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Thiazolidinedione

Pioglitazone + Weight Loss for Kidney Stones

Phase 4
Recruiting
Led By Khashayar Sakhaee, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial will compare the effects of a weight loss program with or without the drug Pio on obese people with type 2 diabetes.

Who is the study for?
This trial is for adults over 21 with a specific type of kidney stone (over 90% uric acid) who are overweight but weigh less than 165 kg. They should have normal kidney function and not be on certain medications or have conditions like chronic diarrhea, heart failure, or uncontrolled diabetes.Check my eligibility
What is being tested?
The study tests the effects of Pioglitazone (a diabetes drug), weight loss, or both combined on patients with uric acid kidney stones. Participants will follow a fixed diet and be monitored through various medical assessments over a period of 24 weeks.See study design
What are the potential side effects?
Pioglitazone may cause side effects such as liver issues, swelling in legs (pedal edema), heart failure symptoms worsening if pre-existing, and potential increased risk of bladder cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urine pH
Secondary outcome measures
Uric acid
Urine Ammonium/Net Acid Excretion
Urine Net Acid Excretion/Sulphate

Trial Design

3Treatment groups
Experimental Treatment
Group I: Weight Loss, BehavioralExperimental Treatment1 Intervention
Weight loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.
Group II: Pioglitazone Drug (including Placebo)Experimental Treatment1 Intervention
45 mg/day- one pioglitazone tablet once daily throughout the 24 weeks of the study
Group III: Pioglitazone + Weight LossExperimental Treatment1 Intervention
Pioglitazone 45 mg/day + Weight Loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Weight Loss
2008
Completed Phase 3
~1460
Pioglitazone 45 mg
2000
Completed Phase 4
~960

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,757 Total Patients Enrolled
5 Trials studying Kidney Stones
652 Patients Enrolled for Kidney Stones
Khashayar Sakhaee, MDPrincipal Investigator - UTSW
Children's Medical Center of Dallas, The University of Texas Southwestern Medical Center At Dallas, UT Southwestern Medical Center-Zale Lipshy Campus
Shiraz University Of Medical Sci & Hlth Serv (Medical School)
Vet Affairs Medical Center (Residency)
4 Previous Clinical Trials
178 Total Patients Enrolled

Media Library

Pioglitazone (Thiazolidinedione) Clinical Trial Eligibility Overview. Trial Name: NCT04370093 — Phase 4
Kidney Stones Research Study Groups: Pioglitazone Drug (including Placebo), Weight Loss, Behavioral, Pioglitazone + Weight Loss
Kidney Stones Clinical Trial 2023: Pioglitazone Highlights & Side Effects. Trial Name: NCT04370093 — Phase 4
Pioglitazone (Thiazolidinedione) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04370093 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any previous research on utilizing Weight Loss as a therapeutic intervention?

"Currently, 31 medical studies involving Weight loss are still ongoing with 4 of them in the advanced Phase 3. These trials can found at 69 distinct sites around the world, including Lausanne, Vaud."

Answered by AI

Is the efficacy of weight loss interventions endorsed by the FDA?

"As this is a phase 4 trial, indicating that the treatment has already been approved for use in clinical settings, the safety score of weight loss was rated with a 3."

Answered by AI

Is there any availability for enrolment in this experiment?

"That is correct. According to the information on clinicaltrials.gov, this research project commenced recruiting participants on October 17th 2019 and has most recently been updated on May 19th 2022. This trial requires 54 volunteers from one site to participate in the study."

Answered by AI

Are there any criteria for selecting participants for this clinical investigation?

"This medical trial can accept 54 applicants, provided they have elevated uric acid and are between 21-99 years of age."

Answered by AI

How has Weight Loss been demonstrated to be beneficial in treating medical conditions?

"Weight loss is frequently prescribed to manage diabetes, as well as other ailments like diabetic neuralgia and lifestyle modifications."

Answered by AI

Are participants aged over 30 eligible for this trial?

"To be considered for this medical trial, participants must have ages ranging from 21 to 99. There are 25 studies available for those younger than 18 and 273 specifically tailored towards elderly patients."

Answered by AI

How many individuals are taking part in this experiment?

"Indeed, according to clinicaltrials.gov, this experiment is presently recruiting participants. Its initial posting was on October 17th 2019 with the latest update being May 19th 2022; 54 people are sought for enrolment at a single location."

Answered by AI
~1 spots leftby Jun 2024