pioglitazone for idiopathic gastroparesis

Conditions: Gastroparesis

Summary: 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.

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.

Eligibility criteria:
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