Proton Pump Inhibitors for Obesity
(LiverLabPPI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how weight might influence the way children process acid suppression medications, focusing specifically on pantoprazole, a proton pump inhibitor. Researchers aim to determine if liver fat or participation in a weight management program affects the medication's efficacy. The trial is open to children and young adults, ages 6 to 21, who are either obese or not, and who are generally healthy or have conditions like GERD (chronic acid reflux) or NAFLD (liver fat). Participants must be able to undergo MRI scans and be willing to stop certain medications before the trial. As a Phase 4 trial, this study involves an FDA-approved medication and seeks to understand its benefits for a broader patient population.
Do I have to stop taking my current medications for the trial?
You may need to stop taking certain medications before joining the trial. If you are taking specific proton pump inhibitors like omeprazole or esomeprazole, or other medications that affect liver enzymes, you should not have taken them in the last 7 days. If you are taking lansoprazole or pantoprazole, you must stop 3 days before certain study visits.
What is the safety track record for Pantoprazole?
Research has shown that proton pump inhibitors (PPIs), such as pantoprazole, are generally safe. A large study involving 17,598 patients found that PPIs rarely cause significant harm, with serious side effects being uncommon.
Another study examined children with obesity and discovered that pantoprazole remains in their bodies longer and at higher levels. However, no clear evidence indicates that this results in more side effects.
The FDA has already approved pantoprazole for treating acid-related issues in both adults and children. This approval suggests that the drug is generally well-tolerated, even as this study explores its effects in a new context.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for obesity, which often involve lifestyle changes and medications like appetite suppressants or fat absorption inhibitors, pantoprazole is being explored for its potential effects on obesity through its impact on liver fat and drug metabolism. Researchers are excited because pantoprazole, a proton pump inhibitor typically used for acid-related stomach issues, might offer a novel approach by targeting the pharmacological and metabolic pathways influenced by liver fat. This could provide a new angle in managing obesity, especially for individuals whose liver fat significantly affects how drugs are processed in their bodies.
What is the effectiveness track record for Pantoprazole in treating obesity?
Research shows that pantoprazole, a proton pump inhibitor (PPI), usually treats acid-related problems effectively. However, studies have found that pantoprazole may behave differently in children with obesity. These children might have higher drug levels in their bodies and take longer to clear it compared to children without obesity. While pantoprazole remains effective for acid-related issues, its impact can change due to these differences. This trial will compare children in a weight management program with those not in the program to learn more about how obesity might affect pantoprazole's effectiveness and processing in the body.14567
Who Is on the Research Team?
Kathryn Kyler, MD, MS
Principal Investigator
Children's Mercy Hospital Kansas City
Are You a Good Fit for This Trial?
This trial is for children and young adults aged 6-21 with a BMI in the healthy range or higher, who may be generally healthy or have conditions like GERD, NAFLD, chronic abdominal pain, or obesity. Participants can currently be taking pantoprazole or lansoprazole. Those over 500lbs, with significant liver/renal impairment, pregnant/breastfeeding females, individuals with certain infections (hepatitis B/C/HIV), and those unable to undergo MRI due to metal implants are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are evaluated for the effect of liver fat on the pharmacology of PPIs and midazolam, if applicable
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pantoprazole
Pantoprazole is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
- Erosive esophagitis
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Erosive esophagitis
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Peptic ulcer disease
- Erosive esophagitis
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Erosive esophagitis
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Erosive esophagitis
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Erosive esophagitis
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas City
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator