Bariatric Surgery vs. Medication for Type 2 Diabetes

(ST2OMP Trial)

Not currently recruiting at 2 trial locations

Overseen By Kristen J Nadeau, MD

Age: < 65

Sex: Any

Trial Phase: Phase 4

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bariatric surgery can better control blood sugar and reduce health issues in young people with type 2 diabetes compared to medication. Participants will either undergo surgery or receive advanced medical therapy (a comprehensive medication regimen) to determine which approach is more effective. Teens aged 13 to 19 with type 2 diabetes and no diabetes-related antibodies may be suitable for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits a broader range of patients.

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 is the safety track record for these treatments?

Research has shown that bariatric surgery is generally well-tolerated, with a low rate of complications. It effectively supports long-term weight loss and diabetes management. Patients often experience fewer serious health issues related to obesity. The surgery is considered safe, with a low risk of severe side effects.

Previous research also shows that advanced medical therapy is typically safe and well-received by patients. They find the treatment satisfactory and are willing to continue with it. This therapy focuses on controlling blood sugar levels and managing diabetes-related health problems.

Both treatments have been tested and show promise in improving health without significant safety concerns. Participants in these studies usually report positive experiences with few negative effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer new hope for managing type 2 diabetes in young people. Bariatric surgery isn't just about losing weight; it can dramatically improve insulin sensitivity and potentially lead to remission of diabetes, which is a game-changer compared to typical medication management. Meanwhile, advanced medical therapy aims to optimize diabetes control with less invasive methods than surgery, potentially offering a safer alternative with fewer risks. Both approaches could redefine how we tackle type 2 diabetes in youth, focusing not only on managing symptoms but also on altering the course of the disease.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that weight-loss surgery is highly effective for long-term weight loss and improving type 2 diabetes. Studies indicate that surgeries like Roux-en-Y gastric bypass can help individuals lose up to 80% of their excess weight and significantly enhance diabetes management. In this trial, one group of participants will undergo bariatric surgery, while another group will receive advanced medical therapy. Evidence suggests that combining advanced medical treatment with weight-loss surgery results in better blood sugar control than medical treatment alone. Long-term studies have found that more patients experience diabetes remission when both surgery and medical treatment are used together, compared to just medical treatment. Overall, both approaches have demonstrated strong potential in managing type 2 diabetes, especially when combined. ^{1 6 7 8 9}

Who Is on the Research Team?

Amy Shah, MD

Principal Investigator

Cincinnati Childrens Hospital Medical Center

Kristen J Nadeau, MD

Principal Investigator

Children's Hospital Colorado

Michael A Helmrath, MD MS

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Thomas H Inge, MD PhD

Principal Investigator

Lurie Children's Hospital

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I have had weight loss surgery in the past.

I have chronic kidney or liver disease, but not due to fatty liver or diabetes.

Other conditions, that in the determination of the study investigator, may interfere with study participation

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Advanced Medical Therapy
• Bariatric Surgery

Trial Overview 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.

How Is the Trial Designed?

Group I: Bariatric Surgery in Youth with Obesity Active Control 1 Intervention

Youth with no obesity undergoing bariatric surgery, n=10

Group II: Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes Active Control 1 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 Diabetes Active Control 1 Intervention

Youth with type 2 diabetes receiving medical management, n=45

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Published Research Related to This Trial

In a study of 60 severely obese patients with type 2 diabetes, those who underwent gastric bypass or biliopancreatic diversion experienced significantly higher rates of diabetes remission (75% and 95%, respectively) compared to 0% in the medical therapy group after 2 years.

Both surgical procedures led to greater improvements in glycated hemoglobin levels, with the biliopancreatic diversion group achieving an average level of 4.95%, indicating superior glucose control compared to medical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric surgery versus conventional medical therapy for type 2 diabetes. Mingrone, G., Panunzi, S., De Gaetano, A., et al.[2022]

Bariatric surgery is the most effective treatment for patients with type 2 diabetes and obesity (BMI > 35 kg/m2), leading to significant weight loss and improvement or remission of diabetes.

Current medical treatments primarily focus on managing diabetes and preventing complications, highlighting the superior outcomes of bariatric surgery compared to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of bariatric surgery in the treatment of type 2 diabetes mellitus. Leong, WB., Taheri, S.[2012]

The STAMPEDE trial aims to compare the effectiveness of two types of bariatric surgery (sleeve gastrectomy and gastric bypass) against advanced medical therapy in treating Type 2 diabetes in patients with modest obesity (BMI 27-42 kg/m²).

The primary goal of the study is to determine the rate of biochemical resolution of Type 2 diabetes after one year, specifically looking for HbA1c levels below 6%, while also assessing the safety and adverse events associated with each treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Kashyap, SR., Bhatt, DL., Schauer, PR.[2021]

Bariatric surgery, particularly laparoscopically assisted gastric bypass (LAGB), is recognized as the safest option for treating obesity in patients with type 2 diabetes mellitus (T2DM), with low complication rates and mortality under 1%.

