Bariatric Surgery vs. Medication for Type 2 Diabetes
(ST2OMP Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Children's Hospital Medical Center, Cincinnati
Must not be taking: Oral steroids, Pancreatotoxic drugs
Disqualifiers: Type 1 diabetes, Chronic kidney disease, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study will test the hypothesis that metabolic bariatric surgery will be more effective at providing durable glycemic control and reduce co-morbidities than intensive medical therapy in youth with type 2 diabetes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using chronic oral steroids or pancreatotoxic drugs. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of this treatment for type 2 diabetes?
Research shows that bariatric surgery, including procedures like Roux-en-Y gastric bypass and biliopancreatic diversion, is more effective than medication for improving or even reversing type 2 diabetes, especially in patients with severe obesity. However, these surgeries can have significant complications, and their long-term benefits compared to medical treatments need further study.
12345Is bariatric surgery generally safe for humans?
Bariatric surgery, including procedures like gastric bypass and sleeve gastrectomy, has improved in safety over the years with low complication rates and mortality. However, it can still have significant surgical and nutritional complications, so the benefits and risks should be carefully considered.
23467How is bariatric surgery different from other treatments for type 2 diabetes?
Bariatric surgery is unique because it not only helps with weight loss but also significantly improves or even resolves type 2 diabetes, especially in obese patients, more effectively than standard medical treatments like diet and medication. It involves surgical procedures like gastric bypass or sleeve gastrectomy, which alter the digestive system to aid in weight loss and improve blood sugar control.
128910Eligibility Criteria
This trial is for young people aged 13-19.9 with type 2 diabetes who meet the criteria for bariatric surgery and have not had previous weight-loss surgeries. They should not have other types of diabetes, serious kidney or liver diseases (except NAFLD or DKD), be on chronic oral steroids recently, be pregnant, breastfeeding, planning to get pregnant, or taking drugs harmful to the pancreas.Inclusion Criteria
I have been diagnosed with Type 2 diabetes.
I am medically recommended to undergo weight loss surgery.
You do not have certain antibodies associated with diabetes.
+1 more
Exclusion Criteria
I have had weight loss surgery in the past.
Other conditions, that in the determination of the study investigator, may interfere with study participation
I have chronic kidney or liver disease, but not due to fatty liver or diabetes.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either vertical sleeve gastrectomy (VSG) or advanced medical therapy (AMT) to manage type 2 diabetes
1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on glycemic control and T2D-associated comorbidities
1-2 years
Long-term Follow-up
Participants are monitored for long-term outcomes such as hypertension, beta cell function, and diabetic kidney disease
2 years
Participant Groups
The study aims to see if metabolic bariatric surgery is better than intensive medical therapy at controlling blood sugar levels and reducing related health problems in youths with type 2 diabetes.
3Treatment groups
Active Control
Group I: Bariatric Surgery in Youth with ObesityActive Control1 Intervention
Youth with no obesity undergoing bariatric surgery, n=10
Group II: Medical Therapy and Bariatric Surgery in Youth with Type 2 DiabetesActive Control1 Intervention
Youth with type 2 diabetes undergoing bariatric surgery, n=45
Group III: Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 DiabetesActive Control1 Intervention
Youth with type 2 diabetes receiving medical management, n=45
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lurie Children's HospitalChicago, IL
Cincinnati ChildrensCincinnati, OH
Children's Hospital ColoradoAurora, CO
Loading ...
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
Children's Hospital ColoradoCollaborator
References
The role of bariatric surgery in the treatment of type 2 diabetes mellitus. [2012]Medical treatments for patients with type 2 diabetes mellitus and class II and above obesity (body mass index greater than 35 kg/m2) are currently limited to treatment of diabetes and prevention of its vascular complications. Bariatric surgery is by far the most effective treatment not only for weight loss, but also for improvement or remission of diabetes. This editorial examines the current evidence for the impact of bariatric surgery on weight loss and type 2 diabetes.
A nationwide safety analysis of bariatric surgery in nonseverely obese patients with type 2 diabetes. [2022]Bariatric surgery is more effective than medical therapy in treatment of type 2 diabetes (T2D) in patients with severe obesity. However, surgery is often not advocated for patients with T2D who are overweight or have mild obesity.
Bariatric surgery versus conventional medical therapy for type 2 diabetes. [2022]Roux-en-Y gastric bypass and biliopancreatic diversion can markedly ameliorate diabetes in morbidly obese patients, often resulting in disease remission. Prospective, randomized trials comparing these procedures with medical therapy for the treatment of diabetes are needed.
