PreDiabetesEXPRED-IINCT06576531
Exercise and Prediabetes After Renal Transplantation
A study testing Therapeutic exercise in people with PreDiabetes and Kidney Transplantation, run by University of La Laguna at 1 site in Spain.
Trial summary
The present clinical trial, EXPRED-II, is the continuation of EXPRED-I (NCT04489043). Objective: to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation, as a first step to prevent Post-Transplant Diabetes Mellitus (PTDM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes, Kidney Transplantation
- What is being tested?
- Therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 25 Aug 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- ≥ 12 months post kidney transplant
- Stable renal function in the last 3-6 months
- Prediabetes (abnormal fasting glucose 100-125 mg/dl and/or glucose intolerance 140-199mg/dl)
- Ability to perform exercise
Who cannot join
- Infection, cancer, acute cardiovascular disease, advanced kidney disease, pulmonary hypertension and uncontrolled chronic liver disease.
- Inability to understand the protocol
- Severe psychological illness
- PTDM and/or DM prior to transplantation
- Morbid obesity
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of La Laguna
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
About this study
The present clinical trial, EXPRED-II, is the continuation of EXPRED-I (NCT04489043).
Objective: to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation, as a first step to prevent Post-Transplant Diabetes Mellitus (PTDM).
Methodology: a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice (n=25) or to a stepped ad-hoc designed training intervention (n=25). Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test (OGTT). Patients randomized to exercise will start with aerobic exercise training 5 times/week, 30 min/day for 12 months which may be gradually increased to 60 min/day or combined with strength exercise in the last increment in case of prediabetes persistence. The reversibility/persistence/relapse of prediabetes will be measured with fasting glucose and OGTT every 3 months. The study will last 12 months.
- Conditions
- PreDiabetes, Kidney Transplantation
- Being tested
- Therapeutic exercise
- Keywords
- Adherence, Post-transplant Diabetes Mellitus, Prediabetes, Renal Transplantation, Therapeutic Exercise
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
A stepped training intervention designed ad hoc based on a combination of aerobic and strength exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The experimental group will receive an ad hoc designed stepped exercise intervention supported by adherence monitoring. Receives: Other: Therapeutic exercise |
| Control group | No intervention | The control group will follow standard lifestyle recommendations according to clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversibility of pre-diabetes in kidney transplant population through therapeutic exercise
There is an 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 tolerance test (OGTT) at intermediate time points (0, 3, 6, 9 and 12 months) will be checked in order to increase the intensity and duration of exercise training.
Measured: Baseline and every 3 months (up to 12 months)
Secondary outcomes (3)
Compliance
To ensure compliance, the following measures will be implemented: (a) contact by phone one time per week, (b) individual interview every month and a half 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.
Measured: Baseline and every 1.5 months (up to 12 months)
Analytics
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
Measured: Baseline and every 3 months (up to 12 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.
Measured: Baseline and every 3 months (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start25 Aug 2024
- Primary completion4 Aug 2025
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of La Laguna
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Canaria Instituto de Investigación Sanitaria de Canarias
- Responsible party
- Principal investigator, Raúl Morales Febles, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576531
- Sponsor's protocol ID
- CHUC_2022_40
- Acronym
- EXPRED-II
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Prediabetes After Renal Transplantation
- ClinicalTrials.gov ID
- NCT06576531
- Acronym / sponsor ID
- EXPRED-II / CHUC_2022_40
- Conditions
- PreDiabetes, Kidney Transplantation
- Keywords
- Adherence, Post-transplant Diabetes Mellitus, Prediabetes, Renal Transplantation, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Collaborators
- Fundación Canaria Instituto de Investigación Sanitaria de Canarias
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present clinical trial, EXPRED-II, is the continuation of EXPRED-I (NCT04489043).
Objective: to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation, as a first step to prevent Post-Transplant Diabetes Mellitus (PTDM).
Methodology: a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice (n=25) or to a stepped ad-hoc designed training intervention (n=25). Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test (OGTT). Patients randomized to exercise will start with aerobic exercise training 5 times/week, 30 min/day for 12 months which may be gradually increased to 60 min/day or combined with strength exercise in the last increment in case of prediabetes persistence. The reversibility/persistence/relapse of prediabetes will be measured with fasting glucose and OGTT every 3 months. The study will last 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Therapeutic exerciseThe experimental group will receive an ad hoc designed stepped exercise intervention supported by adherence monitoring. |
| Control group | No intervention | –The control group will follow standard lifestyle recommendations according to clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years
- ≥ 12 months post kidney transplant
- Stable renal function in the last 3-6 months
- Prediabetes (abnormal fasting glucose 100-125 mg/dl and/or glucose intolerance 140-199mg/dl)
- Ability to perform exercise
Key exclusion criteria (5 listed)
- Infection, cancer, acute cardiovascular disease, advanced kidney disease, pulmonary hypertension and uncontrolled chronic liver disease.
- Inability to understand the protocol
- Severe psychological illness
- PTDM and/or DM prior to transplantation
- Morbid obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exerciseA stepped training intervention designed ad hoc based on a combination of aerobic and strength exercises. | Other | Exercise group |
Primary outcome
Reversibility of pre-diabetes in kidney transplant population through therapeutic exercise
Time frame: Baseline and every 3 months (up to 12 months)
There is an 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 tolerance test (OGTT) at intermediate time points (0, 3, 6, 9 and 12 months) will be checked in order to increase the intensity and duration of exercise training.
3 secondary outcomes
Compliance
Time frame: Baseline and every 1.5 months (up to 12 months)
Analytics
Time frame: Baseline and every 3 months (up to 12 months)
Anthropometric measures
Time frame: Baseline and every 3 months (up to 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise in people with PreDiabetes and Kidney Transplantation, run by University of La Laguna at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversibility of pre-diabetes in kidney transplant population through therapeutic exercise (time frame: Baseline and every 3 months (up to 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.