- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07901777
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity (GLP-BARI-VAN)
Comparison of Two-Year Weight-Loss Effectiveness of GLP-1 Receptor Agonists and Laparoscopic Sleeve Gastrectomy in the Treatment of Obesity: An Ambispective Propensity Score-Matched Cohort Study
This observational study will compare weight loss over two years in adults receiving GLP-1 receptor agonist medications with weight loss in adults who previously underwent laparoscopic sleeve gastrectomy, an operation that reduces the size of the stomach.
Adults starting GLP-1 medications as part of their usual care will be followed for 24 months. Their results will be compared with existing medical records of adults who underwent sleeve gastrectomy at the same center. Treatment decisions will be made by patients and their treating clinicians as part of routine care, rather than assigned by the study.
The main outcome is the percentage of starting body weight lost at 24 months. The study will also assess weight changes at earlier visits, medication side effects, treatment continuation and reasons for stopping treatment, and changes in weight-related health conditions. The groups will be matched using baseline characteristics to make the comparison more balanced.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Sebahattin Çelik
- Número de telefone: +90 505 705 79 57
- E-mail: s.celik@yyu.edu.tr
Locais de estudo
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Van, Turquia (Türkiye)
- Recrutamento
- Yüzüncü Yıl University
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Contato:
- Mahir Coşkun
- Número de telefone: +905468843349
- E-mail: s.celik@yyu.edu.tr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Adults aged 18 years or older receiving treatment for obesity or overweight at the Obesity Center of Van Training and Research Hospital, Türkiye. The prospective cohort will include consecutive eligible patients initiating GLP-1 receptor agonist therapy for weight management as part of routine clinical care. The retrospective cohort will include eligible patients who underwent primary laparoscopic sleeve gastrectomy for obesity at the same center between January 1, 2020, and January 1, 2026. Treatment decisions are made independently of study participation. The cohorts will be matched using propensity scores based on pretreatment demographic and clinical characteristics.
Descrição
Inclusion Criteria:
GLP-1 Receptor Agonist Cohort:
- Age 18 years or older at treatment initiation.
- Initiation of a GLP-1 receptor agonist for obesity or overweight as part of routine clinical care.
- Available baseline height and body weight measurements.
- Willingness to attend at least one follow-up assessment.
- Ability to comply with the center's standard follow-up program.
- Provision of written informed consent.
Laparoscopic Sleeve Gastrectomy Cohort:
- Age 18 years or older at surgery.
- Primary laparoscopic sleeve gastrectomy for obesity performed at the study center between January 1, 2020, and January 1, 2026.
- Available preoperative height, body weight, and body mass index measurements.
- Available demographic and baseline clinical data.
- At least one documented postoperative body weight measurement. Availability of a 24-month weight measurement is preferred for the primary comparison.
Exclusion Criteria:
Both Cohorts:
- Bariatric or metabolic surgery before the index treatment.
- Revisional bariatric surgery as the index treatment.
- Active malignancy or a serious systemic disease substantially affecting body weight.
- Pregnancy or breastfeeding at the index treatment.
- Uncontrolled endocrine disease that may cause weight loss.
- Missing baseline height or body weight measurements.
- Recent participation in another intensive weight-loss program before the index treatment.
- Concurrent use of another anti-obesity treatment that could substantially affect study outcomes.
- Inability to reliably verify study data.
GLP-1 Receptor Agonist Cohort:
- Short-term GLP-1 receptor agonist use for an indication other than weight management.
- Medication prescribed but never administered.
Laparoscopic Sleeve Gastrectomy Cohort:
- Sleeve gastrectomy performed concurrently with another bariatric procedure.
- Sleeve gastrectomy performed for an indication other than primary obesity treatment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: OTHER
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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GLP-1 Receptor Agonist Cohort
Adults aged 18 years or older starting a GLP-1 receptor agonist, such as liraglutide or semaglutide, for weight management as part of routine clinical care. Participants will be followed prospectively for 24 months, with assessments at baseline and months 1, 3, 6, 12, and 24. Weight changes, medication use, treatment adherence, adverse events, and treatment discontinuation will be recorded. Medication selection and dosing will be determined by the treating clinician independently of study participation. |
GLP-1 receptor agonists, such as liraglutide or semaglutide, prescribed for weight management as part of routine clinical care. Medication selection, dose escalation, dose adjustment, and treatment discontinuation are determined by the treating clinician and are not assigned by the study protocol. Medication use, weight changes, treatment adherence, and adverse events will be recorded during 24 months of prospective follow-up.
