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

NCT ID: NCT05397028

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2023-03-14

Brief Summary

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.

Conditions

Obesity; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Meal replacement system

Intervention Type: DIETARY_SUPPLEMENT

Participants will replace meals with a meal replacement system to assess the efficacy of weight loss leading to remission of diabetes (optimal A1C levels).

Intensive lifestyle Intervention

Intervention Type: BEHAVIORAL

Participants will sign up with a virtual health program which they will interact with.

Standard of Care Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Intensive lifestyle Intervention

Participants will sign up with a virtual health program which they will interact with.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Warren Peters, MD, MPH

Director, Center for Health Promotion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Warren Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Health

Locations

Loma Linda University Health

Loma Linda, California, United States

Countries

United States

Other Identifiers

5200281

Identifier Type: -

Identifier Source: org_study_id