← Back to Search

Advanced Medical Therapy

Bariatric Surgery vs. Medication for Type 2 Diabetes (ST2OMP Trial)

Phase 4
Recruiting
Led By Kristen J Nadeau, MD MS
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 2 diabetes by the American Diabetes Association criteria
Clinical indication to receive bariatric surgery
Must not have
Prior bariatric surgery
Chronic kidney or liver disease (except NAFLD or DKD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 2 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the long-term effects of weight-loss surgery to diabetes medication.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from bariatric surgery can include nutritional deficiencies, digestive issues like nausea and vomiting, gallstones, and surgical complications. Advanced medical therapy may cause low blood sugar events among other medication-specific side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Type 2 diabetes.
Select...
I am medically recommended to undergo weight loss surgery.
Select...
I am between 13 and 19 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had weight loss surgery in the past.
Select...
I have chronic kidney or liver disease, but not due to fatty liver or diabetes.
Select...
I am not taking any medications that are harmful to the pancreas.
Select...
I have type 1 diabetes, MODY, or diabetes caused by another condition.
Select...
I have had cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Alpha cell function
Beta Cell Function
Diabetic Nephropathy
+6 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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 Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,503 Total Patients Enrolled
Children's Hospital ColoradoOTHER
120 Previous Clinical Trials
5,133,091 Total Patients Enrolled
Kristen J Nadeau, MD MSPrincipal InvestigatorChildren's Hospital Colorado
Michael A Helmrath, MD MSPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
Thomas H Inge, MD PhDPrincipal InvestigatorLurie Children's Hospital
Amy S Shah, MD MSPrincipal InvestigatorCincinnati Childrens Hospital Medical Center

Media Library

Advanced Medical Therapy (Advanced Medical Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04128995 — Phase 4
Type 2 Diabetes Research Study Groups: Bariatric Surgery in Youth with Obesity, Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes, Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes
Type 2 Diabetes Clinical Trial 2023: Advanced Medical Therapy Highlights & Side Effects. Trial Name: NCT04128995 — Phase 4
Advanced Medical Therapy (Advanced Medical Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04128995 — Phase 4
~17 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top