Gastric Fundal Mucosal Ablation for Obesity

(MAINTAIN Trial)

Overseen by Christopher McGowan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dr. Christopher McGowan

Must not be taking: Anticoagulants, NSAIDs, Weight loss drugs

Disqualifiers: Diabetes, Stomach manipulation, Active disordered eating, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the effect of gastric fundal mucosal ablation (GFMA) on weight trajectory following discontinuation of once-weekly semaglutide or tirzepatide in adults with obesity. In this study, GFMA will be performed on patients who have experienced \> 10% weight loss with GLP-1 therapy and who plan to discontinue use of GLP-1 medications for the duration of the study.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. Participants must discontinue semaglutide or tirzepatide and cannot use medications that affect blood clotting, certain hormones, or those known to induce weight loss during the study.

What data supports the effectiveness of the treatment Gastric Fundal Mucosal Ablation (GFMA) for obesity?

The research does not provide direct evidence for the effectiveness of Gastric Fundal Mucosal Ablation (GFMA) for obesity, but it does mention that bariatric surgery is the most effective long-term treatment for obesity, suggesting that surgical interventions can be beneficial for weight loss. ^{1 2 3 4 5}

How is Gastric Fundal Mucosal Ablation (GFMA) different from other obesity treatments?

Gastric Fundal Mucosal Ablation (GFMA) is unique because it targets the stomach lining (mucosa) for weight loss, unlike other procedures that alter the stomach's size or shape, such as gastric fundus invagination or gastric plication, which physically change the stomach's structure to limit food intake. ^{1 6 7 8 9}

Research Team

Christopher McGowan, MD

Principal Investigator

True You Weight Loss

Eligibility Criteria

The MAINTAIN trial is for adults with obesity who have lost more than 10% of their weight using GLP-1 therapy like semaglutide or tirzepatide and are planning to stop taking these medications. The study aims to see if a procedure called GFMA can help maintain their weight loss after stopping the medication.

Inclusion Criteria

Willing and able to participate in the study procedures

Access to internet

Reliable transportation

Exclusion Criteria

Active disordered eating

Unwillingness to abstain from the use of tobacco during the study duration

Patients who are pregnant, who plan to become pregnant during study duration, or patients of child-bearing potential who refuse effective birth control methods (as approved by PI)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events, appetite, BMI, weight recurrence, and quality of life

12 months

Monthly assessments

Treatment Details

Interventions

• Gastric Fundal Mucosal Ablation (GFMA) (Procedure)

Trial Overview This clinical trial tests Gastric Fundal Mucosal Ablation (GFMA), a procedure designed to help individuals maintain their weight loss achieved through GLP-1 therapy, even after they've stopped taking the GLP-1 drugs.

Participant Groups

Group I: Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy Experimental Treatment 1 Intervention

Subjects will undergo endoscopic Gastric Fundal Mucosal Ablation (GFMA) following following discontinuation of GLP-1 therapy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session.

Who Is Running the Clinical Trial?

Dr. Christopher McGowan

Lead Sponsor

Trials

2

Recruited

30+

Findings from Research

Gastric fundus invagination (GFI) surgery resulted in lower fasting ghrelin levels compared to gastric plication (GP), suggesting a more effective mechanism for weight loss through hormonal regulation.

GFI demonstrated better durability, as all GFI rats maintained their fundus invagination, while three GP rats experienced unfurling of the plication, indicating that GFI may be a more reliable surgical option for long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of gastric fundus invagination and gastric greater curvature plication for weight loss in a rat model of diet-induced obesity. Darido, E., Moore, JR.[2021]

Gastric bypass surgery, although technically challenging and associated with a higher risk of complications, is an effective treatment for controlling gastroesophageal reflux in obese patients who have previously undergone antireflux surgery, with most patients experiencing complete symptom remission.

In a review of 121 patients, the average body mass index was 37.17 kg/m², and the surgery resulted in significant excess weight loss alongside improved reflux symptoms, highlighting its dual benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FUNDOPLICATION CONVERSION IN ROUX-EN-Y GASTRIC BYPASS FOR CONTROL OF OBESITY AND GASTROESOPHAGEAL REFLUX: SYSTEMATIC REVIEW. Mendes-Filho, AM., Godoy, ESN., Alhinho, HCAW., et al.[2022]

In a study of 13 post-OAGB patients, the excluded stomach fundoplication (ESF) procedure significantly improved symptoms of gastroesophageal reflux, with heartburn scores dropping from an average of 22.7 to 1.8 (p < 0.05).

