Exercise, Prediabetes and Diabetes After Renal Transplantation. (EXPRED)

Hospital Universitario de Canarias

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Other: Exercise and healthy lifestyle recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT04489043

EXPRED

Details and patient eligibility

About

This study is designed to evaluate the feasibility of exercise to reverse prediabetes after transplantation to prevent Posttransplantation Diabetes Mellitus (PTDM).

Full description

The hypothesis of the study is that exercise will promote the reversibility to normal glucose metabolism in patients with prediabetes and eventually reduce the incidence of PTDM in renal transplant. The main objective of the study is to induce the reversibility of prediabetes by means of exercise. Additionally, the secondary objectives are: (a) to evaluate the compliance of exercise (b) improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and HDL cholesterol.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years old.
• Renal transplantation: beyond 6-12 months after transplantation with stable renal function
• IFG: 100-125 mg/dl and IGT 140-199 mg/dl.
• Ability or capacity to perform exercise.

Exclusion criteria

• Clinical conditions that preclude the treatment with exercise i.e. clinical instability: active infection, cancer, acute cardiovascular disease, advanced renal disease, pulmonar hypertension, chronic obstructive pulmonary disease, severe reumatological disorders, arthrosis, arthritis limb amputation, etc.
• Inability to understand the protocol.
• Severe psychological disease.
• PTDM.
• Diabetes before transplantation.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Exercise and healthy life style recommendations

Experimental group

Description:

A planned exercise programme to test the impact of this treatment. An Oral Glucose Tolerant Test (OGTT) at intermediate time points in order to increase the frequency and duration of aerobic exercise and eventually to add anaerobic/resistance training.

Treatment:

Other: Exercise and healthy lifestyle recommendations