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

Sponsor

Loma Linda University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05397028

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Diabetes Mellitus, Type 2	Dietary Supplement: Meal replacement system Behavioral: Intensive lifestyle Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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