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

Loma Linda University (LLU)

Status: Terminated

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Behavioral: Intensive lifestyle Intervention; Dietary Supplement: Meal replacement system

Study type: Interventional

Funder types: Other

Identifiers

NCT05397028

5200281

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive lifestyle Intervention

Dietary Supplement: Meal replacement system

Standard of Care Group

No Intervention group