Exercise and Prediabetes After Renal Transplantation
NCT Number: NCT06576531
Acronym: EXPRED-II
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PreDiabetes|Kidney Transplantation
Interventions: OTHER: Therapeutic exercise
Sponsor: University of La Laguna
Collaborators: Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-07-18
Completion Date: 2026-07
Locations: University of La Laguna, San Cristobal de La laguna, Santa Cruz De Tenerife, 38320, Spain

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.

Primary Outcome Measures: 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 Outcome Measures: Compliance, To ensure compliance, the following measures will be implemented: (a) contact by phone one time per week, (b) individual interview every month and a half to reinforce lifestyle changes and follow all recommended in the exercise prescription; (c) the use of a gadget (xiaomi mi band) to see daily routines of patients and every training prescription; this analyses the time, frequency, burned calories, velocity and distance, among others, to reach the established goal by the physiotherapist., Baseline and every 1.5 months (up to 12 months)|Analytics, To evaluate the improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and HDL cholesterol.hemogram (hematocrit, haemoglobin, white blood count), biochemist tests: creatinine, HbA1c, total, LDL and HDL cholesterol, triglycerides, uric acid, hepatic enzymes (ASAT, ALAT), levels of immunosuppression, albumin, creatinine, albuminuria, proteinuria in an isolated urinary samples, Baseline and every 3 months (up to 12 months)|Anthropometric measures, At baseline and at 3, 6, 9, 12 months: weight in kilograms, height in meters, waist circumference, hip circumference, will be measured. Also, BMI Body mass index (BMI): weight in kilograms divided by the square of the height in meters., Baseline and every 3 months (up to 12 months)