Metabolic SyndromeEXREDNCT06576518
Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study
A study testing Therapeutic exercise in people with Metabolic Syndrome and CKD, run by University of La Laguna at 1 site in Spain.
Trial summary
INTRODUCTION: Obesity (OB) and metabolic syndrome (MetS) are risk and progression factors for chronic kidney disease (CKD). However, the effect of OB/MetS intervention with exercise on renal function progression and proteinuria is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, CKD
- 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
- 10 Jun 2021to 27 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- age >18 years
- CKD of diverse aetiologies
- estimated GFR ≥ 30 ml/min
- BMI ≥ 27 kg/m2 associated to MetS or diabetes mellitus (DM)
- stable renal function for at least 6 months before screening
- ability to perform exercise
Who cannot join
- clinical conditions that exclude exercise therapy such as clinical instability, active infection, cancer, acute cardiovascular disease, advanced CKD, pulmonary hypertension, or limb amputations
- inability to understand the protocol
- severe psychiatric illness
- allergy to iodine
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de La Laguna
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
About this study
Official title: Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study (EXRED)
INTRODUCTION: Obesity (OB) and metabolic syndrome (MetS) are risk and progression factors for chronic kidney disease (CKD). However, the effect of OB/MetS intervention with exercise on renal function progression and proteinuria is unknown.
OBJECTIVE: To analyse the effect of therapeutic exercise on MetS and main renal outcomes in patients with CKD.
METHODOLOGY: This is a 6-month prospective exploratory study. Patients with stablished CKD (1-4) and MetS were treated with individualised incremental exercise (aerobic and resistance). Simultaneously, a plan of adherence was set up to promote compliance. Renal and metabolic outcomes were collected. The main renal parameters were: proteinuria, in isolated urine samples, and glomerular filtration rate (GFR), measured by iohexol DBS, at 0, 3 and 6 months. At the same time points, metabolic outcomes were measured: weight, dyslipidemia, insulin resistance and hypertension.
- Conditions
- Metabolic Syndrome, CKD
- Being tested
- Therapeutic exercise
- Keywords
- Adherence, Chronic Kidney Disease, Metabolic Syndrome, Obesity, Therapeutic Exercise
- Medical subject headings
- Metabolic Syndrome, Renal Insufficiency, Chronic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
An individualised incremental exercise programme was simultaneously supported by an adherence plan to assess and promote compliance.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Patients with established CKD (1-4) and MS were treated with individualised incremental exercise (aerobic and resistance) for 6 months. Receives: Other: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Glomerular filtration rate (GFR) and urine abulmin-creatinine ratio (UACR).
GFR and UACR were measured at baseline, 3 and 6 months, with the gold standard method of plasma clearance of iohexol (DBS technique) and urine analysis (isolated urine samples), respectively. The researchers expect a change in terms of GFR (improvement of hyperfiltration) and UACR reduction compared to baseline.
Measured: Baseline, 3 and 6 months
Secondary outcomes (2)
Changes in body weight and MetS traits (Analytics).
Monthly, 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.Weight changes >5% were expected at 6 months.
Changes in Mets traits as a relative change from baseline (%) or as success in falling below the cut-off point of the MetS definition. 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, month 3 and 6.
Compliance-adherence
To ensure compliance, the following measures will be implemented: (a) contact by phone one time per week, (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, analysing the time, frequency, burned calories, velocity and distance, among others, to reach the established goal prescribed by the physiotherapist.
Measured: Monthly
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 start10 Jun 2021
- Primary completion2 Dec 2021
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- NCT06576518
- Sponsor's protocol ID
- CHUC_2021_32
- Acronym
- EXRED
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rivero Martin O, Morales Febles R, Delgado Mallen PI, Reseghetti E, Miquel Rodriguez RM, Estupinan Torres S, Cobo Caso MA, Cruz C, Diaz Martin L, Gonzalez Martin AR, Sanchez Baez DJ, Hernandez Marrero DJ, Luis Lima S, Porrini E. Exercise Intervention in Patients with Metabolic Syndrome and Renal Disease: A Prospective Study (EXRED). Nephron. 2026;150(3):141-155. doi: 10.1159/000549072. Epub 2025 Nov 27.
