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

Not Applicable

Terminated

• Conditions: Obesity; Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Meal replacement system; Behavioral: Intensive lifestyle Intervention

• Registration Number: NCT05397028
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Study Start: 2022-12-08
• Primary Completion: 2023-03-14
• Study Completion: 2023-03-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Intensive lifestyle Intervention	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.
Intervention Group	Meal replacement system	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of plant-based meal replacement system on A1-C levels	Change between baseline and six month visit.	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%.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States