- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07829016
GLP-1 Impacts on Weight Management (GLOW)
GLP-1 Longitudinal Outcomes in Weight Management
The goal of this observational study is to learn about the long-term effects of GLP-1RAs (Ozempic, Wegovy, Rybelsus, Mounjaro, or Zepbound) in adolescents and young adults aged 12-21 who will start taking this drug for weight management. The main question it aims to answer is:
How does starting GLP-1RAs impact eating behaviors and mental health symptoms?
Participants starting to take GLP-1RAs as part of their medical care for weight management will answer online survey questions about their experience taking the drug for 1 year.
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Franziska Plessow, PhD
- Telefonní číslo: 4153532747
- E-mail: Franziska.Plessow@ucsf.edu
Studijní místa
-
-
California
-
San Francisco, California, Spojené státy, 94158
- University of California San Francisco, Mission Bay Campus
-
Kontakt:
- Marissa Raymond-Flesch, MD/MPH
- Telefonní číslo: 415-353-2747
- E-mail: GLOWStudy@ucsf.edu
-
Vrchní vyšetřovatel:
- Marissa Raymond-Flesch, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Able to understand and provide informed consent or, for minor participants, able to provide assent with parent/guardian informed consent
- Age 12 and 21 years at the time of consent
- Able to read and write in English; for minor participants, at least one parent/guardian must be able to read and write in English or Spanish
- Willing and able to complete all required in-person and remote study visits and procedures
- Current binge-eating symptomatology
- Initiating first-time GLP-1RA therapy or related incretin-based therapy for weight management (Ozempic, Rybelsus, Wegovy)
- Meets current FDA medication eligibility criteria for prescribed GLP-1RA treatment for weight management: BMI ≥95th percentile OR ≥85th percentile with ≥1 weight-related comorbidity for those <18 years old and a BMI>30 or BMI>26 with ≥1 weight-related comorbidity for those 18 years old and older
- Has reliable access to prescribed GLP1-RA medication through insurance coverage, self-payment, or discount pharmacy plans and is willing to take it as prescribed for the duration of study participation
- On a stable regimen of permitted concomitant medications for at least 1 month prior to GLP-1RA initiation. Participants recently taking prohibited medications may be eligible after an adequate wash-out period as applicable (minimum of 5 half-lives).
- Receiving care in a clinic affiliated with the research study
Exclusion Criteria:
- Current use of Lisdexamfetamine (Vyvanse) or insufficient washout from such medication prior to GLP-1RA initiation
- Anticipated medication changes or planned surgical procedures during the study period that, in the investigator's judgment, could affect study participation of interpretation of outcomes
- Known genetic metabolic or endocrine syndromes associated with obesity, including Prader Willi Syndrome and familial hypercholesterolemia
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Type 1 or type 2 diabetes
- History of pancreatitis
- Documented uncontrolled thyroid disease
- History of bariatric surgery
- Current pregnancy or known plans to become pregnant within the next 6 months
- Suicidality or any suicide attempts within the past 3 months
- Current severe depressive symptoms at screening
- Any medical, psychiatric, behavioral, or other condition, disorder, or circumstance not otherwise specified in the exclusion criteria that, in the investigator's judgment, may compromise participant safety, study participation, or adherence to the protocol
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
Adolescents and Young Adults (12-21)
Adolescents and Young Adults who plan to start GLP-1RA treatment for weight management.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in the frequency of Objective Binge Episodes
Časové okno: 6 months
|
Change in the frequency of OBEs over the past 28 days from baseline to 6 months following GLP-1RA initiation, as measured by the Eating Disorder Examination (EDE) Binge-Eating Module
|
6 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Frequency of LOC Episodes
Časové okno: Baseline to 6 months
|
Change in the frequency of LOC episodes over the past 28 days from baseline to 6 months following GLP-1RA initiation, as measured by a single-item question (key secondary endpoint)
|
Baseline to 6 months
|
|
Change in Frequency of OBEs
Časové okno: From baseline to 4 months
|
Change in the frequency of OBEs over the past 28 days from baseline to 4 months following GLP-1RA initiation, as measured by the EDE Binge-Eating Module
|
From baseline to 4 months
|
|
Change in Frequency of LOC Episodes
Časové okno: Baseline to 4 months
|
Change in the frequency of LOC episodes over the past 28 days from baseline to 4 months following GLP-1RA initiation, as measured by a single-item question
|
Baseline to 4 months
|
|
Change in Disordered Eating Symptom Severity
Časové okno: Baseline to 4-6 months
|
Change in overall disordered eating symptom severity over the past 28 days from baseline to 4 and 6 months following GLP-1RA initiation, as measured by the Eating Disorder Examination-Questionnaire (EDE-Q) Global score
|
Baseline to 4-6 months
|
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Change in Body Esteem
Časové okno: Baseline to Month 4 and 6
|
Change in body esteem from baseline to 4 and 6 months following GLP-1RA initiation, as measured by the Body Esteem Scale for Adolescents and Adults (BESAA)
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Baseline to Month 4 and 6
|
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Change in Food Noise
Časové okno: Baseline to 4 and 6 months
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Change in food noise from baseline to 4 and 6 months following GLP-1RA initiation, as measured by the Food Noise Questionnaire (FNQ) Total score
|
Baseline to 4 and 6 months
|
|
Change in Frequency on Purging Behaviors
Časové okno: Baseline to 4 and 6 Months
|
Change in the frequency of purging behaviors over the past 28 days from baseline to 4 and 6 months following GLP-1RA initiation, as measured by the EDE-Q
|
Baseline to 4 and 6 Months
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Marissa Raymond-Flesch, MD, MPH, University of California, San Francisco
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00000173
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