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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04489043
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Exercise and healthy lifestyle recommendations Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise, Prediabetes and Diabetes After Renal Transplantation.
Actual Study Start Date : September 5, 2019
Actual Primary Completion Date : December 5, 2019
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise and healthy life style 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.
Other: Exercise and healthy lifestyle recommendations
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.




Primary Outcome Measures :
  1. Oral glucose tolerance test (OGTT) [ Time Frame: 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 :
  1. Compliance [ Time Frame: 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.

  2. Analitics [ Time Frame: 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.

  3. Test the reversibility of prediabetes [ Time Frame: 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.

  4. Cardiorrespiratory fitness test [ Time Frame: 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.

  5. Anthropometric measures [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489043


Contacts
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Contact: Raul Morales Febles +34 922678115 rmf1313@gmail.com

Locations
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Spain
UICEC Recruiting
La Laguna, S/C De TEnerife, Spain, 38320
Contact: Raul Morales Febles, Master    +34 922678115    rmf1313@gmail.com   
Contact: Esteban Porrini, MD., PhD    +34 922678116    estebanporrini72@hotmail.com   
Sponsors and Collaborators
Hospital Universitario de Canarias
Instituto de Salud Carlos III
Investigators
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Study Director: Esteban Porrini, MD, PhD Hospital Universitario de Canarias
Publications of Results:

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Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT04489043    
Other Study ID Numbers: EXPRED
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitario de Canarias:
PreDiabetes
Exercise
Late post transplant Diabetes Mellitus (PTDM)
Renal transplantation
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia