Your session is about to expire
← Back to Search
Behavioural Intervention
Very Low Calorie Diet for Obesity
Phase 2 & 3
Waitlist Available
Led By Moahad Dar, MD
Research Sponsored by Durham VA Medical Center
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 baseline, week 12, week 24, week 48
Awards & highlights
Study Summary
"This trial aims to find a way to achieve the positive effects of gastric bypass surgery on weight loss and blood sugar control without actually undergoing surgery. The researchers believe that a combination of a medically supervised diet program
Who is the study for?
This trial is for individuals with obesity and type 2 diabetes who are looking for an alternative to bariatric surgery. Participants should be interested in a medically supervised diet combined with medication that mimics the effects of gastric bypass surgery.Check my eligibility
What is being tested?
The study tests if a very low calorie diet (Optifast) along with a weekly injectable GLP-1 medicine can replicate the weight loss and blood sugar control benefits typically seen after Roux-en-Y gastric bypass surgery in patients with type 2 diabetes.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to the drastic change in diet, reactions at injection sites from the GLP-1 medicine, and possible changes in blood sugar levels that need close monitoring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12, week 24, week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, week 24, week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic Control
Secondary outcome measures
Health Related Quality of Life
Medication Intensity
Weight lost
Other outcome measures
Symptom Item Checklist
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Very Low Calorie DietExperimental Treatment1 Intervention
Patients in the experimental group will attend 4 in-person visits with the study coordinator at baseline, week 12, week 24, and week 48 to measure study outcomes. Additionally, they will undergo a 2 week run-in phase before baseline with weekly meetings to ensure that they are able to tolerate and comply with Optifast.
Patients will get medical drug management (endocrinologist), nutritional/behavioral counseling (dietician, psychologist) and will be maintained on Optifast + once weekly GLP-1 agonist +/- other diabetic medicines.
Group II: Standard of CareActive Control1 Intervention
Patients in the control group will attend four in-person visits with the study coordinator at baseline, week 12, week 24, and week 48 to measure study outcomes.
Patients will get medical drug management (endocrinologist), nutritional/behavioral counseling (dietician, psychologist) and will be maintained on once weekly GLP-1 agonist +/- other diabetic medicines.
Find a Location
Who is running the clinical trial?
Durham VA Medical CenterLead Sponsor
38 Previous Clinical Trials
9,274 Total Patients Enrolled
Société des Produits Nestlé (SPN)Industry Sponsor
337 Previous Clinical Trials
62,515 Total Patients Enrolled
9 Trials studying Obesity
790 Patients Enrolled for Obesity
Moahad Dar, MDPrincipal InvestigatorDepartment of Veteran Affairs
1 Previous Clinical Trials
5 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would it be possible for me to participate in this medical study?
"Individuals aged between 25 and 75 with a diagnosis of obesity are eligible to participate in this clinical research. Approximately 50 participants will be enrolled in the trial."
Answered by AI
Is there an age limit for participation in this research study?
"Eligible participants for this research must fall within the age bracket of 25 to 75. It's interesting to note that there are a substantial number of trials catering specifically to individuals under 18 and over 65 years old, with figures reaching 214 and 1346 respectively."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger