Clinical Trial

Exercise and Prediabetes After Renal Transplantation

Study acronym: EXPRED-II
Active, Not Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-26.
Trial Details
NCT Number NCT06576531
Lead Sponsor University of La Laguna
Collaborators: Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Conditions PreDiabetes, Kidney Transplantation
Enrollment 50 participants
Start Date 2024-08-25
Primary Completion 2025-08-04 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-08-08