- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03471117
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
Targeting ADMA With Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Paul J Fadel, PhD
- Phone Number: 8172724653
- Email: Paul.Fadel@uta.edu
Study Locations
-
-
Texas
-
Arlington, Texas, United States, 76010
- Recruiting
- University of Texas at Arlington
-
Contact:
- Paul J Fadel, PhD
- Phone Number: 817-272-4653
- Email: paul.fadel@uta.edu
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern
-
Contact:
- Robert Toto, MD
- Phone Number: 214-648-2744
- Email: Robert.Toto@UTSouthwestern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Allergy to Glitazones
- Myocardial infarction
- Heart failure
- Angina
- History of kidney stones
- Liver disease (abnormal liver enzymes)
- Anemia (hemoglobin <8 g/dl)
- Cancer with current treatment
- Previous organ transplantation
- Immunosuppressant therapy
- Human immunodeficiency virus infection
- Pregnancy or lactating
- Current tobacco use
- Dilantin and oral contraceptive usage due to potential drug interaction with glitazones
- Self-identified history of hypoglycemia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paul J Fadel, PhD, University of Texas at Arlington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CKD-IRB-2016-0005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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