Exercise, Prediabetes and Diabetes After Renal Transplantation.

NCT04489043 | Unknown

• 1 other identifier: EXPRED
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

PreDiabetes; Exercise; Late post transplant Diabetes Mellitus (PTDM); Renal transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Compliance

  Baseline and 3 months-12 months, every 3 months

• Analitics

  Baseline and 3 months-12 months, every 3 months

• Test the reversibility of prediabetes

  Baseline and 3 months-12 months, every 3 months

• Cardiorrespiratory fitness test

  Baseline and 3 months-12 months, every 3 months

• Anthropometric measures

  Baseline and 3 months-12 months, every 3 months

Study Arms (1)

Exercise and healthy life style recommendations

EXPERIMENTAL

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

Interventions

Exercise and healthy lifestyle recommendations 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.

Exercise and healthy life style recommendations

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

UICEC

San Cristóbal de La Laguna, S/C de TEnerife, 38320, Spain

RECRUITING

Related Publications (44)

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MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Esteban Porrini, MD, PhD

  Hospital Universitario de Canarias

  STUDY DIRECTOR

Central Study Contacts

Raul Morales Febles

CONTACT

+34 922678115; rmf1313@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 28, 2020
• Study Start: September 5, 2019
• Primary Completion: December 5, 2019
• Study Completion: October 1, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)