Trial · NCT07901777
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Total Body Weight change at 24 Months | 24 months after GLP-1 receptor agonist treatment initiation or sleeve gastrectomy. | 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. |
| Secondary | Percentage of Total Body Weight change at Earlier Follow-Up Visits | At 1, 3, 6, and 12 months after treatment initiation. | 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. |
| Secondary | Change in Body Weight | Baseline to months 1, 3, 6, 12, and 24. | Change in body weight from baseline, measured in kilograms, compared between the treatment cohorts. |
| Secondary | Change in Body Mass Index | Baseline to months 1, 3, 6, 12, and 24. | 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. |
| Secondary | Percentage of Participants Achieving at Least 5% Total Body Weight Loss | At months 1, 3, 6, 12, and 24. | Percentage of participants losing at least 5% of their baseline body weight, compared between the treatment cohorts. |
| Secondary | Percentage of Participants Achieving at Least 10% Total Body Weight Loss | At months 1, 3, 6, 12, and 24. | Percentage of participants losing at least 10% of their baseline body weight, compared between the treatment cohorts. |
| Secondary | Percentage of Participants Achieving at Least 15% Total Body Weight Loss | At months 1, 3, 6, 12, and 24. | Percentage of participants losing at least 15% of their baseline body weight, compared between the treatment cohorts. |
| Secondary | Percentage of Participants Achieving at Least 20% Total Body Weight Loss | At months 1, 3, 6, 12, and 24. | Percentage of participants losing at least 20% of their baseline body weight, compared between the treatment cohorts. |
| Secondary | Percentage of Participants Achieving at Least 25% Total Body Weight Loss | At months 1, 3, 6, 12, and 24. | Percentage of participants losing at least 25% of their baseline body weight, compared between the treatment cohorts. |
| Secondary | Percentage of Participants Experiencing Any Adverse Event During GLP-1 Therapy | From the first medication dose through 24 months. | 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. |
| Secondary | Percentage of Participants Experiencing Gastrointestinal Adverse Events During GLP-1 Therapy | From the first medication dose through 24 months. | Percentage of participants in the GLP-1 receptor agonist cohort experiencing gastrointestinal adverse events, including nausea, vomiting, diarrhea, constipation, abdominal pain, or reflux/dyspepsia. |
| Secondary | Percentage of Participants Experiencing Serious Adverse Events During GLP-1 Therapy | From the first medication dose through 24 months. | 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. |
| Secondary | Percentage of Participants Requiring GLP-1 Dose Reduction Due to Adverse Events | From treatment initiation through 24 months. | Percentage of participants in the GLP-1 receptor agonist cohort whose medication dose is reduced because of an adverse event. |
| Secondary | Percentage of Participants Permanently Discontinuing GLP-1 Therapy Due to Adverse Events | From treatment initiation through 24 months. | Percentage of participants in the GLP-1 receptor agonist cohort who permanently discontinue medication because of an adverse event. |
| Secondary | Percentage of Participants Permanently Discontinuing GLP-1 Therapy for Any Reason | From treatment initiation through 24 months. | Percentage of participants in the GLP-1 receptor agonist cohort who permanently discontinue medication for any reason. Reasons for discontinuation will be recorded. |
| Secondary | Duration of GLP-1 Treatment Persistence | From treatment initiation through 24 months. | 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. |
| Secondary | Improvement or Remission of Obesity-Related Comorbidities | At months 3, 6, 12, and 24. | 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. |
| Secondary | Percentage of Participants With Emergency Department Visits | From treatment initiation through 24 months. | Percentage of participants with at least one emergency department visit during follow-up, assessed in each treatment cohort using available records. |
| Secondary | Percentage of Participants With Hospital Admissions | From treatment initiation through 24 months. | 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. |
| Secondary | Percentage of Participants With Early Surgical Complications | Within 30 days after sleeve gastrectomy. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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