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

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

How does the Proprietary Meal Replacement System treatment for type 2 diabetes differ from other treatments?

The Proprietary Meal Replacement System for type 2 diabetes is unique because it focuses on replacing meals rather than using traditional insulin or oral medications. This approach may help manage blood sugar levels by controlling calorie and carbohydrate intake, which is different from other treatments that primarily focus on insulin delivery or enhancing insulin action. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Intensive Lifestyle Intervention, Proprietary Meal Replacement System for Type 2 Diabetes?

Research shows that using meal replacements can help people with type 2 diabetes manage their blood sugar levels and lose weight. Studies found that replacing some meals with diabetes-specific nutritional shakes improved blood sugar control and helped with weight management. ^{6 7 8 9 10}

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

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]

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]

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. United States pubmed.ncbi.nlm.nih.gov

Impact of Partial Meal Replacement on Glycemic Levels and Body Weight in Indian Patients with Type 2 Diabetes (PRIDE): A Randomized Controlled Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

How best to use partial meal replacement in managing overweight or obese patients with poorly controlled type 2 diabetes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Meal Replacement in Patients With Type 2 Diabetes. [2023]

4. United States 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. [2022]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in the Digital Age. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Novel strategy for oral peptide delivery in incretin-based diabetes treatment. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Randomized forced titration to different doses of technosphere insulin demonstrates reduction in postprandial glucose excursions and hemoglobin A1c in patients with type 2 diabetes. [2021]

10. England pubmed.ncbi.nlm.nih.gov

IDegAsp (insulin degludec + insulin aspart) for the management of type 2 diabetes: current status. [2019]