Exercise and Prediabetes After Renal Transplantation

NCT06576531 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-08-08

No results posted yet for this study

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

Interventions

OTHER

Therapeutic exercise

A stepped training intervention designed ad hoc based on a combination of aerobic and strength exercises.

Sponsors & Collaborators

  • Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias

    collaborator OTHER
  • University of La Laguna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-25
Primary Completion
2025-08-04
Completion
2026-07-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576531 on ClinicalTrials.gov