The Roux-en-Y gastric bypass is widely used and has been shown to improve blood glucose control through mechanisms like increased insulin sensitivity and changes in gut hormones, highlighting the need for careful patient selection to ensure candidates are appropriate for the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric surgery in patients with type 2 diabetes: a viable option. Colucci, RA.[2011]

Bariatric surgery is a safe and effective option for patients with type 2 diabetes and mild obesity, showing low rates of major complications (≤0.5%) and a 30-day postoperative morbidity rate of 4.2% based on a study of 1300 patients.

Both Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) have similar early postoperative morbidity rates, and smoking is identified as a significant modifiable risk factor for complications following surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nationwide safety analysis of bariatric surgery in nonseverely obese patients with type 2 diabetes. Aminian, A., Andalib, A., Khorgami, Z., et al.[2022]

Bariatric surgery, specifically laparoscopic Roux-En Y gastric bypass and sleeve gastrectomy, has been shown to be more effective than standard medical treatment in resolving type 2 diabetes in obese patients, as demonstrated in the STAMPEDE and DIBASY trials.

Further research is needed to compare the effectiveness of different surgical procedures and to assess their risks, as current studies indicate that surgery generally outperforms medical management for diabetes resolution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric surgery or medicine for type 2 diabetes? Doggrell, SA., Chan, V.[2018]

Bariatric surgery can significantly improve metabolic control in type 2 diabetes, but its role as a primary treatment must be weighed against potential surgical and nutritional complications.

Current evidence from small, short-term trials suggests that while surgery may offer better glycemic control than medical treatments, larger and longer-term studies (5-10 years) are needed to fully understand the benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic surgery for type 2 diabetes: appraisal of clinical evidence and review of randomized controlled clinical trials comparing surgery with medical therapy. Lebovitz, HE.[2021]

In a 12-month study of 10 non-obese patients with type 2 diabetes, laparoscopic sleeve gastrectomy with duodenojejunal bypass led to significant reductions in fasting blood glucose and HbA1c levels, indicating improved diabetes control.

The procedure resulted in an average BMI reduction of 12.1%, although one patient experienced complications, highlighting the need for further research with larger groups to assess long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic sleeve gastrectomy with duodenojejunal bypass for the treatment of type 2 diabetes in non-obese patients: technique and preliminary results. Navarrete, SA., Leyba, JL., Llopis, SN.[2022]

The incisionless magnetic anastomosis system (IMAS) successfully created a partial jejunal diversion in all 10 patients with obesity and type 2 diabetes, with no serious adverse events reported, indicating a safe and feasible approach.

Patients experienced an average weight loss of 14.6% and significant reductions in glycated hemoglobin levels, suggesting effective management of diabetes and obesity without the need for intensive lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial jejunal diversion using an incisionless magnetic anastomosis system: 1-year interim results in patients with obesity and diabetes. Machytka, E., Bužga, M., Zonca, P., et al.[2022]

In a study of 141 insulin-treated patients with type 2 diabetes who underwent biliopancreatic diversion with duodenal switch (BPD-DS), 68.1% achieved complete remission of diabetes after 10 years, demonstrating the long-term efficacy of this surgical intervention.

The duration of diabetes before surgery was identified as a key predictor of whether patients would maintain remission, suggesting that earlier intervention may lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-year remission rates in insulin-treated type 2 diabetes after biliopancreatic diversion with duodenal switch. Kapeluto, JE., Tchernof, A., Masckauchan, D., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5451258/

Bariatric Surgery versus Intensive Medical Therapy for ... Five-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00432809

Study Details | NCT00432809 | Advanced Medical Therapy ... The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1401329

Bariatric Surgery versus Intensive Medical Therapy for ... 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3372918/

Bariatric Surgery versus Intensive Medical Therapy in ... In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03165812

Study Details | NCT03165812 | A Diabetes Improvement in ... Type 2 Diabetes Mellitus (T2DM) patients in SADJB-SG group achieving glycated hemoglobin (HbA1c) level of less than 7% (with or without diabetes medications) in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10942954/

Therapeutic Inertia in the Management of Type 2 Diabetes Current recommendations advocate for a target HbA1c of < 7% or ≤ 6.5% for most individuals with T2D, with a strong emphasis on goal ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4247540/

Intensive Therapy in Newly Diagnosed Type 2 Diabetes Satisfaction with insulin treatment and willingness to continue insulin injections were both very high (1.4±0.7 and 1.1±0.4, respectively, on a 1–5 scale where ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04128995

NCT04128995 | Surgical or Medical Treatment Metabolic bariatric surgery (MBS) significantly improves multiple outcomes in adults with T2D. Initial small, uncontrolled studies of Roux-en-Y gastric bypass ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1600869

Bariatric Surgery versus Intensive Medical Therapy for ... Five-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy ...