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RecruitingPhase 4

Impact GLP-1 Agonists Following Bariatric

Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits, 6 visits
  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study Procedures/ Design/ Treatment Plan: Patients will be recruited for approximately 5 years to gather the appropriate sample size."
  • "Because each patient will have samples collected for 5 years, it will be approximately 10 years from last patient enrolled until study is completed."
  • "Data from these visits will be used for the research study * Blood will be drawn at 3 month visit, 6 month visit and annual visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether staying on or stopping a GLP-1 medicine after weight-loss surgery changes weight, blood sugar, eating habits, and side effects. GLP-1 medicines help control blood sugar and hunger. The study is for adults already taking one of these medicines who plan to have weight-loss surgery at MU Health Care.

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 randomized trial, the effects of continuation or discontinuation of GLP1-RA therapy in patients undergoing bariatric surgery will be determined. We will compare changes in weight, metabolic determinants including circulating bile acids and gut microbiome, psychological determinants of eating behavior, and adverse side effects in patients who continue vs discontinue therapy. Given differences in metabolic and clinical outcomes in patients undergoing vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB), both surgical groups will be examined. The study will be conducted at a high volume bariatric surgical program where patients will undergo randomization at the time of final clinic visit prior to surgery to continue or discontinue GLP1-RA. It is hypothesized that participants who continue GLP1-RA therapy after bariatric surgery will lose more weight with improved blood glucose control than those who discontinue therapy. Furthermore, changes in gut microbiome and circulating bile acids, known determinants of metabolic health, will be modified to a differential extent in those who are on GLP1-RAs vs those where GLP1-RAs are discontinued. Understanding the role these medications play in not only clinical outcomes after metabolic surgery but potential metabolic mechanisms by which surgery improves patient's metabolic health could help people with obesity and type 2 diabetes make informed decisions about their treatment options as well as advise providers on the continuation of these medications in the perioperative and postoperative period.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18.
  • Receive care from an MU Health Care surgeon and have weight-loss surgery through its Weight Management and Metabolic Center.
  • Have a body mass index (BMI), a measure of weight compared with height, from 30 to 80.
  • Qualify for insurance coverage for weight-loss surgery or pay for it yourself.
  • Plan to have a Roux-en-Y gastric bypass, sleeve surgery, duodenal switch or a modified version, or surgery to change an earlier weight-loss surgery.
  • Already take a GLP-1 medicine as part of your regular medical care.
  • You and your care team must agree to follow a group assignment made by chance to stay on or stop the medicine after surgery. If you decline this assignment, you may still join without being assigned by chance.
  • Agree to blood draws before and after surgery, or at least to having health information collected and stored in a study database. Other samples are optional.

Who can't join

  • Be pregnant.
  • Not want to join the study.
  • Be younger than 18.
  • Not qualify for insurance coverage and not want to pay for surgery yourself.
  • Not take a GLP-1 medicine as part of your regular care.
  • Not agree to attend required visits after surgery.
  • Not agree to stay on or stop the medicine based on your assigned group. You may still join without being assigned by chance.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

MO