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Semaglutide vs Lifestyle Changes for PCOS (TEAL Trial)
TEAL Trial Summary
This trial will test whether a GLP-1 agonist or a dietary intervention can help girls with obesity and PCOS lower hepatic fat and improve insulin sensitivity.
TEAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTEAL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEAL Trial Design
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Who is running the clinical trial?
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- You have had a bad reaction to semaglutide in the past.I have a severe stomach or intestine condition.I have not been hospitalized for a severe illness in the last 60 days.My high androgen levels or missed periods are not due to other health issues like tumors or thyroid disease.My BMI is in the top 10% for my age and gender.I have had gallstones in the past.I have had pancreatitis before.I have liver disease, but it's not NAFLD, or my liver enzymes are high.I am currently experiencing symptoms or receiving treatment for an eating disorder.My last A1C level was above 6.4%, indicating diabetes.I have PCOS, diagnosed with irregular periods and high testosterone.I haven't used metformin, certain steroids, psychiatric drugs, immunosuppressants, HIV drugs, hormonal birth control (past 6 months), weight loss drugs, stimulants, or GLP-1 agonists recently.I have a thyroid condition that hasn't been treated.I or someone in my family has medullary thyroid cancer or MEN 2.I have kidney disease or my kidney function test is low.I am not using hormonal birth control and will use non-hormonal methods or abstain during the study.I am taking medication for high blood pressure.You have metal devices in your body that cannot be safely used during an MRI scan.My BMI is below the 90th percentile for my age and sex, and my weight is either over 325 lbs or under 84 lbs.You do not engage in physical activity for at least 2 hours per week at a moderate intensity (such as jogging or swimming).
- Group 1: GLP-1 Intervention
- Group 2: Diet Intervention
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the average patient's reason for taking Semaglutide 3mg and 7mg [Rybelsus]?
"Semaglutide 3mg and 7mg [Rybelsus] can help patients manage their chronic weight, by reducing the number of calories they consume and increasing exercise."
If a patient is 75 years or younger, can he/she participate in this research project?
"Out of the 439 total clinical trials, this one specifically aims to enroll patients that are aged 12-21. For reference, there are 161 other studies for children under 18 and 117 for adults over 65."
Are there precedents for dosages of Semaglutide 3mg and 7mg [Rybelsus] in clinical trials?
"Currently, there are 27 Phase 3 clinical trials underway for Semaglutide 3mg and 7mg [Rybelsus]. 59 active research studies are being conducted globally, with the majority of them based in Loma Linda, California. 3899 different locations are running these clinical trials."
Does this research have any precedents?
"Semaglutide 3mg and 7mg [Rybelsus] has undergone many clinical trials since its initial one in 2018. The most recent ones are still active, taking place across 55 countries and 766 cities. Novo Nordisk A/S sponsored the first study which 1387 patients completed Phase 4 of. As of now, 126 studies have concluded."
How many patients are being treated with this new medication?
"Yes, up-to-date information on clinicaltrials.gov indicates that this study is still looking for volunteers. The trial was originally posted on May 3rd, 2019 and was last edited on August 10th, 2020. Currently, the study is only recruiting at 1 site but needs 50 total participants."
Which patients would be the best candidates for this clinical trial?
"This trial is admitting 50 patients with obesity aged 12 and 21. Most notable, applicants are required to meet the following criteria: Participants cannot be on hormonal contraception, so participants should remain abstinent or use reliable non-hormonal contraception (e.g. copper IUD) for the entire study period. For participants who receive semaglutide, they should avoid pregnancy for at least 2 months after stopping medication to avoid fetal exposure to the medication., BMI equal or greater than the 90th percentile for age and gender, Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.."
Are there any available positions for patients in this trial?
"That is correct, the public posting on clinicaltrials.gov says that this research is currently looking for volunteers. The trial was established on May 3rd, 2019 and updated as recently as August 10th, 2020. They are hoping to find 50 individuals across 1 site."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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