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Chronic Kidney Disease stage3ADIPO-CKDNCT07309094

Clinical, Morphometric and Biochemical Effects on Adiposopathy Associated With the Use of GLP-1RA in CKD

An observational study of Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by Cardenal Herrera University at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Chronic kidney disease (CKD) is the progressive damage to kidney function, associated with an increased risk of cardiovascular diseases, such as stroke or myocardial infarct, particularly in the most severe stages of CKD, in which the patient requires dialysis. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
GLP-1 receptor agonist, SGLT2 inhibitor and Tirzepatide
How many people
250 participants
Where
1 siteSpain
Study dates
15 Sep 2023to 31 Dec 2028
Phase
Observational
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be assigned to the different groups according to current treatment criteria: SGLT2i: patients with CKD and T2DM with an eGFR ≥20ml/min/1.73m2; patients with CKD and eGFR ≥20ml/min/1.73m2, accompanied by an urinary albumin-to-creatinine ratio (ACR) ≥200mg/g; patients with CKD and heart failure, irrespective of level of albuminuria; or subjects with CKD and eGFR 20-45ml/min/1.73m2, with ACR <200mg/g. GLP-1RA/tirzepatide: In patients with T2D and CKD who have not achieved individualized glycemic targets despite use of metformin and SGLT2i treatment, or who are unable to use those medications. Other treatments: patients not meeting the criteria to be treated with SGLT2i or GLP-1RA/tirzepatide

Who may be able to join

  • > or = 18 years of age
  • diagnosed with CKD in stages G1, G2, G3a, G3b, and G4, not candidate for dialysis
  • had uncontrolled T2DM, CVDs and/or obesity
  • willing to participate in the study and sign informed consent

Who cannot join

  • Age <18 years
  • pregnancy
  • CKD in stage G5 or G4 candidate for dialysis
  • neuropsychiatric diseases preventing the patient from understanding the benefits/risks associated with the project
  • refusal to participate and/or consent revocation were considered as exclusion criteria

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ana Checa-Ros, MD, PhD contact

+34 961369000 ext. 64341

ana.checaros@uchceu.es

Luis D'Marco, MD, PhD contact

+34 961369000 ext. 64541

luis.dmarcogascon@uchceu.es

Spain1 site, 1 recruiting

  • Vithas Valencia Consuelo

    Valencia, Valencia, 46007

    Luis D'Marco, MD, PhD, +34 96 317 78 00, luis.dmarcogascon@uchceu.es

    Luis D'Marco, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: Clinical, Morphometric and Biochemical Effects on Adiposopathy Associated With the Use of GLP-1 Receptor Agonists in Chronic Kidney Disease

Chronic kidney disease (CKD) is the progressive damage to kidney function, associated with an increased risk of cardiovascular diseases, such as stroke or myocardial infarct, particularly in the most severe stages of CKD, in which the patient requires dialysis. Several risk factors are reported for CKD, such as diabetes mellitus, obesity and hypertension. One of the most increasingly recognized risk factors is the fat tissue malfunction, known as adiposopathy. The accumulation of fat tissue around the organs in conditions of obesity or diabetes accelerates the production of pro-inflammatory factors that may worsen the kidney and heart damage. New antidiabetic medications, such as glucagon-like peptide-1 receptor agonists (GLP-1RA), have proven beneficial effects on the kidney and heart due to several mechanisms, including anti-inflammatory actions and a potential action on the fat tissue.

The aim of this study is to assess the link between adiposopathy and CKD, by investigating the changes in adiposopathy measures throughout treatment with GLP-1RA to a sample of patients with CKD.

Read the detailed description

Chronic kidney disease (CKD) is defined as an irreversible abnormality of kidney structure and/or function lasting for more than three months. CKD is a major global health burden, affecting over 10% of the worldwide population and representing a leading cause of morbidity and mortality. Its progression to end-stage kidney disease (ESKD) drastically increases cardiovascular risk and is associated with a five-year survival rate of only approximately 50%. The principal risk factors for CKD-hypertension, obesity and type 2 diabetes (T2DM) in particular-are intrinsically linked through the dysfunction of fat/adipose tissue (AT), also known as adiposopathy.

