Pioglitazone for Gastroparesis

(PIOGAS Trial)

Overseen By Guillermo Barahona, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Johns Hopkins University

Must not be taking: Narcotics, Estradiol, Warfarin, others

Disqualifiers: Pregnancy, Diabetes, Bladder cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the drug pioglitazone can alleviate symptoms in people with idiopathic gastroparesis. Gastroparesis prevents the stomach from emptying food properly, leading to nausea, vomiting, bloating, and stomach pain. Individuals diagnosed with gastroparesis who continue to experience these symptoms may be suitable candidates for this trial. The study will last eight weeks, during which participants will take pioglitazone to assess its effect on their symptoms. As an Early Phase 1 trial, this research seeks to understand how pioglitazone functions in people, offering participants the opportunity to contribute to groundbreaking medical insights.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including estradiol, ethynyl estradiol, mestranol, pazopanib, warfarin, digoxin, atorvastatin, ranitidine, gemfibrozil, fexofenadine, and midazolam. If you are on any of these, you would need to discontinue them to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that pioglitazone is generally safe for people. One study with very sick children found that pioglitazone was well-tolerated, meaning it didn't cause harmful side effects. For adults with type 2 diabetes, pioglitazone has been used safely for many years, suggesting it might also be safe for other health issues. Although pioglitazone is being tested here for gastroparesis, which differs from diabetes, its safety record in other conditions is reassuring. However, this remains an early trial, so more research is needed to confirm its safety for gastroparesis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for gastroparesis?

Most treatments for gastroparesis focus on relieving symptoms like nausea and vomiting, generally using medications such as metoclopramide or erythromycin. But Pioglitazone works differently, targeting insulin resistance, which is thought to play a role in gastroparesis by affecting stomach motility. Researchers are excited because Pioglitazone, traditionally used for diabetes, might improve gastric emptying by enhancing insulin sensitivity, potentially offering a new approach to managing gastroparesis beyond symptom relief.

What evidence suggests that pioglitazone might be an effective treatment for gastroparesis?

Researchers are investigating whether pioglitazone, the treatment studied in this trial, can alleviate symptoms of idiopathic gastroparesis, a condition where the stomach struggles to process food. While direct evidence of its effectiveness for this condition remains limited, pioglitazone is already used to treat type 2 diabetes. It increases the body's sensitivity to insulin, which might also relieve gastroparesis symptoms. Early results from diabetes studies have shown that pioglitazone is effective in other areas, suggesting promise for its potential use in gastroparesis. However, further research is necessary to confirm its benefits for this specific condition. ^{2 3 6 7 8}

Who Is on the Research Team?

Glenn J Treisman, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults with Idiopathic Gastroparesis, confirmed by gastric emptying tests, can join this trial. They must have ongoing symptoms like nausea and vomiting. Pregnant or nursing individuals, those under 18, with a history of bladder cancer or significant liver disease, recent severe heart issues, uncontrolled other diseases that could explain symptoms, previous upper GI tract surgery or diabetes are excluded.

Inclusion Criteria

Females will be required to use adequate contraceptive methods during study participation as determined by the Principal Investigator and the study team members

I experience ongoing symptoms like nausea, vomiting, bloating, and abdominal pain due to gastroparesis.

My symptoms are not due to conditions like stomach ulcers or esophagus issues.

Exclusion Criteria

You have high blood sugar, as indicated by a test called HbA1c or fasting blood sugar.

I or someone in my family has had bladder cancer.

I have had surgery on my upper stomach area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive pioglitazone (30 mg po qd) for 8 weeks to evaluate improvement in gastroparesis symptoms

8 weeks

Washout

Participants undergo a washout period to assess the effects of discontinuing pioglitazone

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pioglitazone

Trial Overview The study is testing if Pioglitazone (30 mg) taken for 8 weeks improves gastroparesis symptoms based on the Gastrointestinal Symptom Index scores. It's designed to see if this treatment helps reduce problems like nausea and abdominal pain in patients without clear causes for their condition.

How Is the Trial Designed?

Group I: Pioglitazone Experimental Treatment 1 Intervention

Candidates who after the screening period are eligible to receive Pioglitazone

Pioglitazone is already approved in United States for the following indications:

Approved in United States as Actos for:

• Type 2 diabetes mellitus

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04300127

NCT04300127 | Pioglitazone for Idiopathic Gastroparesis The principal objective of this pilot study will be to evaluate whether 8 weeks of treatment of pioglitazone will improve symptoms as measured by the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6165730/

Diabetic gastroparesis: current challenges and future prospects Domperidone in the management of symptoms of diabetic gastroparesis: efficacy, tolerability, and quality-of-life outcomes in a multicenter controlled trial.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/27/NCT04300127/Prot_SAP_000.pdf

Pioglitazone for Idiopathic Gastroparesis NCT04300127 8/ ... Objective. • The principal objective of this pilot study will be to evaluate whether 8 weeks of treatment of pioglitazone will improve ...

4. withpower.com withpower.com/trial/early-phase-1-gastroparesis-9-2019-b8be7

Pioglitazone for Gastroparesis (PIOGAS Trial) Trial Overview The study is testing if Pioglitazone (30 mg) taken for 8 weeks improves gastroparesis symptoms based on the Gastrointestinal Symptom Index scores ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3411525/

Pioglitazone in the Treatment of Type 2 Diabetes Most recent data from Defronzo et al has shown that use of pioglitazone 45 mg reduced the incidence of type 2 diabetes by around 62%. Separately rosiglitzone ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6235707/

Phase 1 safety and pharmacokinetic study on the use of ... We demonstrate that pioglitazone is safe when administered to critically ill pediatric patients. Furthermore, pioglitazone exposure was associated with a ...

7. cureus.com cureus.com/articles/189310-association-of-pioglitazone-with-major-adverse-cardiovascular-events-all-cause-mortality-and-heart-failure-hospitalizations-a-systematic-review

Association of Pioglitazone With Major Adverse ... In patients with T2DM with a high risk of macrovascular events, pioglitazone lowers the risk of all-cause mortality, non-fatal myocardial ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S014929182400198X

Efficacy and Safety of Pioglitazone Add-on in Patients with ... The purpose of this study was to determine the efficacy and safety profile of pioglitazone compared with placebo (PBO) in patients with type 2 diabetes (T2D)