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Bariatric Surgery vs. Medication for Type 2 Diabetes (ST2OMP Trial)
ST2OMP Trial Summary
This trial will compare the long-term effects of weight-loss surgery to diabetes medication.
ST2OMP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowST2OMP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ST2OMP Trial Design
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Who is running the clinical trial?
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- I have had weight loss surgery in the past.I have chronic kidney or liver disease, but not due to fatty liver or diabetes.I have been diagnosed with Type 2 diabetes.I am medically recommended to undergo weight loss surgery.I am not taking any medications that are harmful to the pancreas.I have type 1 diabetes, MODY, or diabetes caused by another condition.I have not taken oral steroids regularly in the last 60 days.I have had cancer before.You do not have certain antibodies associated with diabetes.I am between 13 and 19 years old.
- Group 1: Bariatric Surgery in Youth with Obesity
- Group 2: Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes
- Group 3: Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there availability for participants in this trial?
"Affirmative. The information hosted by clinicaltrials.gov indicates that this examination, which was initially published on December 15th 2019 is currently seeking participants. Around 100 individuals need to be signed up from 2 different medical locations."
To what capacity is the study population participating in this trial?
"Affirmative. According to the information posted on clinicaltrials.gov, this trial is still open for recruitment and has been since December 15th 2019; it was last edited in November 10th 2022. This investigation requires 100 participants from 2 different sites."
What qualifications are needed to enroll in this research trial?
"This study is searching for 100 young individuals, aged between 13 and 19.9 years old, who are suffering from obesity related Type 2 diabetes. For entry into the trial, these participants must meet a number of criteria which include: an American Diabetes Association diagnosis of diabetes; negative antibodies associated with this disorder; inclusionary requirements for medical or surgical type two diabetes therapies; a BMI greater than 30 and be willing to take oral medications as prescribed by their physician."
Is the participant pool for this trial comprised of individuals over 65?
"The criteria for participation in this clinical trial necessitates that candidates are between the ages of 13 and 19. The study has recruited 186 minors, as well as 750 seniors above 65 years old."
To what extent does bariatric surgery pose a hazard for minors struggling with obesity?
"There is considerable evidence that bariatric surgery in youth with obesity is safe, thus resulting in a score of 3."
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