ADIPO-CKD

Recruiting

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

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

Lead sponsor

Cardenal Herrera University

Assets

Dulaglutide / Exenatide / GLP-1 / incretin class catch-all / Liraglutide / Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Enrollment

250

estimated

Study population

Chronic kidney disease, Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•Ultrasonography change in perirenal adipose tissue thickness•EGFR, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07309094

Org study ID23/424

Timeline

Milestones

Study start2023-09-15actual

Study first posted2025-12-30actual

Last update posted2025-12-30actual

Primary completion2027-07-31estimated

Study completion2028-12-31estimated

Assets

Investigational agents

Dulaglutide Exenatide GLP-1 / incretin class catch-all Liraglutide Semaglutide Tirzepatide

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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

Inclusion criteria

•> 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

Exclusion criteria

•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

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Renal / kidney

MASH / liver

Weight & body composition

7 endpoints

Primary/protocol endpoint

Ultrasonography change in perirenal adipose tissue thickness

Time frame:16 months

change from baseline, improvement

Secondary/protocol endpoint

Ultrasonographic Change in epicardial adipose tissue thickness

Time frame:16 months

change from baseline, improvement

Secondary/protocol endpoint

Change in visceral fat area

Time frame:16 months

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Ultrasonographic Change in subcutaneous adipose tissue

Time frame:16 months

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Ultrasonographic Change in preperitoneal adipose tissue thickness

Time frame:16 months

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in subcutaneous fat area

Time frame:16 months

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in muscle mass (kg)

Time frame:16 months

Lean mass

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Ultrasonographic Change in intrahepatic adipose tissue

Time frame:16 months

change from baseline, improvement

Renal / kidney

2 endpoints

Primary/protocol endpoint

Change in estimated glomerular filtration rate

Time frame:16 months

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in urinary levels of Kidney Injury Molecule-1

Time frame:16 months

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change in serum leptin levels

Time frame:16 months

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

Change in serum adiponectin levels

Time frame:16 months

Adiponectin, change

change from baseline, improvement

Other/protocol endpoint

Change in systemic inflammation markers

Time frame:16 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other/protocol endpoint

Change in systemic inflammation markers

Time frame:16 months

change from baseline, improvement

Other/protocol endpoint

Change in systemic inflammation markers

Time frame:16 months

change from baseline, improvement

Publications (15)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes.
The New England journal of medicine2024 Jul 11PMID38785209doi:10.1056/NEJMoa2403347via CT.gov background
Liraglutide induced browning of visceral white adipose through regulation of miRNAs in high-fat-diet-induced obese mice.
Endocrine2024 Jul (month)PMID38378894doi:10.1007/s12020-024-03734-2via CT.gov background
The Growing Challenge of Chronic Kidney Disease: An Overview of Current Knowledge.
International journal of nephrology2023 (year)PMID36908289doi:10.1155/2023/9609266via CT.gov background
Framing Cause-Effect Relationship of Acute Coronary Syndrome in Patients with Chronic Kidney Disease.
Diagnostics (Basel, Switzerland)2021 Aug 23PMID34441451doi:10.3390/diagnostics11081518via CT.gov background
Cardiorenal Fat: A Cardiovascular Risk Factor With Implications in Chronic Kidney Disease.
Frontiers in medicine2021 (year)PMID34113631doi:10.3389/fmed.2021.640814via CT.gov background
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.
Cardiovascular revascularization medicine : including molecular interventions2020 Dec (month)PMID32444271doi:10.1016/j.carrev.2020.05.004via CT.gov background
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 geriatrics2020 Oct 2PMID33008306doi:10.1186/s12877-020-01697-3via CT.gov background
Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.
Lancet (London, England)2020 Feb 29PMID32061315doi:10.1016/S0140-6736(20)30045-3via CT.gov background
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, obesity & metabolism2019 Nov (month)PMID31373167doi:10.1111/dom.13847via CT.gov background
Hypertension in CKD: Core Curriculum 2019.
American journal of kidney diseases : the official journal of the National Kidney Foundation2019 Jul (month)PMID30898362doi:10.1053/j.ajkd.2018.12.044via CT.gov background
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 (London, England)2018 Nov 10PMID30340847doi:10.1016/S0140-6736(18)31694-5via CT.gov background
Heart Failure Increases the Risk of Adverse Renal Outcomes in Patients With Normal Kidney Function.
Circulation. Heart failure2017 Aug (month)PMID28765150doi:10.1161/CIRCHEARTFAILURE.116.003825via CT.gov background
GLP1 protects cardiomyocytes from palmitate-induced apoptosis via Akt/GSK3b/b-catenin pathway.
Journal of molecular endocrinology2015 Dec (month)PMID26386043doi:10.1530/JME-15-0155via CT.gov background
Global estimates of the prevalence of diabetes for 2010 and 2030.
Diabetes research and clinical practice2010 Jan (month)PMID19896746doi:10.1016/j.diabres.2009.10.007via CT.gov background
Regulation of Na+/H+ exchanger NHE3 by glucagon-like peptide 1 receptor agonist exendin-4 in renal proximal tubule cells.
American journal of physiology. Renal physiology2009 Dec (month)PMID19776173doi:10.1152/ajprenal.00082.2009via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.