Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis

Overseen By Shailendra Singh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Must not be taking: Anticoagulants, Amiodarone, Tamoxifen, Estrogens

Disqualifiers: Type 1 diabetes, Prior bariatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Endoscopic weight loss procedures, also termed endoscopic sleeve gastroplasty (ESG), has been proposed as a non-surgical procedure for managing obesity and offers a standard weight loss approach. Realizing there is a knowledge gap in applying ESG to morbidly obese patients with NAFLD, the investigators propose studying the efficacy of weight control and functional outcomes of ESG. This prospective pilot study is aimed to study the safety profiles, quality of life, and changes and improvements in the anthropometric, metabolic, and biochemical changes in these patients.

Research Team

Shailendra Singh, MD

Principal Investigator

West Virginia University

Eligibility Criteria

Inclusion Criteria

Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG

Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)

Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic sleeve gastroplasty (ESG) for weight loss management

6 months

Regular follow-up visits as per study protocol

Follow-up

Participants are monitored for safety, quality of life, and changes in anthropometric, metabolic, and biochemical parameters

12 months

Treatment Details

Interventions

• Endoscopic Sleeve Gastroplasty

Participant Groups

Group I: Endoscopic Sleeve Gastroplasty Experimental Treatment 1 Intervention

endoscopic suturing of the stomach

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+