Exercise and Prediabetes After Renal Transplantation (EXPRED-II)

University of La Laguna

Status

Active, not recruiting

Conditions

Kidney Transplantation

PreDiabetes

Treatments

Other: Therapeutic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT06576531

CHUC_2022_40

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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