Adiposopathy is a key driver of cardiorenal risk in CKD. Evidence from bioimpedance, imaging techniques (CT, MRI), and molecular biology studies confirm that alterations in adipose tissue-including its quantity, distribution (e.g., perirenal, epicardial), radiodensity, and the secretion of pro-inflammatory adipokines-are powerful triggers of cardiorenal damage and mortality in these patients. This understanding frames obesity, T2DM, cardiovascular diseases (CVDs), and CKD as different manifestations of a shared spectrum, now termed adiposity-based chronic disease (ABCD), necessitating an "adipocentric" therapeutic approach.

One hallmark feature of adiposopathy is the reprogramming and increase in size of certain region-specific adipose tissue. Perivisceral adipose tissue plays a pivotal role in adiposity-based chronic diseases as it releases adipokines and cytokines that not only contribute to the systemic pro-inflammatory and oxidative stress processes but may also influence the function of the organs surrounded by this tissue.

GLP-1RA stimulates the receptor for glucagon-like peptide-1 (GLP-1), an incretin-like hormone released in the large intestine that reduces serum glucose concentrations by stimulating the glucose-dependent release of insulin, inhibiting the hypersecretion of glucagon (except in hypoglycemia periods) and promoting satiety. GLP-1RA reduced the incidence of cardiovascular death in patients with T2DM compared with placebo and decreased the incidence of major kidney events, also reducing the progression of kidney dysfunction and the risk of death. In animals, the observed morphological changes generated by GLP-1RA could be underlined by potential actions on adipose tissue remodeling, as these drugs upregulated the expression of AT-browning related genes in perivisceral white adipose tissue from murine models, although the transcriptomic effects from GLP-1RA on the adiposopathy process are still unknown.

Being tested
GLP-1 receptor agonist, SGLT2 inhibitor, Tirzepatide, Other drugs
Keywords
chronic kidney disease, type 2 diabetes mellitus, GLP-1RA, adiposopathy, perivisceral adipose tissue, perirenal adipose tissue, inflammation
Medical subject headings
Renal Insufficiency, Chronic, Obesity, Diabetes Mellitus, Type 2, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLP-1 receptor agonistDrug

    Also called semaglutide, liraglutide, dulaglutide, exenatide

    Semaglutide: weekly subcutaneous administration, starting dose 0.25mg, maintenance dose 1mg

  • SGLT2 inhibitorDrug

    Also called dapagliflozin, empagliflozin, canagliflozin

    dapagliflozin: oral administration from 5 to 10mg/day

  • TirzepatideDrug

    subcutaneous injection: starting dose 2.5 mg, maintenance 5mg (weekly administration)

  • Other drugsDrug

    Also called ARBs, ACE inhibitors, Metformin, DPP4i

    Patients not under SGLT2i or GLP-1RA influence, but receiving other treatments which are part of CKD standard care: mineralocorticoid receptor agonists, metformin, ACE inhibitors, ARBs...

Study groups in NCT07309094
Study groupRoleWhat they receive
GLP-1RA CohortPatients receiving GLP-1RA, mainly semaglutide: weekly administration, subcutaneous form, from 0.25mg (starting dose) to 1mg (maintenance dose) with monthly increase (0.25-0.5-1mg)
Receives: Drug: GLP-1 receptor agonist; Drug: SGLT2 inhibitor
SGLT2i CohortThere will also be another comparative group of patients under SGLT2i
Receives: Drug: GLP-1 receptor agonist; Drug: SGLT2 inhibitor
Other treatmentsPatients not under SGLT2i or GLP-1RA/Tirzepatide influence, but receiving other treatments that are part of CKD and diabetes standard care
Dual GIP GLP-1RAPatients receiving tirzepatide: weekly administration, subcutaneous form, starting dose 2.5mg, maintenance 5mg
Receives: Drug: Tirzepatide; Drug: Other drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ultrasonography change in perirenal adipose tissue thickness

    Change in perirenal adipose tissue thickness as measured with ultrasonography

    Measured: 16 months

  2. Change in estimated glomerular filtration rate

    Change in eGFR as per the CKD-EPI formula

    Measured: 16 months

Secondary outcomes (10)

