15 Participants NeededMy employer runs this trial

Metformin for Jelly Belly

CF
Uo
Overseen ByUniversity of California Irvine Medical
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests metformin, a common diabetes medication, to determine its effectiveness in treating pseudomyxoma peritonei (PMP), a rare condition often linked to tumors in the appendix. Researchers aim to discover if metformin can serve as a viable treatment for individuals with PMP who have tried other treatments like surgery and chemotherapy or have tumors that cannot be removed. This trial suits adults diagnosed with PMP related to appendiceal tumors who are not currently taking metformin for another condition. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that metformin is likely to be safe for humans?

Research has shown that metformin is generally safe for use. It is often prescribed for diabetes and is known for its safety profile. Some individuals may experience stomach issues when starting metformin, but these symptoms typically improve over time.

There is a rare but serious risk of lactic acidosis with metformin, where lactic acid accumulates in the blood and can be dangerous. Monitoring for symptoms like unusual tiredness or muscle pain is important.

Long-term use of metformin can lead to a vitamin B12 deficiency, potentially causing fatigue or faintness. Despite these risks, metformin remains widely used and is considered safe for many individuals.12345

Why do researchers think this study treatment might be promising for PMP?

Most treatments for "jelly belly," or excess abdominal fat, focus on diet and exercise, often with added weight-loss medications like orlistat or phentermine. But metformin, a medication typically used for diabetes, is showing promise for this condition. Researchers are excited about metformin because it targets insulin sensitivity and glucose metabolism, which is a unique approach compared to traditional weight-loss drugs. Additionally, metformin is taken orally and has a long history of safety and tolerability in diabetic patients, making it a potentially attractive option for those looking to manage abdominal fat without significant side effects.

What evidence suggests that metformin might be an effective treatment for pseudomyxoma peritonei?

Research has shown that metformin is commonly used to manage diabetes by lowering blood sugar levels. One study found that it reduces the risk of developing diabetes by 31% compared to a placebo. Metformin also aids in weight control, with some individuals losing and maintaining a small amount of weight over time. Although primarily used for diabetes, metformin's effects on blood sugar and weight might benefit other conditions like pseudomyxoma peritonei (PMP), a rare cancer. In this trial, participants will receive metformin to explore its potential for treating PMP. While researchers continue to study its potential for this condition, its impact on metabolism appears promising.678910

Who Is on the Research Team?

OE

Oliver Eng, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with pseudomyxoma peritonei (a rare abdominal cancer) that started from an appendiceal mucinous tumor. Participants should be able to safely take metformin and meet other health requirements set by the study.

Inclusion Criteria

I am able to care for myself and do light activities.
I have PMP from AMNs that has come back, can't be removed, or I haven't had CRS/HIPEC planned.
I am 18 years old or older.

Exclusion Criteria

I have PMP from AMNs and my disease can be removed with surgery.
I have had a bad reaction to metformin before.
I am currently taking metformin for another health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metformin therapy for pseudomyxoma peritonei secondary to appendiceal mucinous neoplasms

18 months
Regular visits for monitoring and assessment at 6, 12, and 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Metformin

Trial Overview

The study is testing whether metformin, a common diabetes medication, can be used safely and effectively in people with this type of rare abdominal cancer. All participants will receive metformin; there is no placebo group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Metformin TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Citations

The Effectiveness of Metformin in Diabetes Prevention - PMC

Over a two-year and eight-month average follow-up period, metformin lowered the chance of getting diabetes by 31% compared to a placebo group.

NCT05949008 | Effect of Metformin, a Drug Used to Treat ...

The aim of this study is to examine the effect of Metformin along with a low-calorie diet on obese and/or overweight adults with an increased waist measurement.

Comparative effectiveness trial of metformin versus insulin for ...

Both insulin and metformin reduce the risk of adverse pregnancy outcomes, metformin does not cause hypoglycaemia and reduces gestational weight ...

Metformin vs Lifestyle: 20-Year Diabetes Study Results

The intensive lifestyle intervention reduced the development of diabetes by 24%, and metformin reduced diabetes development by 17%, according to ...

Wegovy vs. metformin: Differences, similarities & side effects

metformin lost an average of 4.6 pounds (2.1 kg) within three years. Over time, they maintained an average weight loss of 5.5 pounds (2.5 kg). ...

Is metformin safe?

Metformin can cause a rare but serious and life-threatening condition called lactic acidosis—a condition in which there is too much lactic acid in the blood.

Metformin for Diabetes: Dosage, Side Effects, Weight Loss

Metformin has a boxed warning for lactic acidosis, a dangerous build-up of lactic acid in your blood, which can cause death, hypothermia, hypotension, and ...

Long-Term Safety, Tolerability, and Weight Loss Associated ...

No significant safety issues were identified. Gastrointestinal symptoms were more common in metformin than placebo participants and declined over time. ...

Metformin-WGR

Do not take this medicine if you are pregnant or plan to become pregnant. The safety of METFORMIN-WGR in pregnant women has not been established. Insulin is ...

FDA Updates and Press Announcements on NDMA in ...

The company is recalling the lot because the metformin may contain N-nitrosodimethylamine (NDMA) above the acceptable intake limit. FDA publishes a recalled ...