💬In plain words
What the trial is, and whether it could suit you
Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariatric surgical procedures have been shown to be effective in treating obesity as well as superior to best medical therapy for treatment of diabetes not just through restriction of calories but also through a positive impact in modifications of gut hormones, changes in circulating bile acids, modifications in the gut microflora as well as other undefined mechanisms. The combined benefits of GLP1-RAs with bariatric surgery have only been studied to a limited effect. In this rando
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Greater than 18 years of age
2. Participation in care by one of the surgeons at MU Health Care
3. Undergoing surgical weight loss through the Weight Management and Metabolic Center
4. Body mass index of 30-80 kg/m2
5. Meet insurance criteria, as set forth by the patient's insurance policy, to qualify for coverage for weight loss surgery or as a self-pay patient for the weight loss procedure
6. Planned laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, revisional weight loss surgery, or duodenal switch or modification of. If patients are not willing to be randomized they will not be enrolled as randomized but can still participate having samples collected.
7. Willingness to have blood collected before and after surgical procedure at defined points or at minimum have clinical data collected.
8. Willingness to have clinical data entered into a prospective database
9. Additional specimens collected as stated in the protocol will be offered but collection not mandated.
5\. Taking a GLP-1 agonist as part of their routine medical care apart from any planned surgical procedure. The current standard of care regarding continuation or discontinuation of GLP-1 agonists has not been established and is at the discretion of members of the patient's medical team but to be included the patient and medical care team must be willing to continue or discontinue the GLP-1 agonist after surgery depending on the randomized group.
Exclusion Criteria:
1. Pregnant patient
2. Desire to not participate
3. Age less than 18
4. Patient fails to fulfill insurance mandated criteria and is not interested in paying cash for their procedure
5. Not taking a GLP-1 agonist as part of standard medical care
6. Unwilling to follow-up at required postoperative visits
7. Unwilling to stop GLP-1 agonist if randomized into group to stop GLP-1 agonist or unwilling to continue the GLP-1 agonist if randomized into that respective group. If chooses to continue or discontinue the medication apart from randomization the patient can still participate as a non-randomized participant
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