  1. Ultrasonographic Change in epicardial adipose tissue thickness

    Change in epicardial adipose tissue thickness as measured with ultrasonography

    Measured: 16 months

  2. Change in serum leptin levels

    Serum leptin levels measured with proteomic analysis

    Measured: 16 months

  3. Change in visceral fat area

    Changes in visceral fat area (cm2) as measured with body composition measures (bioimpedance)

    Measured: 16 months

  4. Ultrasonographic Change in subcutaneous adipose tissue

    Change in subcutaneous adipose tissue thickness as measured with ultrasonography

    Measured: 16 months

  5. Ultrasonographic Change in preperitoneal adipose tissue thickness

    Change in preperitoneal adipose tissue thickness as measured with ultrasonography

    Measured: 16 months

  6. Ultrasonographic Change in intrahepatic adipose tissue

    Change in intrahepatic adipose tissue echogenicity

    Measured: 16 months

  7. Change in subcutaneous fat area

    Change in subcutaneous fat area (cm2) as measured with bioimpedance

    Measured: 16 months

  8. Changes in muscle mass (kg)

    Changes in muscle mass as measured with bioimpedance

    Measured: 16 months

  9. Change in serum adiponectin levels

    Serum adiponectin levels measured with proteomic analysis

    Measured: 16 months

  10. Change in urinary levels of Kidney Injury Molecule-1

    Change in urinary levels of KIM-1 measured with ELISA, as an early marker of kidney damage

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start15 Sep 2023
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07309094
Sponsor's protocol ID
23/424
Acronym
ADIPO-CKD
Status last verified
Dec 2025
First submitted
3 Dec 2025
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Due to ethical restrictions and in accordance with General Protection Data Regulation, no identifiable patient information will be shared.

Publications

  • Zhao L, Li W, Zhang P, Wang D, Yang L, Yuan G. Liraglutide induced browning of visceral white adipose through regulation of miRNAs in high-fat-diet-induced obese mice. Endocrine. 2024 Jul;85(1):222-232. doi: 10.1007/s12020-024-03734-2. Epub 2024 Feb 20.

    PubMed 38378894

  • Ying Y, Zhu H, Liang Z, Ma X, Li S. GLP1 protects cardiomyocytes from palmitate-induced apoptosis via Akt/GSK3b/b-catenin pathway. J Mol Endocrinol. 2015 Dec;55(3):245-62. doi: 10.1530/JME-15-0155. Epub 2015 Sep 18.

    PubMed 26386043

  • Carraro-Lacroix LR, Malnic G, Girardi AC. Regulation of Na+/H+ exchanger NHE3 by glucagon-like peptide 1 receptor agonist exendin-4 in renal proximal tubule cells. Am J Physiol Renal Physiol. 2009 Dec;297(6):F1647-55. doi: 10.1152/ajprenal.00082.2009. Epub 2009 Sep 23.

    PubMed 19776173

  • Perkovic V, Tuttle KR, Rossing P, Mahaffey KW, Mann JFE, Bakris G, Baeres FMM, Idorn T, Bosch-Traberg H, Lausvig NL, Pratley R; FLOW Trial Committees and Investigators. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024 Jul 11;391(2):109-121. doi: 10.1056/NEJMoa2403347. Epub 2024 May 24.

    PubMed 38785209

  • Giugliano D, Maiorino MI, Bellastella G, Longo M, Chiodini P, Esposito K. GLP-1 receptor agonists for prevention of cardiorenal outcomes in type 2 diabetes: An updated meta-analysis including the REWIND and PIONEER 6 trials. Diabetes Obes Metab. 2019 Nov;21(11):2576-2580. doi: 10.1111/dom.13847. Epub 2019 Aug 28.

    PubMed 31373167

  • D'Marco L, Puchades MJ, Panizo N, Romero-Parra M, Gandia L, Gimenez-Civera E, Perez-Bernat E, Gonzalez-Rico M, Gorriz JL. Cardiorenal Fat: A Cardiovascular Risk Factor With Implications in Chronic Kidney Disease. Front Med (Lausanne). 2021 May 25;8:640814. doi: 10.3389/fmed.2021.640814. eCollection 2021.