PubMed 41308049
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study (EXRED)
- ClinicalTrials.gov ID
- NCT06576518
- Acronym / sponsor ID
- EXRED / CHUC_2021_32
- Conditions
- Metabolic Syndrome, CKD
- Keywords
- Adherence, Chronic Kidney Disease, Metabolic Syndrome, Obesity, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Collaborators
- Fundación Canaria Instituto de Investigación Sanitaria de Canarias
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 27 May 2024 (actual)
- 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.
INTRODUCTION: Obesity (OB) and metabolic syndrome (MetS) are risk and progression factors for chronic kidney disease (CKD). However, the effect of OB/MetS intervention with exercise on renal function progression and proteinuria is unknown.
OBJECTIVE: To analyse the effect of therapeutic exercise on MetS and main renal outcomes in patients with CKD.
METHODOLOGY: This is a 6-month prospective exploratory study. Patients with stablished CKD (1-4) and MetS were treated with individualised incremental exercise (aerobic and resistance). Simultaneously, a plan of adherence was set up to promote compliance. Renal and metabolic outcomes were collected. The main renal parameters were: proteinuria, in isolated urine samples, and glomerular filtration rate (GFR), measured by iohexol DBS, at 0, 3 and 6 months. At the same time points, metabolic outcomes were measured: weight, dyslipidemia, insulin resistance and hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Therapeutic exercisePatients with established CKD (1-4) and MS were treated with individualised incremental exercise (aerobic and resistance) for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age >18 years
- CKD of diverse aetiologies
- estimated GFR ≥ 30 ml/min
- BMI ≥ 27 kg/m2 associated to MetS or diabetes mellitus (DM)
- stable renal function for at least 6 months before screening
Key exclusion criteria (4 listed)
- clinical conditions that exclude exercise therapy such as clinical instability, active infection, cancer, acute cardiovascular disease, advanced CKD, pulmonary hypertension, or limb amputations
- inability to understand the protocol
- severe psychiatric illness
- allergy to iodine
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 exerciseAn individualised incremental exercise programme was simultaneously supported by an adherence plan to assess and promote compliance. | Other | Exercise group |
Primary outcome
Changes in Glomerular filtration rate (GFR) and urine abulmin-creatinine ratio (UACR).
Time frame: Baseline, 3 and 6 months
GFR and UACR were measured at baseline, 3 and 6 months, with the gold standard method of plasma clearance of iohexol (DBS technique) and urine analysis (isolated urine samples), respectively. The researchers expect a change in terms of GFR (improvement of hyperfiltration) and UACR reduction compared to baseline.
2 secondary outcomes
Changes in body weight and MetS traits (Analytics).
Time frame: Baseline, month 3 and 6.
Compliance-adherence
Time frame: Monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 41308049Rivero Martin O, Morales Febles R, Delgado Mallen PI, Reseghetti E, Miquel Rodriguez RM, Estupinan Torres S, Cobo Caso MA, Cruz C, Diaz Martin L, Gonzalez Martin AR, Sanchez Baez DJ, Hernandez Marrero DJ, Luis Lima S, Porrini E. Exercise Intervention in Patients with Metabolic Syndrome and Renal Disease: A Prospective Study (EXRED). Nephron. 2026;150(3):141-155. doi: 10.1159/000549072. Epub 2025 Nov 27.
- 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 Metabolic Syndrome and CKD, 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 28 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Glomerular filtration rate (GFR) and urine abulmin-creatinine ratio (UACR). (time frame: Baseline, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06576518, which also lists 1 linked publication.
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 28 Aug 2024.