NCT07859163Toborzás még nem indult4. fázis
Semaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain
Semaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain: a Randomized, Double-blind, Placebo-controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 5.
Rövid összefoglaló (regiszter, angolul)
Recurrent weight gain affects 15% to 40% of patients after metabolic and bariatric surgery (MBS). SG is the most performed operation worldwide, and long-term regain after SG is well documented. A 2026 international Delphi consensus has now standardized the definition. This trial uses that definition. So does our companion trial, RESURGE. We have two real treatments. Both work. Neither is enough. Conversion of SG to RYGB gives around 20% additional total weight loss at 12 months across all indications, and less when the indication is poor weight response rather than reflux. Drug therapy also works after MBS. Liraglutide beat placebo by about 8 percentage points in the BARI-OPTIMISE randomized trial. Semaglutide gives around 11% total weight loss and tirzepatide around 14% in pooled retrospective data, including specifically after SG. Most patients do not return to their nadir weight with either option alone. The field is already comparing the two strategies, but only retrospectively. Two 2025 multicenter cohorts compared conversion against GLP-1 therapy after SG. These studies cannot control diet, exercise, supplementation, co-medication, or adherence. They cannot settle the question. The societies agree on the pathway but admit the evidence is weak. The 2024 IFSO position statement and the 2026 ASMBS statement say the same thing: work up the anatomy first; operate when there is a structural problem; consider medical therapy when there is not; and consider combining drug therapy with revision. The 2024 IFSO international consensus goes further: with 92% agreement, it states that medications should generally be considered before revisional surgery for recurrent weight gain. Every one of those recommendations rests on consensus and retrospective data. None rests on a randomized trial. This protocol is that trial.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2026. szept. 29.
- Kezdés
- 2026. okt.
- Elsődleges befejezés
- 2029. ápr.
- Fő szponzor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Betegségek
- Elhízás
- NCT-szám
- NCT07859163
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 4. fázis
- Tervezett résztvevők: 100
- 2026. okt. és az elsődleges befejezés (2029. ápr.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- Anatomy. These patients need surgery regardless of drug response, so randomizing them is not ethical. They are operated outside the trial. This is the operational form of the rule: anatomical cause, direct surgery; no anatomical cause, eligible for the trial.
- Staple-line leak or gastric fistula.
- Sleeve stenosis or axial twist.
- Hiatal hernia larger than 3 cm.
- Los Angeles grade C or D esophagitis, or Barrett's esophagus.
Laborértékek
- Drug and general safety
- GLP-1 receptor agonist use within the last 6 months, or previous intolerance.
- History of pancreatitis.
- Personal or family history of medullary thyroid carcinoma or MEN2.
- Type 1 diabetes; eGFR below 30 mL/min/1.73 m²; active malignancy.
- Pregnancy, breastfeeding, or pregnancy plans during the study. Women of childbearing potential must use reliable contraception. Per current labeling and the 2026 Standards, obesity pharmacotherapy is stopped at least 2 months before any planned conception.
- Uncontrolled psychiatric disease or active substance use disorder.
- Current smoking, unless cessation is completed before surgery per unit policy.
- Any other anti-obesity medication within the last 3 months.
Kiket keres a vizsgálat
- SG at least 2 years before screening.
- Recurrent weight gain meeting the international Delphi consensus definition. Operational entry threshold for this trial: regain of at least 20% of the maximal weight lost, measured from nadir.
- BMI of 35 kg/m² or more, or 30 kg/m² or more with at least one obesity-associated disease, and accepted for conversion to RYGB by the multidisciplinary team.
- Upper endoscopy and contrast imaging completed.
- Able to give written informed consent.
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The surgical department of Medical Research Institute Hospital, Alexandria University | Alexandria | Egyiptom | Ismeretlen állapot |
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