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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
No Placebo-Only Group

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 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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.

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
314 Previous Clinical Trials
266,537 Total Patients Enrolled
Warren Peters, MDPrincipal InvestigatorLoma Linda University Health
1 Previous Clinical Trials
119 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 Oct 2025