Surgical or Medical Treatment for Pediatric Type 2 Diabetes
Comparing Surgery vs. Medicine for Teen Type 2 Diabetes
Plain English Summary
Surgical or Medical Treatment is a Phase 4 clinical trial sponsored by Children's Hospital Medical Center, Cincinnati studying Diabetes Mellitus, Type 2, Pediatric Obesity, Bariatric Surgery Candidate. This study compares if weight-loss surgery (bariatric surgery) is better than intensive medical treatment for controlling type 2 diabetes in teenagers. It is for young people aged 13-19 with type 2 diabetes, who meet specific health criteria. Participation involves either undergoing bariatric surgery or intensive medical therapy, with regular follow-up visits. Alternatives include standard medical management of type 2 diabetes, which may involve lifestyle changes and medication. The trial aims to enroll 88 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Teens aged 13 to 19.9 years old with type 2 diabetes. Must not have type 1 diabetes, MODY, or secondary diabetes. Cannot have used steroid pills in the last 60 days or be using certain other medications. Cannot have serious kidney or liver disease (unless it's NAFLD or DKD), be pregnant, or have had bariatric surgery before. This trial is studying Diabetes Mellitus, Type 2, Pediatric Obesity, Bariatric Surgery Candidate, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well blood sugar levels are controlled one year after treatment, indicating the effectiveness of surgery versus medical therapy. The specific primary outcome measures are: Glycemic Control (At one year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial addresses a critical need for effective, long-term solutions for type 2 diabetes in adolescents, a growing public health concern. This research targets Diabetes Mellitus, Type 2, Pediatric Obesity, Bariatric Surgery Candidate, where improved treatment options are needed.
Investor Insight
This trial could signal a shift in treatment paradigms for pediatric type 2 diabetes, potentially impacting the market for bariatric procedures and diabetes medications in this age group. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of both bariatric surgery and intensive medical therapy. Understand the commitment involved in regular clinic visits, tests, and potential lifestyle changes. Discuss how participation might affect your daily routine, school, and social activities. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 88 participants
Interventions
- PROCEDURE: Advanced Medical Therapy and Bariatric Surgery — Vertical Sleeve Gastrectomy and Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes
- DRUG: Advanced Medical Therapy — Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes
- PROCEDURE: Bariatric Surgery — Vertical Sleeve Gastrectomy for youth without type 2 diabetes
Primary Outcomes
- Glycemic Control (At one year)
Secondary Outcomes
- Glycemic Control (At two years)
- Glycemic Variability (At one year)
- Beta Cell Function (at 1 and 2 years)
- Alpha cell function (at 1 and 2 years)
- Incretin Response (at 1 and 2 years)
Full Eligibility Criteria
Inclusion Criteria for the medical or surgical type 2 diabetes groups * Age 13-19.9 years of age at time of signing the consent * Type 2 diabetes by the American Diabetes Association criteria * Negative diabetes-associated antibodies Exclusion Criteria for the medical or surgical type 2 diabetes groups Known type 1 diabetes, maturity onset diabetes of the young (MODY), or secondary diabetes * Any chronic oral steroids use within 60 days of enrollment * Current pancreatotoxic drugs * Chronic kidney or liver disease (except NAFLD or DKD) * Pregnancy, breast-feeding or intension of becoming pregnant * Prior bariatric surgery * History of malignancy * Current participation in another clinical trial that may affect study outcomes * Other conditions, that in the determination of the study investigator, may interfere with study participation * Inclusion Criteria for the Obese control group * Age 13-19.9 years of age at time of signing the consent * Clinical indication to receive bariatric surgery Exclusion Criteria for the obese control group * Known diabetes * Any chronic oral steroids use within 60 days of enrollment * Current pancreatotoxic drugs * Chronic kidney or liver disease (except NAFLD or DKD) * Pregnancy, breast-feeding or intension of becoming pregnant * Prior bariatric surgery * History of malignancy * Current participation in another clinical trial that may affect study outcomes * Other conditions, that in the determination of the study investigator, may interfere with study participation
Trial Locations
- Children's Hospital Colorado, Aurora, Colorado, United States
- Lurie Children's Hospital, Chicago, Illinois, United States
- Cincinnati Childrens, Cincinnati, Ohio, United States
Frequently Asked Questions
What is clinical trial NCT04128995?
NCT04128995 is a Phase 4 INTERVENTIONAL study titled "Surgical or Medical Treatment." It is currently active, not recruiting and is sponsored by Children's Hospital Medical Center, Cincinnati. The trial targets enrollment of 88 participants.
What conditions does NCT04128995 study?
This trial investigates treatments for Diabetes Mellitus, Type 2, Pediatric Obesity, Bariatric Surgery Candidate. The primary condition under study is Diabetes Mellitus, Type 2.
What treatments are being tested in NCT04128995?
The interventions being studied include: Advanced Medical Therapy and Bariatric Surgery (PROCEDURE), Advanced Medical Therapy (DRUG), Bariatric Surgery (PROCEDURE). Vertical Sleeve Gastrectomy and Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes
What does Phase 4 mean for NCT04128995?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT04128995?
This trial is currently "Active, Not Recruiting." It started on 2019-12-15. The estimated completion date is 2026-12.
Who is sponsoring NCT04128995?
NCT04128995 is sponsored by Children's Hospital Medical Center, Cincinnati. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04128995?
The trial aims to enroll 88 participants. The trial status is active, not recruiting.
How is NCT04128995 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT04128995?
The primary outcome measures are: Glycemic Control (At one year). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04128995 being conducted?
This trial is being conducted at 3 sites, including Aurora, Colorado; Chicago, Illinois; Cincinnati, Ohio (United States).
Where can I find official information about NCT04128995?
The official record for NCT04128995 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04128995. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04128995 testing in simple terms?
This study compares if weight-loss surgery (bariatric surgery) is better than intensive medical treatment for controlling type 2 diabetes in teenagers. It is for young people aged 13-19 with type 2 diabetes, who meet specific health criteria.
Why is this trial significant?
This trial addresses a critical need for effective, long-term solutions for type 2 diabetes in adolescents, a growing public health concern.
What are the potential risks of participating in NCT04128995?
Risks associated with bariatric surgery include infection, bleeding, and complications from anesthesia. Potential side effects of intensive medical therapy can include digestive issues, and risks associated with specific medications. There's a possibility that neither treatment may achieve the desired blood sugar control. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04128995?
Ask your doctor about the potential benefits and risks of both bariatric surgery and intensive medical therapy. Understand the commitment involved in regular clinic visits, tests, and potential lifestyle changes. Discuss how participation might affect your daily routine, school, and social activities. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04128995 signal from an investment perspective?
This trial could signal a shift in treatment paradigms for pediatric type 2 diabetes, potentially impacting the market for bariatric procedures and diabetes medications in this age group. This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves either undergoing bariatric surgery or intensive medical therapy, with regular follow-up visits. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.