Exercise, Prediabetes and Diabetes After Renal Transplantation.
NCT ID: NCT04489043
Last Updated: 2020-07-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-09-05
Study Completion Date
2021-10-01
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).
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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.
Conditions
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Diabetes Mellitus
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
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 Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Exercise and healthy lifestyle recommendations
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
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.
* 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.
* Inability to understand the protocol.
* Severe psychological disease.
* PTDM.
* Diabetes before transplantation.
Minimum Eligible Age
18 Years
Maximum Eligible Age
110 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Sponsor Role
collaborator
Hospital Universitario de Canarias
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Esteban Porrini, MD, PhD
Role: STUDY_DIRECTOR
Hospital Universitario de Canarias
Locations
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UICEC
San Cristóbal de La Laguna, S/C de TEnerife, Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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Reference Type
DERIVED
Other Identifiers
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EXPRED
Identifier Type: -
Identifier Source: org_study_id
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