Pioglitazone for Idiopathic Gastroparesis (PIOGAS)

Johns Hopkins University

Status and phase

Completed

Early Phase 1

Conditions

Gastroparesis

Treatments

Drug: Pioglitazone 30 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04300127

IRB00184232

Details and patient eligibility

About

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 Gastrointestinal Symptom Index (GCSI) in patients with Idiopathic Gastroparesis.

Full description

Objective • 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 Gastrointestinal Symptom Index Daily Diary (GCSI-DD) in patients with Idiopathic Gastroparesis

Secondary objectives of this study include:

To determine the effects of pioglitazone on other symptoms associated with gastroparesis using the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) and the Gastrointestinal Symptom Rating Scale (GSRS),
To determine the effects of pioglitazone on gastric emptying as measured by the 13C- Spirulina breath test,
To determine the effects of pioglitazone on satiety as measured by a liquid caloric test
To determine the effects of pioglitazone on depression and anxiety using the Beck Depression Inventory and State-Trait Anxiety Scores,
To determine the effects of pioglitazone on Quality of Life using the PAGI-QoL and Short Form (SF)-36 questionnaire,
To determine the effects of pioglitazone on markers of inflammation (CRP and ESR) and serum cytokine levels
To determine the nature and incidence of adverse effects from a 12-week course of pioglitazone.

Treatment group

• Pioglitazone (30 mg po qd)

Population • Age 18 years or older at registration with nausea, vomiting, and other symptoms suggestive of patients with chronic nausea and vomiting of presumed gastric origin, with symptomatic gastroparesis.

Study duration

Up to 4 weeks of screening prior to pioglitazone treatment
8 weeks of treatment starting at initial dose of pioglitazone
4 weeks of washout period
Length of recruitment: 16 months

Sample size justification

Total of 23 patients
Primary comparison: Baseline PAGI-SYM score versus 4, 8, and 12 weeks.

Number of clinical centers

• Johns Hopkins Bayview Medical Center.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or older at registration
Diagnosis of gastroparesis as documented by gastric emptying scintigraphy (4-hour emptying after a low-fat meal with any combination of 2 and 4 hour retention of >60% and 10% respectively)
Ongoing symptoms referable to gastroparesis (i.e. Nausea and vomiting, bloating, and abdominal pain)
Exclusion of other causes of symptoms such as mechanical gastrointestinal obstruction, uncontrolled esophagitis, peptic ulcer disease, etc. By standard radiographic or endoscopic tests
Females will be required to use adequate contraceptive methods during study participation as determined by the Principal Investigator and the study team members

Exclusion criteria

Another active disorder, which could explain symptoms in the opinion of the investigator
Age < than 18 years
Pregnancy or nursing
Previous surgery of the upper gastrointestinal tract, including vagotomy
Another active disorder, which could explain symptoms in the opinion of the investigator
Use of narcotics more than 3 days per week
Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2 x upper limit of normal (ULN) or a Child-Pugh score of 10 or greater
Serious systemic disease, such as recent myocardial infarction/unstable angina, decompensated congestive heart failure, severe pulmonary disease with dyspnea at rest, or altered mental status from any cause
Diabetes as defined by HbA1c >6.5 and/or fasting blood sugar of >125 mg/DL
Contraindications to pioglitazone such as hypersensitivity or allergy
Concurrent use of: estradiol, ethynyl estradiol, mestranol, pazopanib, warfarin, digoxin, atorvastatin, ranitidine, gemfibrozil, fexofenadine, midazolam
Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
History of bladder cancer or family history of bladder cancer
Failure to give informed consent