Exercise, Prediabetes and Diabetes After Renal Transplantation.
- Conditions
- Diabetes Mellitus
- Interventions
- Other: Exercise and healthy lifestyle recommendations
- Registration Number
- NCT04489043
- Lead Sponsor
- Hospital Universitario de Canarias
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exercise and healthy life style recommendations Exercise and healthy lifestyle recommendations 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.
- Primary Outcome Measures
Name Time Method Oral glucose tolerance test (OGTT) Baseline and 3 months-12 months, every 3 months After a 10-12 h overnight fast, a standard 75-g OGTT with samples taken at 0 min (glucose-insulin) and 120 minutes (glucose) will be performed at screening-baseline and after 3,6,9,12 months. Patients must be clinically stable without conditions that could induce transient hyperglycaemia or insulin resistance, i.e. infections, acute rejection, renal failure or cardiovascular disease. The presence of any of these conditions postponed the test for at least 3 months after full recovery. Also, serum and urinary samples will be taken and storage at -80 degrees.
- Secondary Outcome Measures
Name Time Method Compliance Baseline and 3 months-12 months, every 3 months To ensure compliance, the following measures will be implemented: (a) contact by phone one time per week (at the end of the week) in the first 3 months up to the end of the study, (b) individual interview every month 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.
Anthropometric measures Baseline and 3 months-12 months, every 3 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. The cutt-off values are the standards by the WHO97.
Test the reversibility of prediabetes Baseline and 3 months-12 months, every 3 months There is a n exercise programme to test the impact of this treatment on the reversibility of prediabetes. Thus, the persistance of recurrency of prediabetes assessed by an OGTT at intermediate time points (3, 6 and 9 months) will be checked in order to increase the frequency and duration of aerobic exercise and eventually to add anaerobic/resistance training.
Analitics Baseline and 3 months-12 months, every 3 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.
Cardiorrespiratory fitness test Baseline and 3 months-12 months, every 3 months Cardiopulmonary exercise testing (CPTE) will be performed in a treadmill while collecting expired gases analysis41. The test will begin at low work rates and gradually increased42 until indications to stop are perceived or volitional exhaustion. The workloads selected for participants should be designed with the aim to reach the maximal effort (peak exercise) in the 8-12 minutes interval43. During CPET maximal oxygen uptake (VO2max) is measured, the stronger predictor of CV risk. It is generally expressed as relative (ml/kg/min)44.
Trial Locations
- Locations (1)
UICEC
🇪🇸La Laguna, S/C De TEnerife, Spain