Exercise and Prediabetes After Renal Transplantation

NCT06576531 | Active Not Recruiting

• 1 other identifier: CHUC_2022_40
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adherence; Post-transplant Diabetes Mellitus; Prediabetes; Renal Transplantation; Therapeutic Exercise

Outcome Measures

Primary Outcomes (1)

• Reversibility of pre-diabetes in kidney transplant population through therapeutic exercise

  There is an exercise programme to test the impact of this treatment on the reversibility of prediabetes. Thus, the persistance of recurrency of prediabetes assessed by an oral glucose tolerance test (OGTT) at intermediate time points (0, 3, 6, 9 and 12 months) will be checked in order to increase the intensity and duration of exercise training.

  Baseline and every 3 months (up to 12 months)

Secondary Outcomes (3)

• Compliance

  Baseline and every 1.5 months (up to 12 months)

• Analytics

  Baseline and every 3 months (up to 12 months)

• Anthropometric measures

  Baseline and every 3 months (up to 12 months)

Study Arms (2)

Exercise group

EXPERIMENTAL

The experimental group will receive an ad hoc designed stepped exercise intervention supported by adherence monitoring.

Other: Therapeutic exercise

Control group

NO INTERVENTION

The control group will follow standard lifestyle recommendations according to clinical practice.

Interventions

Therapeutic exercise OTHER

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

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years
• ≥ 12 months post kidney transplant
• Stable renal function in the last 3-6 months
• Prediabetes (abnormal fasting glucose 100-125 mg/dl and/or glucose intolerance 140-199mg/dl)
• Ability to perform exercise

You may not qualify if:

• Infection, cancer, acute cardiovascular disease, advanced kidney disease, pulmonary hypertension and uncontrolled chronic liver disease.
• Inability to understand the protocol
• Severe psychological illness
• PTDM and/or DM prior to transplantation
• Morbid obesity

Sponsors & Collaborators

• University of La Laguna: lead
• Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias: collaborator

Study Sites (1)

University of La Laguna

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-Physiotherapist

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start: August 25, 2024
• Primary Completion: August 4, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

ES (1)