Back to resultsPioglitazone for Idiopathic Gastroparesis (PIOGAS)
Primary Purpose
Gastroparesis
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pioglitazone 30 mg
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis
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
Sites / Locations
- Johns Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pioglitazone
Arm Description
Candidates who after the screening period are eligible to receive Pioglitazone
Outcomes
Primary Outcome Measures
Change in Severity of gastrointestinal symptoms as assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary
The effect of Pioglitazone on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) which has been designed to assess symptoms associated with gastroparesis. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours.
Secondary Outcome Measures
Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale
The effect of Pioglitazone on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QOL instrument consists of 30 items, each with response options based on a 6-point scale and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. A score per dimension as well as a total score can be calculated. The PAGI-QOL scores range from 0 (lowest QoL) to 5 (highest QoL).
Change in Functional status as assessed by the SF-36v2 Health Survey
The effect of Pioglitazone on quality of life assessed by the SF-36v2 Health Survey. The SF-36v2 is a 36-item, self-report measure designed to assess quality of life in patients. This measure also provides two summary scores (physical and mental health) and eight scale scores. The eight sections are: vitality, physical functioning, bodily pain and general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change in C- reactive protein level in blood
The effect of Pioglitazone on Inflammatory markers as per changes in the values of C reactive protein (CRP) in blood. Normal CRP levels are below 3.0 mg/L.
Change in Erythrocyte Sedimentation Rate
The effect of Pioglitazone on Inflammatory markers as per changes Erythrocyte Sedimentation Rate (ESR) in blood. Results are reported as the millimeters of clear fluid (plasma) that are present at the top portion of the tube after one hour. The normal range is 0 to 22 mm/hr for men and 0 to 29 mm/hr for women.
Change in Mood as assessed by the Beck Depression Inventory
The effect of Pioglitazone on mood as per changes in the score of Beck Depression Inventory (BDI-II). The BDI-II is a commonly used, reliable 21-item self-report measure designed to assess for depression. Individuals are asked to respond to each question based on a two-week time period. The BDI-II is widely used as an indicator of the severity of depression, but not as a diagnostic tool. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on the severity of each item. The maximum total score is 63.
Change in Mood as assessed by the State-Trait Anxiety Inventory
The effect of Pioglitazone on mood as per changes in the score of the State-Trait Anxiety Inventory (STAI). The STAI is a 40-item self-report measure designed to assess anxiety. This measure provides two subscale scores (State and Trait). STAI is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Change in Behavior as assessed by the Beck Depression Inventory
The effect of Pioglitazone on behavior as per changes in the score of Beck Depression Inventory (BDI-II). The BDI-II is a commonly used, reliable 21-item self-report measure designed to assess for depression. Individuals are asked to respond to each question based on a two-week time period. The BDI-II is widely used as an indicator of the severity of depression, but not as a diagnostic tool. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on the severity of each item. The maximum total score is 63.
Change in Behavior as assessed by the State-Trait Anxiety Inventory
The effect of Pioglitazone on behavior as per changes in the score of the State-Trait Anxiety Inventory (STAI). The STAI is a 40-item self-report measure designed to assess anxiety. This measure provides two subscale scores (State and Trait). STAI is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04300127
Brief Title
Pioglitazone for Idiopathic Gastroparesis
Acronym
PIOGAS
Official Title
Pioglitazone for the Treatment of Idiopathic Gastroparesis (PIOGAS Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
September 29, 2024 (Anticipated)
Study Completion Date
October 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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 10 patients
Primary comparison: Baseline PAGI-SYM score versus 4, 8, and 12 weeks.
Number of clinical centers
• Johns Hopkins Bayview Medical Center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pioglitazone
Arm Type
Experimental
Arm Description
Candidates who after the screening period are eligible to receive Pioglitazone
Intervention Type
Drug
Intervention Name(s)
Pioglitazone 30 mg
Intervention Description
Patients will received 30 mg of Pioglitazone once a day for 8 weeks
Primary Outcome Measure Information:
Title
Change in Severity of gastrointestinal symptoms as assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary
Description
The effect of Pioglitazone on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) which has been designed to assess symptoms associated with gastroparesis. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours.
Time Frame
Daily up to 3 months
Secondary Outcome Measure Information:
Title
Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale
Description
The effect of Pioglitazone on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QOL instrument consists of 30 items, each with response options based on a 6-point scale and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. A score per dimension as well as a total score can be calculated. The PAGI-QOL scores range from 0 (lowest QoL) to 5 (highest QoL).
Time Frame
1 day before treatment and 12 weeks after treatment
Title
Change in Functional status as assessed by the SF-36v2 Health Survey
Description
The effect of Pioglitazone on quality of life assessed by the SF-36v2 Health Survey. The SF-36v2 is a 36-item, self-report measure designed to assess quality of life in patients. This measure also provides two summary scores (physical and mental health) and eight scale scores. The eight sections are: vitality, physical functioning, bodily pain and general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
1 day before treatment and 12 weeks after treatment
Title
Change in C- reactive protein level in blood
Description
The effect of Pioglitazone on Inflammatory markers as per changes in the values of C reactive protein (CRP) in blood. Normal CRP levels are below 3.0 mg/L.
Time Frame
1 day before treatment and after 8 weeks of treatment
Title
Change in Erythrocyte Sedimentation Rate
Description
The effect of Pioglitazone on Inflammatory markers as per changes Erythrocyte Sedimentation Rate (ESR) in blood. Results are reported as the millimeters of clear fluid (plasma) that are present at the top portion of the tube after one hour. The normal range is 0 to 22 mm/hr for men and 0 to 29 mm/hr for women.
Time Frame
1 day before treatment and after 8 weeks of treatment
Title
Change in Mood as assessed by the Beck Depression Inventory
Description
The effect of Pioglitazone on mood as per changes in the score of Beck Depression Inventory (BDI-II). The BDI-II is a commonly used, reliable 21-item self-report measure designed to assess for depression. Individuals are asked to respond to each question based on a two-week time period. The BDI-II is widely used as an indicator of the severity of depression, but not as a diagnostic tool. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on the severity of each item. The maximum total score is 63.
Time Frame
1 day before treatment and 12 weeks after treatment
Title
Change in Mood as assessed by the State-Trait Anxiety Inventory
Description
The effect of Pioglitazone on mood as per changes in the score of the State-Trait Anxiety Inventory (STAI). The STAI is a 40-item self-report measure designed to assess anxiety. This measure provides two subscale scores (State and Trait). STAI is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Time Frame
1 day before treatment and 12 weeks after treatment
Title
Change in Behavior as assessed by the Beck Depression Inventory
Description
The effect of Pioglitazone on behavior as per changes in the score of Beck Depression Inventory (BDI-II). The BDI-II is a commonly used, reliable 21-item self-report measure designed to assess for depression. Individuals are asked to respond to each question based on a two-week time period. The BDI-II is widely used as an indicator of the severity of depression, but not as a diagnostic tool. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on the severity of each item. The maximum total score is 63.
Time Frame
1 day before treatment and 12 weeks after treatment
Title
Change in Behavior as assessed by the State-Trait Anxiety Inventory
Description
The effect of Pioglitazone on behavior as per changes in the score of the State-Trait Anxiety Inventory (STAI). The STAI is a 40-item self-report measure designed to assess anxiety. This measure provides two subscale scores (State and Trait). STAI is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Time Frame
1 day before treatment and 12 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn J Treisman, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pioglitazone for Idiopathic Gastroparesis
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