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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Meal replacement system
* Behavioral: Intensive lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, Diabetes, Type 2, meal replacement, diabetes remission