Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates

Last updated: February 26, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Kidney Transplantation

Diabetes Prevention

Treatment

Endoscopic Sleeve Gastroplasty (ESG)

Clinical Study ID

NCT05917795
5764
  • Ages 18-70
  • All Genders

Study Summary

The aim of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects (≥35 kg/m2) with end stage renal disease who need of kidney transplantation to reduce their BMI below 35 in order to be inserted in the waiting list BMI. The main question[s] it aims to answer are:

Is the procedure effective in reducing BMI to the target level in 12 months? Which is the effect on weight loss, quality of life and obesity-related comorbidities? Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (i.e., age between 18 and 70 years).
  • BMI ≥ 35 kg/m²;
  • Patients with chronic kidney disease (CKD) G4-G5 (glomerular filtration rate [GFR] <30ml/min/1.73 m2) who are expected to reach end-stage kidney disease (ESKD) at least 6 to 12 months before anticipated dialysis initiation (pre-emptive transplantcandidates) or patients already on haemodialysis when medically stable and kidneyfailure deemed irreversible;
  • Patients not listed because of a high BMI according to the policy of the transplantCentre (cut-off 35 kg/m2);
  • Signed informed consent.

Exclusion

Exclusion Criteria:

  • Patients on peritoneal dialysis
  • Upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months;
  • Ongoing or active malignancy during the last 5 years
  • Myocardial infarction during the past 6 months or/and heart failure class III or IVaccording to the New York Heart association's classification;
  • Previous stomach, oesophagus or duodenum surgery;
  • Technical non-feasibility in the opinion of the endoscopist;
  • Clinical signs of active infection;
  • Concomitant unstoppable anticoagulant or anti platelet therapy, except for low doseaspirin (≤ 100 mg);
  • Active drugs or alcohol abuse;
  • Pregnancy, lactation (desire to become pregnant during study duration);
  • Enrolment in other clinical studies;
  • Contraindication to general anaesthesia;
  • Other conditions to exclude the subject in investigators opinion;
  • Refusal to sign informed consent. -

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Endoscopic Sleeve Gastroplasty (ESG)
Phase:
Study Start date:
September 24, 2023
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, 00168
    Italy

    Active - Recruiting

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