Outros nomes:
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Laparoscopic Sleeve Gastrectomy Cohort
Adults who underwent primary laparoscopic sleeve gastrectomy for obesity at the same center between January 1, 2020, and January 1, 2026, and were aged 18 years or older at surgery. Existing medical records will be reviewed retrospectively for baseline characteristics, postoperative weight measurements through 24 months, and surgical complications. This cohort will be matched with the GLP-1 receptor agonist cohort using propensity scores based on pretreatment characteristics. Surgery was performed as part of routine clinical care independently of this study. |
Primary laparoscopic sleeve gastrectomy performed for obesity as part of routine clinical care between January 1, 2020, and January 1, 2026. The procedure involves removing a large portion of the stomach to create a narrow, sleeve-shaped stomach. Existing medical records will be reviewed retrospectively to assess weight changes and surgical complications through 24 months after surgery. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Total Body Weight change at 24 Months
Prazo: 24 months after GLP-1 receptor agonist treatment initiation or sleeve gastrectomy.
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Percentage of total body weight loss (%TWL), calculated as [(baseline body weight - body weight at 24 months) / baseline body weight] × 100. Baseline is the date of GLP-1 receptor agonist treatment initiation or sleeve gastrectomy. The outcome will be compared between the propensity score-matched treatment cohorts. |
24 months after GLP-1 receptor agonist treatment initiation or sleeve gastrectomy.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Total Body Weight change at Earlier Follow-Up Visits
Prazo: At 1, 3, 6, and 12 months after treatment initiation.
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Percentage of total body weight loss (%TWL), calculated as [(baseline body weight - follow-up body weight) / baseline body weight] × 100, compared between the treatment cohorts. |
At 1, 3, 6, and 12 months after treatment initiation.
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Change in Body Weight
Prazo: Baseline to months 1, 3, 6, 12, and 24.
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Change in body weight from baseline, measured in kilograms, compared between the treatment cohorts. |
Baseline to months 1, 3, 6, 12, and 24.
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Change in Body Mass Index
Prazo: Baseline to months 1, 3, 6, 12, and 24.
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Change in body mass index (BMI) from baseline, calculated as body weight in kilograms divided by height in meters squared, compared between the treatment cohorts. |
Baseline to months 1, 3, 6, 12, and 24.
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Percentage of Participants Achieving at Least 5% Total Body Weight Loss
Prazo: At months 1, 3, 6, 12, and 24.
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Percentage of participants losing at least 5% of their baseline body weight, compared between the treatment cohorts. |
At months 1, 3, 6, 12, and 24.
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Percentage of Participants Achieving at Least 10% Total Body Weight Loss
Prazo: At months 1, 3, 6, 12, and 24.
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Percentage of participants losing at least 10% of their baseline body weight, compared between the treatment cohorts. |
At months 1, 3, 6, 12, and 24.
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Percentage of Participants Achieving at Least 15% Total Body Weight Loss
Prazo: At months 1, 3, 6, 12, and 24.
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Percentage of participants losing at least 15% of their baseline body weight, compared between the treatment cohorts. |
At months 1, 3, 6, 12, and 24.
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Percentage of Participants Achieving at Least 20% Total Body Weight Loss
Prazo: At months 1, 3, 6, 12, and 24.
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Percentage of participants losing at least 20% of their baseline body weight, compared between the treatment cohorts. |
At months 1, 3, 6, 12, and 24.
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Percentage of Participants Achieving at Least 25% Total Body Weight Loss
Prazo: At months 1, 3, 6, 12, and 24.
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Percentage of participants losing at least 25% of their baseline body weight, compared between the treatment cohorts. |
At months 1, 3, 6, 12, and 24.
