GLP-1 Impacts on Weight Management (GLOW)
2026年9月14日 更新者：University of California, San Francisco
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.
調査の概要
詳細な説明
This prospective single-arm observational study will enroll 100 adolescents and young adults 12 to 21 years of age who are initiating a prescribed glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy or related incretin-based therapy for weight management.
The study will assess longitudinal changes in eating behaviors and related clinical features from pre-treatment baseline through 6 months of GLP-1RA treatment, spanning treatment initiation, titration, and maintenance.
Exploratory cognitive assessments and biomarker collection will examine behavioral and biological correlates of change.
After 6 months, participants will be in follow-up and attend a final study visit at their 12-month mark.
研究の種類
観察的
入学 (推定)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Franziska Plessow, PhD
- 電話番号：4153532747
- メール：Franziska.Plessow@ucsf.edu
研究場所
-
-
California
-
San Francisco、California、アメリカ、94158
- University of California San Francisco, Mission Bay Campus
-
コンタクト：
- Marissa Raymond-Flesch, MD/MPH
- 電話番号：415-353-2747
- メール：GLOWStudy@ucsf.edu
-
主任研究者：
- Marissa Raymond-Flesch, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Participants will be 12-21 years olds who plan to begin GLP-1RA treatment for weight management.
Participants will be current patients receiving care from UCSF affiliated clinics.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Adolescents and Young Adults (12-21)
Adolescents and Young Adults who plan to start GLP-1RA treatment for weight management.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in the frequency of Objective Binge Episodes
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Frequency of LOC Episodes
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
|
Change in Body Esteem
時間枠：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)
|
Baseline to Month 4 and 6
|
|
Change in Food Noise
時間枠：Baseline to 4 and 6 months
|
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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Marissa Raymond-Flesch, MD, MPH、University of California, San Francisco
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2029年9月1日
研究の完了 (推定)
2029年9月1日
試験登録日
最初に提出
2026年9月14日
QC基準を満たした最初の提出物
2026年9月14日
最初の投稿 (実際)
2026年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18日
QC基準を満たした最後の更新が送信されました
2026年9月14日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。