Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
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|ClinicalTrials.gov Identifier: NCT03471117|
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : November 13, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases||Drug: Pioglitazone Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||This will be a randomized, placebo-controlled crossover design study|
|Masking Description:||Subjects will either receive placebo or pioglitazone pills in a randomized order. Placebo pills will be sugar pills of same shape and size as the pioglitazone pills. The randomization for study drugs will be carried out by research personnel. All treatments will be encapsulated so that pills are identical and patients cannot identify the treatment arm.|
|Primary Purpose:||Basic Science|
|Official Title:||Targeting ADMA With Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
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.
Pioglitazone 15mg daily for 1 month
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
Placebo pills for 1 month
- Muscle sympathetic nerve activity (MSNA) will be reduced after 1 month of treatment with pioglitazone [ Time Frame: 1 month ]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.
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): NCT03471117
|Contact: Paul J Fadel, PhD||8172724653||Paul.Fadel@uta.edu|
|United States, Texas|
|University of Texas at Arlington||Recruiting|
|Arlington, Texas, United States, 76010|
|Contact: Paul J Fadel, PhD 817-272-4653 firstname.lastname@example.org|
|Dallas, Texas, United States, 75390|
|Contact: Robert Toto, MD 214-648-2744 Robert.Toto@UTSouthwestern.edu|
|Principal Investigator:||Paul J Fadel, PhD||University of Texas at Arlington|