    PubMed 34113631

  • Ku E, Lee BJ, Wei J, Weir MR. Hypertension in CKD: Core Curriculum 2019. Am J Kidney Dis. 2019 Jul;74(1):120-131. doi: 10.1053/j.ajkd.2018.12.044. Epub 2019 Mar 19.

    PubMed 30898362

  • Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.

    PubMed 19896746

  • Khan MZ, Syed M, Osman M, Faisaluddin M, Sulaiman S, Farjo PD, Khan MU, Agrawal P, Alharbi A, Khan SU, Munir MB, Balla S. Contemporary Trends and Outcomes in Patients With ST-Segment Elevation Myocardial Infarction and End-Stage Renal Disease on Dialysis: Insight from the National Inpatient Sample. Cardiovasc Revasc Med. 2020 Dec;21(12):1474-1481. doi: 10.1016/j.carrev.2020.05.004. Epub 2020 May 11.

    PubMed 32444271

  • Moisi MI, Bungau SG, Vesa CM, Diaconu CC, Behl T, Stoicescu M, Toma MM, Bustea C, Sava C, Popescu MI. Framing Cause-Effect Relationship of Acute Coronary Syndrome in Patients with Chronic Kidney Disease. Diagnostics (Basel). 2021 Aug 23;11(8):1518. doi: 10.3390/diagnostics11081518.

    PubMed 34441451

  • Artzi-Medvedik R, Kob R, Fabbietti P, Lattanzio F, Corsonello A, Melzer Y, Roller-Wirnsberger R, Wirnsberger G, Mattace-Raso F, Tap L, Gil P, Martinez SL, Formiga F, Moreno-Gonzalez R, Kostka T, Guligowska A, Arnlov J, Carlsson AC, Freiberger E, Melzer I; SCOPE investigators. Impaired kidney function is associated with lower quality of life among community-dwelling older adults : The screening for CKD among older people across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):340. doi: 10.1186/s12877-020-01697-3.

    PubMed 33008306

  • George LK, Koshy SKG, Molnar MZ, Thomas F, Lu JL, Kalantar-Zadeh K, Kovesdy CP. Heart Failure Increases the Risk of Adverse Renal Outcomes in Patients With Normal Kidney Function. Circ Heart Fail. 2017 Aug;10(8):e003825. doi: 10.1161/CIRCHEARTFAILURE.116.003825.

    PubMed 28765150

  • GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.

    PubMed 32061315

  • Foreman KJ, Marquez N, Dolgert A, Fukutaki K, Fullman N, McGaughey M, Pletcher MA, Smith AE, Tang K, Yuan CW, Brown JC, Friedman J, He J, Heuton KR, Holmberg M, Patel DJ, Reidy P, Carter A, Cercy K, Chapin A, Douwes-Schultz D, Frank T, Goettsch F, Liu PY, Nandakumar V, Reitsma MB, Reuter V, Sadat N, Sorensen RJD, Srinivasan V, Updike RL, York H, Lopez AD, Lozano R, Lim SS, Mokdad AH, Vollset SE, Murray CJL. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. Lancet. 2018 Nov 10;392(10159):2052-2090. doi: 10.1016/S0140-6736(18)31694-5. Epub 2018 Oct 16.

    PubMed 30340847

  • Borg R, Carlson N, Sondergaard J, Persson F. The Growing Challenge of Chronic Kidney Disease: An Overview of Current Knowledge. Int J Nephrol. 2023 Mar 1;2023:9609266. doi: 10.1155/2023/9609266. eCollection 2023.

    PubMed 36908289

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by Cardenal Herrera University 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 4 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: looking for participants now, as of the sponsor's last update on 30 Dec 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?

Contact Ana Checa-Ros, MD, PhD (+34 961369000 ext. 64341, ana.checaros@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasonography change in perirenal adipose tissue thickness (time frame: 16 months). The study lists 2 primary outcomes in all. 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 NCT07309094, which also lists 16 linked publications.

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 30 Dec 2025.

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