Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

Obesity is well-recognized as an independent risk factor for chronic kidney disease (CKD) including end-staged kidney disease (ESKD). In people with ESKD, obesity can preclude access to lifesaving kidney transplantation. Of solid organ transplant programs in Canada, 80% exclude people with obesity (based upon body mass index or BMI), due to a potential risk of perioperative complications and post-transplant mortality.

Losing weight for kidney transplantation can, however, be extremely difficult. Medications that can promote weight loss in other populations including glucagon-like peptide 1 receptor agonists (GLP-1RA; liraglutide, semaglutide, and dulaglutide) and glucose-dependent insulinotropic polypeptide (GIP-1RA)/GLP-1RAs (tirzepatide), have not been studied in devoted trials of advanced CKD participants, and their efficacy and safety remain unclear.

Nutritional advice is often very difficult to follow when trying to balance kidney and diabetes diets (e.g. potassium), and if diets are too restrictive, there may be protein-energy wasting which could be detrimental to patients. People with high-risk CKD frequently live with functional impairment which can limit exercise. Weight loss programs can be cost prohibitive to those who are already socioeconomically disadvantaged.

A vanguard is needed before a large, multicentered RCT: A feasibility study will allow us to ensure that we can recruit a sufficient sample of participants into our trial, that our trial processes are inclusive, and that they are acceptable to patients. In the vanguard phase of our trial, we will answer the following questions:

1. Is participant recruitment into a large multi-centered trial feasible? 2. Will participants remain adherent to their assigned treatment arm over 26 weeks of study? 3. Will participants find our program acceptable? 4. Will safety events preclude us from testing our intervention in a larger RCT?

• Adherence to Scheduled Coaching Visits [Срок оценки: 12 months]
• Adherence to GLP-1RA Therapy [Срок оценки: 12 months]
• Recruitment of ≥20 Participants in First 12 Weeks [Срок оценки: First 12 weeks]
• Recruitment Per Site Within 12 Weeks [Срок оценки: First 12 weeks]
• Incidence of Acute Kidney Injury [Срок оценки: 12 months]
• Incidence of Hypoglycemia [Срок оценки: 12 months]
• Incidence of Gastrointestinal Side Effects [Срок оценки: 12 months]
• Change in Dalhousie Clinical Frailty Scale Classification [Срок оценки: 26 weeks]
• Change in SARC-F Score of Sarcopenia [Срок оценки: 26 weeks]
• Change in Body Weight - Smart Scale [Срок оценки: 26 weeks]
• Change in Body Fat - Smart Scale [Срок оценки: 26 weeks]
• Change in Muscle Mass - Smart Scale [Срок оценки: 26 weeks]