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Percentage of Participants Experiencing Any Adverse Event During GLP-1 Therapy
Prazo: From the first medication dose through 24 months.
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Percentage of participants in the GLP-1 receptor agonist cohort experiencing at least one adverse event. Event type, onset, severity, and suspected relationship to medication will be recorded. |
From the first medication dose through 24 months.
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Percentage of Participants Experiencing Gastrointestinal Adverse Events During GLP-1 Therapy
Prazo: From the first medication dose through 24 months.
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Percentage of participants in the GLP-1 receptor agonist cohort experiencing gastrointestinal adverse events, including nausea, vomiting, diarrhea, constipation, abdominal pain, or reflux/dyspepsia. |
From the first medication dose through 24 months.
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Percentage of Participants Experiencing Serious Adverse Events During GLP-1 Therapy
Prazo: From the first medication dose through 24 months.
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Percentage of participants in the GLP-1 receptor agonist cohort experiencing an adverse event resulting in death, a life-threatening condition, inpatient hospitalization or prolonged hospitalization, persistent or significant disability, a congenital anomaly, or another medically important event. |
From the first medication dose through 24 months.
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Percentage of Participants Requiring GLP-1 Dose Reduction Due to Adverse Events
Prazo: From treatment initiation through 24 months.
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Percentage of participants in the GLP-1 receptor agonist cohort whose medication dose is reduced because of an adverse event. |
From treatment initiation through 24 months.
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Percentage of Participants Permanently Discontinuing GLP-1 Therapy Due to Adverse Events
Prazo: From treatment initiation through 24 months.
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Percentage of participants in the GLP-1 receptor agonist cohort who permanently discontinue medication because of an adverse event. |
From treatment initiation through 24 months.
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Percentage of Participants Permanently Discontinuing GLP-1 Therapy for Any Reason
Prazo: From treatment initiation through 24 months.
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Percentage of participants in the GLP-1 receptor agonist cohort who permanently discontinue medication for any reason. Reasons for discontinuation will be recorded. |
From treatment initiation through 24 months.
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Duration of GLP-1 Treatment Persistence
Prazo: From treatment initiation through 24 months.
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Time in months from GLP-1 receptor agonist treatment initiation to permanent discontinuation. Participants without permanent discontinuation will be censored at their last known follow-up or the end of the 24-month observation period. |
From treatment initiation through 24 months.
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Improvement or Remission of Obesity-Related Comorbidities
Prazo: At months 3, 6, 12, and 24.
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Percentage of participants with improvement or remission of baseline obesity-related comorbidities, including type 2 diabetes, hypertension, and dyslipidemia, assessed separately for each condition using available clinical records, laboratory results, and medication changes. |
At months 3, 6, 12, and 24.
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Percentage of Participants With Emergency Department Visits
Prazo: From treatment initiation through 24 months.
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Percentage of participants with at least one emergency department visit during follow-up, assessed in each treatment cohort using available records. |
From treatment initiation through 24 months.
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Percentage of Participants With Hospital Admissions
Prazo: From treatment initiation through 24 months.
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Percentage of participants with at least one hospital admission during follow-up, excluding the index admission for sleeve gastrectomy, assessed in each treatment cohort using available records. |
From treatment initiation through 24 months.
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Percentage of Participants With Early Surgical Complications
Prazo: Within 30 days after sleeve gastrectomy.
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Percentage of participants in the sleeve gastrectomy cohort experiencing a complication within 30 days after surgery, including bleeding, staple-line leak, or complications requiring reoperation. Complications will be graded using the Clavien-Dindo classification when sufficient information is available. |
Within 30 days after sleeve gastrectomy.
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Percentage of Participants With Late Surgical Complications
Prazo: From postoperative day 31 through 24 months.
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Percentage of participants in the sleeve gastrectomy cohort experiencing complications more than 30 days after surgery, including stenosis, gastroesophageal reflux, nutritional deficiencies, or complications requiring revision surgery, as documented in available records. |
From postoperative day 31 through 24 months.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
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Conclusão Primária (Estimado)
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- GLP-BARI-VAN
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