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Meal Replacement System
Meal Replacement System for Type 2 Diabetes (DRS Trial)
N/A
Waitlist Available
Led By Warren Peters, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and six month visit.
Awards & highlights
DRS Trial Summary
This trial is testing a meal replacement system to see if it can help people with Type 2 Diabetes go into remission without the use of medications.
Who is the study for?
This trial is for English-speaking men and women aged 25-65 who have been diagnosed with non-insulin dependent Type 2 Diabetes within the last five years. Participants should be taking oral diabetes medication but not have had recent significant weight loss, bariatric surgery, or use of anti-obesity drugs.Check my eligibility
What is being tested?
The study tests a meal replacement system combined with an intensive lifestyle program over three months to see if it can lead to significant weight loss and help patients achieve diabetes remission without medication.See study design
What are the potential side effects?
Potential side effects may include nutritional deficiencies due to diet changes, gastrointestinal discomfort from new foods in the meal plan, and possible increased hunger or fatigue during the initial adjustment period.
DRS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between baseline and six month visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and six month visit.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of plant-based meal replacement system on A1-C levels
Secondary outcome measures
Efficacy of plant-based meal replacement system on insulin levels
DRS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment2 Interventions
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.
Group II: Standard of Care GroupActive Control1 Intervention
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Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,985 Total Patients Enrolled
Warren Peters, MDPrincipal InvestigatorLoma Linda University Health
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had weight loss surgery.You have taken medications for weight loss in the past three months.You have been diagnosed with an eating disorder.You are currently taking any kind of diabetes pill.You are currently receiving treatment for cancer.You are currently taking a pill for diabetes.You are taking medications that are known to cause weight gain, such as insulin, steroids, and certain psychiatric medications.You have tried to lose a lot of weight in the past 3 months.Your high blood pressure is not well controlled, with diastolic (bottom number) above 90 and systolic (top number) above 160.You must be between 25 and 65 years old.You have been diagnosed with non-insulin dependent diabetes for fewer than five years.You had a heart attack in the last 3 months.You have been diagnosed with non-insulin dependent diabetes for less than five years.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Standard of Care Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05397028 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate amount of individuals taking part in this research?
"Affirmative. According to records accessible via clinicaltrials.gov, this medical trial is continuing its recruitment efforts having been initially posted on August 1st 2022 and last updated on June 28th 2022. As of now, the study requires 50 people from one site."
Answered by AI
What criteria must potential participants meet to be qualified for inclusion in this study?
"This research requires 50 participants aged between 25-65 who suffer from type 2 diabetes mellitus, as well as being male or female and having had the condition for no more than five years. Additionally, it is requisite that all subjects take oral agents to manage their medical condition and are able to converse in English."
Answered by AI
Are individuals over the age of 55 able to participate in this experiment?
"This current trial is enrolling individuals aged 25 and over, but under 65 years old."
Answered by AI
Are there any available slots for participants in this clinical trial?
"Affirmative. According to information publicly available on clinicaltrials.gov, this medical trial is currently accepting applications from participants. The study was initially published on August 1st 2022 and has since been updated as of June 28th 2022; 50 individuals are needed across a single location for enrolment purposes."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
California
How old are they?
65+
What site did they apply to?
Loma Linda University Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
What questions have other patients asked about this trial?
How many times will I need to travel to Loma Linda?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Interested in finding non-medication-based treatment for diabetes 2 and obesity.
PatientReceived no prior treatments
I have lost 20 pounds (210 to 190) this year to work towards a healthier weight and help lower my a1C. I currently take 1000 berberine, 500 cinnamon, and gymnema sylvester 2 a day. Have lowered a1C from 7.4 to 6.6. now stuck, both with a1C and weight loss.
PatientReceived no prior treatments
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