What side effects are associated with this type of intervention?

Common treatments for obesity include dietary interventions, medications like orlistat, lorcaserin, and phentermine/topiramate, and devices such as gastric balloons and gastrointestinal liners like the RESET System. Known side effects of these treatments can vary. Orlistat may cause gastrointestinal issues like oily stools and flatulence. Lorcaserin has been associated with headaches, dizziness, and fatigue. Phentermine/topiramate can lead to increased heart rate, insomnia, and dry mouth. Gastric balloons may cause nausea, vomiting, and abdominal pain. The RESET System, specifically, can lead to gastrointestinal symptoms such as nausea, vomiting, and potential device-related complications like gastrointestinal bleeding or obstruction.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity that aim to promote weight loss and improve glycemic control. These include orlistat, which reduces fat absorption in the intestines, and glucagon-like peptide-1 (GLP-1) receptor agonists like liraglutide, which enhance satiety and delay gastric emptying. Additionally, combination drugs such as phentermine/topiramate have been approved for their synergistic effects on appetite suppression and increased energy expenditure. While these treatments do not create a physical barrier like the RESET System, they share the goal of reducing caloric intake and improving metabolic outcomes.

What other types of research exist?

Promising alternatives to the RESET System for obesity treatment in 2024 include: 1) GLP-1 receptor agonists, which enhance GLP-1 secretion and improve glycemic control; 2) Intragastric balloons, although their efficacy is debated, they remain a non-invasive option; 3) Bariatric surgery options like laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass, which have shown significant weight loss and glycemic improvement; 4) Endoscopic sleeve gastroplasty, a less invasive procedure that reduces stomach size and has shown promising results in weight loss.

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Procedure

RESET Liner for Type-2 Diabetes and Obesity (STEP-1 Trial)

Verified Trial

N/A

Recruiting

Led By Christopher C Thompson, MD

Research Sponsored by Morphic Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you been diagnosed with Type 2 diabetes?

Are you currently taking at least two medications to manage your diabetes?

Timeline

Screening 1 week

Treatment 21 days

Follow Up 4 weeks

Summary

This trial is testing the RESET System, a device placed in the stomach, to help people with Type 2 Diabetes and Obesity who haven't controlled their blood sugar well with current medications. The device works by reducing food absorption, aiding in better blood sugar control and weight loss. The RESET System has been shown to help with weight loss and better blood sugar control in patients with type 2 diabetes.

Who is the study for?

This trial is for adults aged 22-65 with type 2 diabetes, HbA1c levels between 7.5% and 10%, BMI between 30 and 50, but have been on other diabetes meds without adequate control including insulin. Women must use birth control to prevent pregnancy during the trial.

What is being tested?

The RESET System's effectiveness in improving blood sugar levels in patients with poorly controlled type 2 diabetes and obesity is being tested against a sham (fake) procedure, alongside lifestyle and dietary counseling based on ADA standards.

What are the potential side effects?

While specific side effects are not listed here, interventions like RESET may cause gastrointestinal discomfort or complications, nutritional deficiencies due to malabsorption, or potential issues at the implant site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 1 week1 visit

Treatment ~ 21 days18 visits

Follow Up ~ 4 weeks18 visits

Screening ~ 1 week

Treatment ~ 21 days

Follow Up ~4 weeks

This trial's timeline: 1 week for screening, 21 days for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HbA1c

Secondary study objectives

Blood pressure

Change in Nonalcoholic Fatty Liver Disease (NAFLD)

Change in Nonalcoholic Steatohepatitis (NASH)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RESETExperimental Treatment1 Intervention

Patients in ARM 1, will receive an upper endoscopy and will be treated with RESET

Group II: ShamPlacebo Group1 Intervention

Patients in Arm 2 will receive an upper endoscopy, but will not be treated with RESET.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RESET

2021

N/A

~100

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as the RESET System, work by creating a physical barrier between food and the intestinal wall, which delays nutrient absorption and promotes weight loss and glycemic control. This mechanism is crucial for obesity patients as it helps reduce caloric intake and improves metabolic parameters, leading to better weight management and reduced risk of obesity-related complications. Other treatments, like GLP-1 receptor agonists, enhance satiety and slow gastric emptying, further aiding in weight loss and glycemic control. These approaches are significant as they address both the physical and hormonal aspects of obesity, providing a comprehensive strategy for managing the condition.

Can medical therapy mimic the clinical efficacy or physiological effects of bariatric surgery?Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes.