What is the mechanism of action of this treatment?

The most common treatments for Type 2 Diabetes include incretin-based therapies such as GLP-1 receptor agonists and DPP-4 inhibitors, as well as dietary interventions like meal replacement systems. GLP-1 receptor agonists enhance insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety, leading to weight loss and improved glycemic control. DPP-4 inhibitors increase the levels of incretin hormones, which also help regulate blood sugar levels. Meal replacement systems focus on significant weight loss, which is strongly associated with diabetes remission. These treatments are crucial for T2D patients as they address both hyperglycemia and obesity, two key factors in the progression and management of the disease.

What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes that focus on weight loss include lifestyle interventions, GLP-1 receptor agonists, and alpha-glucosidase inhibitors. Lifestyle interventions, such as intensive caloric restriction and meal replacements, can lead to gastrointestinal discomfort and nutritional deficiencies if not properly managed. GLP-1 receptor agonists like liraglutide and semaglutide often cause gastrointestinal side effects, including nausea and vomiting, and may require injections. Alpha-glucosidase inhibitors, such as acarbose, can cause gastrointestinal issues like flatulence, diarrhea, and abdominal pain. These treatments aim to improve glycemic control and promote weight loss but must be monitored for these potential side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes that also promote weight loss, similar to the approach in the Meal Replacement Dietary System trial. Notable among these are GLP-1 receptor agonists such as liraglutide and extended-release exenatide, which have shown significant improvements in glycemic control and modest weight loss in pediatric and adult populations. Liraglutide, for instance, demonstrated a reduction in HbA1c and weight loss in the ELLIPSE trial, leading to its approval for children aged 10 and above. Similarly, extended-release exenatide was approved based on its efficacy in improving glycemic control and modest weight reduction. These treatments align with the weight-centric approach to managing T2DM, emphasizing the dual benefits of glycemic control and weight loss.

What other types of research exist?

Promising novel alternatives for weight loss in Type 2 Diabetes patients include: 1) Pramlintide, an amylin analog, which has shown sustained reductions in A1C and body weight. 2) GLP-1 receptor agonists like liraglutide and exenatide, which improve glycemic control and induce significant weight loss. 3) Incretin-based therapies that stabilize glycemic control and suppress appetite. These alternatives offer effective glycemic management and weight reduction, making them viable options for Type 2 Diabetes treatment in 2024.

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Meal Replacement System

Meal Replacement System for Type 2 Diabetes (DRS Trial)

N/A

Waitlist Available

Led By Warren Peters, MD

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and six month visit.

Awards & highlights

Summary

This trial uses a meal replacement diet combined with self-prepared meals to help people with Type 2 Diabetes who don't use insulin. The goal is to help them lose 20-30 pounds, which can improve their blood sugar levels and possibly lead to diabetes remission without medication. Meal replacement plans have been shown to be effective in weight loss and improving glycemic control in patients with type-2 diabetes.

Who is the study for?

This trial is for English-speaking men and women aged 25-65 who have been diagnosed with non-insulin dependent Type 2 Diabetes within the last five years. Participants should be taking oral diabetes medication but not have had recent significant weight loss, bariatric surgery, or use of anti-obesity drugs.

What is being tested?

The study tests a meal replacement system combined with an intensive lifestyle program over three months to see if it can lead to significant weight loss and help patients achieve diabetes remission without medication.

What are the potential side effects?

Potential side effects may include nutritional deficiencies due to diet changes, gastrointestinal discomfort from new foods in the meal plan, and possible increased hunger or fatigue during the initial adjustment period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and six month visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline and six month visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and six month visit. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy of plant-based meal replacement system on A1-C levels

Secondary study objectives

Efficacy of plant-based meal replacement system on insulin levels

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment2 Interventions

Replace meals with a plant-based meal replacement and self-prepared Meditteranean meals for a max 1200 calorie per day. Enroll in a 12 week intensive lifestyle intervention program.

Group II: Standard of Care GroupActive Control1 Intervention

Do I qualify?Apply below to find out

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

The most common treatments for Type 2 Diabetes include incretin-based therapies such as GLP-1 receptor agonists and DPP-4 inhibitors, as well as dietary interventions like meal replacement systems. GLP-1 receptor agonists enhance insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety, leading to weight loss and improved glycemic control. DPP-4 inhibitors increase the levels of incretin hormones, which also help regulate blood sugar levels. Meal replacement systems focus on significant weight loss, which is strongly associated with diabetes remission. These treatments are crucial for T2D patients as they address both hyperglycemia and obesity, two key factors in the progression and management of the disease.

Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.Overcoming obstacles in risk factor management in type 2 diabetes mellitus.The changing landscape of type 2 diabetes: the role of incretin-based therapies in managed care outcomes.

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Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

312 Previous Clinical Trials

260,902 Total Patients Enrolled

Warren Peters, MDPrincipal InvestigatorLoma Linda University Health

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Proprietary Meal Replacement System (Meal Replacement System) Clinical Trial Eligibility Overview. Trial Name: NCT05397028 — N/A

Type 2 Diabetes Research Study Groups: Intervention Group, Standard of Care Group

Type 2 Diabetes Clinical Trial 2023: Proprietary Meal Replacement System Highlights & Side Effects. Trial Name: NCT05397028 — N/A

Proprietary Meal Replacement System (Meal Replacement System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397028 — N/A

Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05397028 — N/A

~1 spots leftby Sep 2025

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