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 10 patients~Primary comparison: Baseline PAGI-SYM score versus 4, 8, and 12 weeks.~Number of clinical centers~• Johns Hopkins Bayview Medical Center.
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.