Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363747
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-09
Brief Title:
The Medically Reproducing Bariatric Surgery MRB II Study
Sponsor:
Durham VA Medical Center
Organization:
Durham VA Medical Center
Study Overview
Official Title:
The Medically Reproducing Bariatric Surgery MRB II Study SEMAGLUTIDE Followed by OPTIFAST in Veterans With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Roux-en-Y RYGB gastric bypass reduces the size and capacity of the stomach and bypasses a portion of the small intestine which leads to decreased food intake and higher levels of a gut hormone called GLP-1 glucagon-like-peptide-1 These changes lead to weight loss improved blood sugars and often remission of type 2 diabetes but most patients do not qualify or want surgery The investigators are searching for ways to make the beneficial effects of RYGB available to most type 2 diabetes patients rather than a select few that undergo RYGB
The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes Normal meals are then gradually reintroduced over 6 weeks and the barsshakes are stopped The investigators hypothesize that Optifast diet once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB
The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes Normal meals are then gradually reintroduced over 6 weeks and the barsshakes are stopped The investigators hypothesize that Optifast diet once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB
Detailed Description:
MRB II is a two arm 50-week study that will recruit Veteran DM2 patients already on a stable dose of a GLP-1 agonist - DM2 agents The investigators will recruit 50 patients and assign 25 subjects to the control arm and 25 subjects to the experimental arm The control and experimental arm n25 will have in-person visits with the study PI certified diabetes educator CDE and behavioral psychologist Psych at baseline week 12 week 24 and week 48 to optimize glycemic control Visits with the PI will be one-on-one but visits with CDEPsych will be shared-medical appointments Furthermore the experimental arm n25 will also be enrolled in the Optifast medical weight loss program starting with a 2-week run-in phase to determine if they are able to tolerate Isocaloric Optifast 7 meal replacementsday while also minimizing significant weight loss prior to the start of the study The patients in the experimental arm successfully completing the run-in phase will then continue and enter the 50-week study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None