Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS) (DRS)

A three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in Diabetes remission in >30% of intervention subjects

To assess the efficacy of which patients with Type 2 Diabetes (non insulin dependent) can be brought into a optimal A1C remission state without the use of medications by achieving clinically significant weight loss (>20-30 pounds) using a proprietary meal replacement system associated with a 3-month intensive lifestyle program.

Study Overview

• Status: Terminated
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Meal replacement system; Behavioral: Intensive lifestyle Intervention

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and Women
• Ages 25-65
• Have been diagnosed with non-insulin dependent diabetes for less than five years
• Are taking at least one oral agents for diabetes
• English speaking

Exclusion Criteria:

• Individuals currently being treated for cancer
• Had a myocardial infarction in the previous 3 months
• Have uncontrolled persistent hypertension - diastolic >90 systolic >160
• Individuals with established eating disorder diagnoses
• Individuals who have recent weight loss attempt in the last 3 months with > 5-pound loss
• Use of anti-obesity medications in the last three months
• Individuals who have had bariatric surgery
• Individuals taking medications that are known to cause weight gain including but not limited to insulin, steroids, haloperidol clozapine, risperidone, olanzapine, amitriptyline imipramine, paroxetine, and lithium
• Individuals who are pregnant or planning to become pregnant in the next 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Dietary supplement: Meal replacement system; Participants will replace meals with a meal replacement system to assess the efficacy of weight loss leading to remission of diabetes (optimal A1C levels).; Behavioral: Intensive lifestyle Intervention; Participants will sign up with a virtual health program which they will interact with.
No Intervention: Standard of Care Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of plant-based meal replacement system on A1-C levels	Blood draw to measure the effect of the diet on the A1-C level. Normal A1C is at or below 5.7%. Prediabetes levels range between 5.8%-6.4%. Diabetes is at or above 6.5%.	Change between baseline and six month visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of plant-based meal replacement system on insulin levels	Blood draw to measure the effect of the diet on fasting insulin. Insulin levels under the value 10 are considered normal.	Change between baseline and six month visit.

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Warren Peters, MD, Loma Linda University Health

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Actual): March 14, 2023
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: obesity; meal replacement; Diabetes, Type 2; diabetes remission
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 5200281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No