

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age35-70

SponsorThe University of Texas at Arlington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

CKD patients classified as Stage 3 and 4 of National Kidney Foundation Classification with estimated glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) formula based on serum creatinine, age, gender, and race.

Men and women 35 to 70 years of age

Disqualifiers

Allergy to Glitazones

Myocardial infarction

Heart failure

Angina

Trial design

Design model

Crossover

Treatments tested in this trial

Pioglitazone
Drug
Pioglitazone 15mg daily for 1 month
Placebo
Other intervention
Placebo pills for 1 month

Treatment groups

28 Participants

are divided into 2 treatment groups

Group A: PioglitazoneActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Muscle sympathetic nerve activity (MSNA) will be reduced after 1 month of treatment with pioglitazone

Multiunit postganglionic MSNA will be recorded using standard microneurographic techniques. Briefly, a unipolar tungsten microelectrode will be inserted into the peroneal nerve near the fibular head of the leg. Neural signals will be amplified, filtered (bandwidth, 700-2,000 Hz), rectified, and integrated (time constant, 0.1 s) to obtain mean voltage neurograms.

Time frame

1 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas at Arlington

Lead sponsor

University of Texas, Southwestern Medical Center at Dallas

Collaborator

Source ClinicalTrials.gov

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