Exercise and Prediabetes After Renal Transplantation

Not Applicable

Active, not recruiting

• Conditions: Kidney Transplantation; PreDiabetes
• Interventions: Other: Therapeutic exercise

• Registration Number: NCT06576531
• Lead Sponsor: University of La Laguna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-18
• Status Verified: 2024-08
• Primary Completion: 2024-08-22
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ≥ 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Therapeutic exercise	The experimental group will receive an ad hoc designed stepped exercise intervention supported by adherence monitoring.

Primary Outcome Measures

Name	Time	Method
Reversibility of pre-diabetes in kidney transplant population through therapeutic exercise	Baseline and every 3 months (up to 12 months)	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.

Secondary Outcome Measures

Name	Time	Method
Compliance	Baseline and every 1.5 months (up to 12 months)	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.
Analytics	Baseline and every 3 months (up to 12 months)	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
Anthropometric measures	Baseline and every 3 months (up to 12 months)	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.

Trial Locations

Locations (1)

University of La Laguna; 🇪🇸 San Cristobal de La laguna, Santa Cruz De Tenerife, Spain