Clinical trial NCT04489043: Exercise, Prediabetes and Diabetes After Renal Transplantation.
Official title: Exercise, Prediabetes and Diabetes After Renal Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: PreDiabetes
Exercise
Late post transplant Diabetes Mellitus (PTDM)
Renal transplantation
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2020-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with prediabetes beyond 12 months after transplantation will be included. Prediabetes will be diagnosed based on fasting glucose levels and oral glucose tolerance tests (OGTT). Patients will be treated with a stepped training intervention, starting with an aerobic exercise training (brisk walking, swimming and cycling) 5 times per week, 30 min/day. Aerobic exercise training will gradually increase to 60 min/day or in combination with anaerobic exercise training in case of persistent prediabetes. The reversibility/persistence of prediabetes will be measured with fasting glucose and OGTTs at every 3 months.
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oral glucose tolerance test (OGTT)
timeFrame: Baseline and 3 months-12 months, every 3 months
Secondary outcomes:
measure: Compliance
timeFrame: Baseline and 3 months-12 months, every 3 months
measure: Analitics
timeFrame: Baseline and 3 months-12 months, every 3 months
measure: Test the reversibility of prediabetes
timeFrame: Baseline and 3 months-12 months, every 3 months
measure: Cardiorrespiratory fitness test
timeFrame: Baseline and 3 months-12 months, every 3 months
measure: Anthropometric measures
timeFrame: Baseline and 3 months-12 months, every 3 months
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: UICEC
state: S/C De TEnerife
Study officials:
affiliation: Hospital Universitario de Canarias
name: Esteban Porrini, MD, PhD
role: STUDY_DIRECTOR
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