Meal Replacement System for Type 2 Diabetes

(DRS Trial)

Overseen By Warren Peters, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must be taking: Oral diabetes agents

Must not be taking: Insulin, Steroids, Antipsychotics, others

Disqualifiers: Cancer, Myocardial infarction, Hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a special meal replacement system (Proprietary Meal Replacement System) can help individuals with Type 2 Diabetes achieve remission without medication through significant weight loss. Participants will follow a 3-month program that includes plant-based meal replacements and self-prepared Mediterranean meals, totaling no more than 1200 calories per day. Ideal participants are those diagnosed with non-insulin dependent diabetes for less than five years and currently taking oral diabetes medications. As an unphased trial, this study provides participants the opportunity to explore innovative dietary approaches to diabetes management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current diabetes medications, but it aims to achieve diabetes remission without the use of medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this meal replacement system is safe for individuals with Type 2 Diabetes?

Research shows that meal replacements can safely and effectively manage Type 2 Diabetes. Studies have found that these products often help people lose significant weight and improve their health. For instance, one study discovered that people using meal replacements lost 31.5% more weight than those on regular diets.

Regarding safety, meal replacements are usually well-tolerated. A study that combined results from several studies on people with Type 2 Diabetes found that meal replacements are safe for most, with serious side effects being rare.

Moreover, meal replacements have helped some people achieve diabetes remission, meaning their blood sugar levels returned to a healthier range. Specifically, one study found that 36% of participants using meal replacements reached remission.

Overall, meal replacements are considered safe and can be a useful tool for managing Type 2 Diabetes, especially when combined with lifestyle changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the proprietary meal replacement system for Type 2 diabetes because it offers a unique approach to managing the condition. Unlike standard treatments that often focus on medication, this system emphasizes dietary changes by incorporating plant-based meal replacements alongside self-prepared Mediterranean meals, all within a calorie-restricted plan. This method not only targets weight management, a critical factor in diabetes control, but also promotes a healthier lifestyle through a 12-week intensive lifestyle intervention program. The combination of these elements has the potential to improve blood sugar levels and overall health more effectively than traditional medication alone.

What evidence suggests that this meal replacement system is effective for Type 2 Diabetes?

Research has shown that meal replacements can effectively manage Type 2 Diabetes. In this trial, participants in the Intervention Group will replace meals with a plant-based meal replacement and self-prepared Mediterranean meals as part of a 12-week intensive lifestyle intervention program. Studies have found that these portion-controlled meals can lead to 31.5% more weight loss compared to other diets. Specifically, one study showed that 36% of people using meal replacements experienced diabetes remission, with blood sugar levels returning to normal. Another study found that meal replacements significantly lowered both HbA1c levels (a measure of long-term blood sugar control) and fasting blood sugar levels. These findings suggest that meal replacements can be a promising way to achieve significant weight loss and possibly put Type 2 Diabetes into remission. ^{1 2 3 4 6}

Who Is on the Research Team?

Warren Peters, MD

Principal Investigator

Loma Linda University Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Men and Women

You are currently taking any kind of diabetes pill.

You are currently taking a pill for diabetes.

Exclusion Criteria

You have had weight loss surgery.

You have taken medications for weight loss in the past three months.

You have been diagnosed with an eating disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a 3-month meal replacement dietary system combined with self-prepared meals and a 12-week intensive lifestyle intervention program

12 weeks

Follow-up

Participants are monitored for changes in A1C and insulin levels after the treatment phase

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Lifestyle Intervention
• Proprietary Meal Replacement System

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 2 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 Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

In a pilot study involving 81 adults with type 2 diabetes, using a diabetes-specific nutritional shake (DSNS) as a breakfast replacement led to significantly greater reductions in postprandial glycemic response compared to those who maintained their usual diets.

Participants who consumed DSNS not only improved their glycemic control but also reported reduced cravings for starchy foods and increased confidence in managing their diabetes through dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study. Mustad, VA., Hegazi, RA., Hustead, DS., et al.[2021]

Meal replacement (MR) significantly improves glycemic control and reduces body weight in type 2 diabetes (T2D) patients compared to conventional diabetic diets, with a notable reduction in HbA1c by 0.46% and body weight by 2.43 kg based on a meta-analysis of 17 randomized controlled trials involving 2112 participants.

Total meal replacement with caloric restriction showed the greatest benefits, leading to a more significant reduction in HbA1c, fasting blood glucose, and body weight, indicating that both total MR and appropriate calorie restriction are effective strategies for managing T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Meal Replacement in Patients With Type 2 Diabetes. Ye, W., Xu, L., Ye, Y., et al.[2023]

In a study involving 119 participants with type 2 diabetes, a portion-controlled meal replacement diet (PCD) led to significantly greater weight loss at 34 weeks compared to a standard diet (SD), with about 40% of PCD participants losing at least 5% of their initial weight versus only 12% in the SD group.

The PCD not only resulted in better weight loss but also showed higher retention rates and easier adherence among participants, suggesting it could be a more effective strategy for long-term weight management in obese patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of meal replacements versus a standard food-based diet for weight loss in type 2 diabetes: a controlled clinical trial. Cheskin, LJ., Mitchell, AM., Jhaveri, AD., et al.[2022]

The OmniPod® Insulin Management System is the first commercially available patch pump, offering a fully integrated and wireless insulin delivery solution that includes a built-in blood glucose meter.

This review highlights the OmniPod's advantages over traditional insulin pumps, including its potential use in advanced diabetes management projects like the Juvenile Diabetes Research Foundation's Artificial Pancreas Project.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OmniPod Insulin Management System: the latest innovation in insulin pump therapy. Zisser, HC.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686729/

Meal replacement in dietary management of type-2 ... It is found out that portion-controlled MR is able to produce 31.5% more clinically significant weight loss (> 5% weight loss 1 year) and significant BMI ...

2. wjgnet.com wjgnet.com/1948-9358/full/v16/i8/104371.htm

A systematic scoping review of meal replacements in type ... These results emphasize meal replacements as a promising tool in diabetes management, with implications for improving patient outcomes and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9366088/

Meal Replacements for Weight-Related Complications in ... At 24 months, 36% of patients in the intervention group had diabetes remission compared with 3% in the control group (15). These findings are ...

4. academic.oup.com academic.oup.com/jcem/article-abstract/108/11/3041/7165429

Efficacy and Safety of Meal Replacement in Patients With ... Compared with CDs, MR significantly reduced glycated hemoglobin A1c (HbA1c) (MD −0.46%; P < .001), fasting blood glucose (FBG, −0.62 mmol/L; P < .001), body ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.01.20.25320837v1.full-text

Evaluating Diabetes-Specific Meal Replacements for ... Glycaemic control and obesity indicators are the study's main outcomes. Secondary outcomes include cardiovascular disease risk marker, metabolic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05110703

Study to Assess Safety and Effect of a Prebiotic Fiber Meal ... This study is a double-blind, randomized, trial of a commercially available meal-replacement shake versus a placebo control designed to evaluate the impact ...