After ESF, 100% of patients reported satisfaction with their symptom improvement, and 11 out of 12 patients no longer needed proton pump inhibitors (PPIs), indicating the procedure's efficacy in managing refractory bile reflux.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Fundoplication Using the Excluded Stomach as a Novel Management Option for Refractory Bile Reflux Following One Anastomosis Gastric Bypass (OAGB). Werapitiya, SB., Ruwanpura, SP., Coulson, TR.[2022]

Combining Silastic ring vertical gastroplasty with Nissen fundoplication in an animal model effectively protects against gastroesophageal reflux.

The combined procedures did not negatively impact pouch emptying, suggesting a safe approach for managing both morbid obesity and gastroesophageal reflux.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vertical Silastic Ring Gastroplasty with Nissen Fundoplication Prevents Reflux. Fisher, BL., Little, AG.[2019]

Bariatric surgery is the most effective long-term treatment for obesity, significantly improving weight loss and reducing obesity-related health complications, especially in patients with a BMI over 40 or over 35 with related health issues.

While bariatric surgery can lead to decreased overall mortality, careful patient selection is crucial due to the potential for serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of obesity. Bult, MJ., van Dalen, T., Muller, AF.[2022]

In a study of 35 patients undergoing surgical revision for gastrogastric fistula (GGF) after obesity surgery, those who had prior endoscopic closure attempts did not experience higher surgical complications compared to those who went directly to surgery.

The overall complication rates were 40.9% for the endoscopy group and 46.1% for the surgery-only group, indicating that prior endoscopic intervention is safe and does not negatively impact surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic management of gastrogastric fistulae does not increase complications at bariatric revision surgery. Flicker, MS., Lautz, DB., Thompson, CC.[2021]

Endoscopic repair of gastrogastric fistulas (GGFs) after Roux-en-Y gastric bypass is technically feasible and achieved a high initial closure rate of 95% in a study of 95 patients.

However, the durability of the closure is limited, with 65% of the fistulas reopening within an average of 177 days, and larger fistulas (over 20 mm) had a significantly lower chance of remaining closed compared to smaller ones (10 mm or less).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic repair of gastrogastric fistula after Roux-en-Y gastric bypass: a less-invasive approach. Fernandez-Esparrach, G., Lautz, DB., Thompson, CC.[2010]

Obesity is a significant risk factor for various gastrointestinal and hepatic diseases, including nonalcoholic fatty liver disease, gastroesophageal reflux disease, and several types of cancer, highlighting the need for awareness of these complications among healthcare providers.

Gastroenterologists play a crucial role in managing obesity-related diseases due to their expertise in nutrition and endoscopic interventions, making them key players in a multidisciplinary approach to treating obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal Complications of Obesity. Camilleri, M., Malhi, H., Acosta, A.[2022]

A study analyzing gastric mucosa samples from control subjects and patients with obesity and diabetes revealed significant changes in gene expression, with 1756 genes upregulated and 1053 downregulated in patients with obesity and diabetes compared to controls.

Key pathways affected include the PI3K-Akt and AGE-RAGE signaling pathways, which are crucial for metabolic processes, indicating that the stomach plays a significant role in the mechanisms underlying obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key pathway and gene alterations in the gastric mucosa associated with obesity and obesity-related diabetes. Wen, X., Qian, C., Zhang, Y., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of gastric fundus invagination and gastric greater curvature plication for weight loss in a rat model of diet-induced obesity. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

FUNDOPLICATION CONVERSION IN ROUX-EN-Y GASTRIC BYPASS FOR CONTROL OF OBESITY AND GASTROESOPHAGEAL REFLUX: SYSTEMATIC REVIEW. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Fundoplication Using the Excluded Stomach as a Novel Management Option for Refractory Bile Reflux Following One Anastomosis Gastric Bypass (OAGB). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Vertical Silastic Ring Gastroplasty with Nissen Fundoplication Prevents Reflux. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Surgical treatment of obesity. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Endoscopic management of gastrogastric fistulae does not increase complications at bariatric revision surgery. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Endoscopic repair of gastrogastric fistula after Roux-en-Y gastric bypass: a less-invasive approach. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

Gastrointestinal Complications of Obesity. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Key pathway and gene alterations in the gastric mucosa associated with obesity and obesity-related diabetes. [2020]