Metabolic surgery for type 2 diabetes: appraisal of clinical evidence and review of randomized controlled clinical trials comparing surgery with medical therapy. [2021]Bariatric surgical procedures were originally developed to treat morbid obesity where their benefits certainly outweigh their potential side effects. Although they are very beneficial in improving metabolic control in type 2 diabetes, there are many medical treatments that are also effective. The role of bariatric surgery as primary therapy for type 2 diabetes depends on whether the benefit exceeds the surgical and nutritional complications, which are significant. The ultimate role for bariatric surgery in treating type 2 diabetes can only be determined by large, long-term randomized clinical trials which compare clinical outcomes of bariatric surgery with those of current intensive medical treatment. The four reported small, mostly 1-year trials have shown superior glycemic control by surgery as compared with medical treatment, but at the expense of significant surgical complications and unknown nutritional liability. They show that future trials will have to be much larger and last for at least 5-10 years.
Ten-year remission rates in insulin-treated type 2 diabetes after biliopancreatic diversion with duodenal switch. [2021]Biliopancreatic diversion with duodenal switch (BPD-DS) confers the highest rate of type 2 diabetes (T2D) remission compared with other bariatric procedures. Previous studies suggest that type of antidiabetic therapy used before surgery and duration of disease influence postsurgical glycemic outcomes. Short-term, progressive improvement in insulin sensitivity and beta-cell function after metabolic surgery in patients with noninsulin-treated T2D has been demonstrated. Whether patients with more advanced disease can achieve sustained remission remains unclear.
Bariatric surgery vs. advanced practice medical management in the treatment of type 2 diabetes mellitus: rationale and design of the Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently trial (STAMPEDE). [2021]Obesity and Type 2 diabetes mellitus (T2DM) are closely interrelated, and are two of the most common chronic, debilitating diseases worldwide. Surgical approaches to weight loss (bariatric surgery) result in marked improvement of T2DM, however randomized trials directly comparing the efficacy of surgical and medical approaches are lacking. The Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial was designed to evaluate the efficacy of two bariatric surgery procedures involving gastric restriction only (laparascopic sleeve gastrectomy) and gastric bypass (Roux-en-Y) to advanced medical therapy in patients with T2DM with modest obesity with BMI of 27-42 kg/m2. This single site, prospective, randomized controlled trial will enroll 150 subjects who will be followed. The primary end point will be the rate of biochemical resolution of T2DM at 1 year as measured by HbA1c
Bariatric surgery in patients with type 2 diabetes: a viable option. [2011]The prevalence of obesity is increasing and is co-epidemic with type 2 diabetes mellitus (T2DM). Treatment of obesity has been less than adequate, particularly when managing morbidly obese patients. Research on T2DM has shown a number of new pharmacologic therapies along with the rapid employment of bariatric surgery. Improvement of T2DM, including its remission, after bariatric surgery has been recognized for more than a decade. However, not all procedures are the same. Restrictive procedures, malabsorptive procedures, or a combination of both procedures have their own categorical risks and benefits. Which procedure to choose has to do with many patient selection factors, notwithstanding insurance coverage. Based on operative and postoperative mortality data, laparoscopically assisted gastric bypass (LAGB) has been shown to be the safest bariatric surgery procedure. However, the Roux-en-Y gastric bypass procedure is one of the most widely used for obese patients with T2DM. The mechanisms involved in weight loss and improved blood glucose control appear to involve increased insulin sensitivity, decreased lipotoxicity/inflammation, and changes in gut hormones/incretins. The safety of bariatric procedures has improved; complication rates are low and mortality is
Bariatric surgery or medicine for type 2 diabetes? [2018]Diet and medical treatment are the standard treatment for type 2 diabetes. In obese subjects with type 2 diabetes, bariatric surgery is effective in resolving diabetes. Two clinical trials comparing bariatric surgery to medical treatment were evaluated. Both the Surgical Treatment And Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial (laparoscopic Roux-En Y gastric bypass and sleeve gastrectomy) and the DIet and medical therapy versus BAriatric SurgerY in type 2 diabetes (DIBASY) trial (laparoscopic gastric bypass and biliopancreatic-diversion) showed that surgery was more effective than medical care in resolving or managing type 2 diabetes. Larger studies, or a compilation of studies, are needed to determine whether one of these procedures is better, or if they are all similarly effective, and this should also be weighed against the risk of the operations.
Laparoscopic sleeve gastrectomy with duodenojejunal bypass for the treatment of type 2 diabetes in non-obese patients: technique and preliminary results. [2022]Medical treatment of type 2 diabetes has often insufficient clinical results at long term. Although the surgical option is a well-established alternative for obese patients, the procedures in non-obese are currently being developed.
Partial jejunal diversion using an incisionless magnetic anastomosis system: 1-year interim results in patients with obesity and diabetes. [2022]Most patients with type 2 diabetes mellitus have obesity. Studies show that bariatric surgery is superior to medical treatment for remission of type 2 diabetes mellitus. Nevertheless, very few patients undergo surgery, and a less-invasive endoscopic alternative is desirable.