Exercise, Prediabetes and Diabetes After Renal Transplantation.

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

Detailed Description
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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.

Official Title
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Exercise, Prediabetes and Diabetes After Renal Transplantation.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Exercise and healthy lifestyle recommendations


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and healthy life style recommendations<br>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. | Other: Exercise and healthy lifestyle recommendations<br>* In the present study, renal transplant patients with proven prediabetes will do a planned 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 Tolerant Test (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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral glucose tolerance test (OGTT) | 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. | Baseline and 3 months-12 months, every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | 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. | Baseline and 3 months-12 months, every 3 months | 
| Analitics | 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. | Baseline and 3 months-12 months, every 3 months | 
| Test the reversibility of prediabetes | 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. | Baseline and 3 months-12 months, every 3 months | 
| Cardiorrespiratory fitness test | 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. | Baseline and 3 months-12 months, every 3 months | 
| Anthropometric measures | 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. | Baseline and 3 months-12 months, every 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PreDiabetes, Exercise, Late post transplant Diabetes Mellitus (PTDM), Renal transplantation