Back to resultsWeight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS) (DRS)
Primary Purpose
Obesity, Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal replacement system
Intensive lifestyle Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, Diabetes, Type 2, meal replacement, diabetes remission
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
Sites / Locations
- Loma Linda University HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Standard of Care Group
Arm 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.
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05397028
Brief Title
Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)
Acronym
DRS
Official Title
Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2024 (Anticipated)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes Mellitus, Type 2
Keywords
obesity, Diabetes, Type 2, meal replacement, diabetes remission
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Meal replacement system
Intervention Description
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
Behavioral
Intervention Name(s)
Intensive lifestyle Intervention
Intervention Description
Participants will sign up with a virtual health program which they will interact with.
Primary Outcome Measure Information:
Title
Efficacy of plant-based meal replacement system on A1-C levels
Description
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%.
Time Frame
Change between baseline and six month visit.
Secondary Outcome Measure Information:
Title
Efficacy of plant-based meal replacement system on insulin levels
Description
Blood draw to measure the effect of the diet on fasting insulin. Insulin levels under the value 10 are considered normal.
Time Frame
Change between baseline and six month visit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Warren Peters, MD
Phone
909-558-4594
Email
wpeters@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Kerichenko, BS
Phone
909-558-4920
Email
lkerichenko@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Peters, MD
Organizational Affiliation
Loma Linda University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Warren Peters, MD
Phone
909-558-4920
Email
wpeters@Llu.edu
First Name & Middle Initial & Last Name & Degree
Lindsay Kerichenko, BS
Phone
909-558-4920
Email
lkerichenko@llu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)
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