NCT06576531

Exercise and Prediabetes After Renal Transplantation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of La Laguna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present clinical trial, EXPRED-II, is the continuation of EXPRED-I (NCT04489043). Objective: to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation, as a first step to prevent Post-Transplant Diabetes Mellitus (PTDM). Methodology: a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice (n=25) or to a stepped ad-hoc designed training intervention (n=25). Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test (OGTT). Patients randomized to exercise will start with aerobic exercise training 5 times/week, 30 min/day for 12 months which may be gradually increased to 60 min/day or combined with strength exercise in the last increment in case of prediabetes persistence. The reversibility/persistence/relapse of prediabetes will be measured with fasting glucose and OGTT every 3 months. The study will last 12 months.

Conditions

• PreDiabetes
• Kidney Transplantation

Interventions

Type	Name	Description
OTHER	Therapeutic exercise	A stepped training intervention designed ad hoc based on a combination of aerobic and strength exercises.

Timeline

• Start date: 2024-08-25
• Primary completion: 2025-08-04
• Completion: 2026-07-01
• First posted: 2024-08-28
• Last updated: 2025-08-08

Locations

1 site across 1 country: Spain