CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry (CARTIZ)
Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts (CARTIZ): A Prospective Observational Multi-Institutional Registry of the VAT-Articular-Cardiac-Aging Axis in Adults Exposed to Tirzepatide in Mexico, With Quantitative Knee Cartilage T2 Mapping, Cardiac CT Epicardial Adipose Tissue Radiomic Phenotyping, HLA Stratification, Longitudinal Multi-Frequency Bioimpedance Body Composition, and a Prespecified Surgical Tissue Acquisition Subcohort
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Background and rationale. Tirzepatide, a dual agonist of the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, has demonstrated unprecedented cardiometabolic potency in registration trials (SURPASS, SURMOUNT, SYNERGY-NASH, SUMMIT). Recent evidence has extended the mechanistic reach of the molecule beyond glycemia and weight to specific tissue compartments. The SUMMIT cardiac magnetic resonance substudy demonstrated reduction of left ventricular mass and paracardiac adipose tissue at 52 weeks in heart failure with preserved ejection fraction with obesity. A prespecified diabetes-stratification analysis of SUMMIT established that these structural effects are partially independent of weight change. The SURPASS cardiovascular outcomes trial established cardiovascular superiority of tirzepatide over GLP-1 monoagonism. A recent randomized clinical trial in psoriatic arthritis with overweight or obesity demonstrated articular response at Week 4 when dual incretin agonism was added to IL-17A inhibition, prior to substantial weight loss. The "multi-nutrient-stimulated-hormone" (multi-NuSH) framework now organizing the field articulates the conceptual reach of dual and multi-incretin agonism beyond glycemia. Mechanistic work on human and murine adipocytes establishes direct GIP receptor effects on visceral adipose depots that are biologically distinct from weight-mediated effects. Bibliographic support for each of these statements is provided in the Citations field of this record.
The Mexican off-label access asset. Access to tirzepatide in the United States and Europe is restricted by payer prior-authorization to narrow on-label indications. In Mexico, out-of-pocket access permits a phenotypic breadth of clinical exposure not replicable in sponsor-led trials, including patients who receive tirzepatide for insulin resistance, metabolic hypertension, renal protection, and off-label metabolic indications. This pharmacological natural experiment allows the registry to capture the articular, cardiac, compositional, and aging-biology response to dual GIP/GLP-1 agonism across a clinical breadth sponsor trials cannot access. The window is finite: as label expansion advances, the uniqueness of Mexican off-label exposure attenuates. The registry is positioned to capture this window.
Four-institute architecture. CARTIZ operates through four specialized cores, each led by a qualified investigator at an independent institution, producing endpoints of differentiated resolution and relevance.
Core 1 - Knee Cartilage Imaging Core (Level 3A). Bilateral 3T knee MRI with quantitative T2 mapping at Week 0 and Week 52, performed at Ci3M UAM-Iztapalapa (CONACYT National Laboratory) under Dr. Andres Moron and Dr. Luis Jimenez Angelez departamento de ingenieria en sistemas biomedicos, Facultad de Ingenieria UNAM. All imaging at a single Philips 3T platform with harmonized pulse-sequence parameters. Central overread. 60 evaluable knees at n=30.
Core 2 - Cardiac Imaging Core (Level 3B). Non-contrast cardiac computed tomography with prospective electrocardiographic gating at Week 0 and Week 52, performed at the Instituto Nacional de Cardiología Ignacio Chávez under cardiovascular Co-Principal Investigator Dr. Erick Alexánderson Rosas, Chief of the Departamento de Cardiología Nuclear e Imagen Cardiovascular Molecular. Radiomic phenotyping of epicardial adipose tissue (EAT) following the Imaging Biomarker Standardization Initiative (IBSI) specifications using PyRadiomics, with quantification of EAT volume, mean attenuation (Hounsfield units), attenuation distribution (standard deviation, skewness, kurtosis), and texture features (first-order, gray-level co-occurrence matrix, gray-level run-length matrix, gray-level size-zone matrix, neighborhood gray-tone difference matrix). Fat Attenuation Index (FAI) quantification in the adventitia of proximal left anterior descending, circumflex, and right coronary artery territories per published perivascular FAI methodology. 30 paired cardiac CT studies.
Core 3 - HLA Typing Core (Level 2). Class I (A, B, C) and Class II (DRB1, DQB1, DPB1) HLA typing by PCR-SSO Reverse Luminex at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) Transplant Department under Dr. Mario Vilatoba. Anonymized archival for population comparison and kinship-linkage analysis.
Core 4 - Body Composition Core (Level 4). Multi-frequency bioelectrical impedance analysis (seca mBCA) at six longitudinal timepoints (Week 0, 2, 4, 12, 24, 52) at Universidad La Salle México, capturing visceral adipose tissue trajectory, phase-angle trajectory (an established aging-biology biomarker), appendicular skeletal muscle mass, total body water, extracellular water, and hydration ratios. Available at zero marginal cost to the registry.
Five-level endpoint structure. Endpoints are organized in five levels of differentiated resolution: Level 1 - mechanistic deconvolution (PI-executed, primary); Level 2 - biomarker and HLA stratification (sponsor-executed under MTA, hypothesis-generating); Level 3A - knee structural imaging (Ci3M, PI-executed); Level 3B - cardiac structural imaging (INCar, PI-executed); and Level 4 - body composition and aging biology (La Salle, PI-executed).
Primary co-endpoints. (1) ACR20 response rate at Week 4 in the Mechanistic Analysis Set (MAS), defined as patients with tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI <1.0 kg/m² through Week 4. (2) Proportion of Week-4 ACR20 response mediated by the combined biomarker panel (high-sensitivity C-reactive protein, SERPINB2, dipeptidyl peptidase-4 activity) in the MAS, assessed by the MacKinnon product-of-coefficients method with 10,000 bias-corrected and accelerated bootstrap iterations.
Surgical Tissue Subcohort (prespecified secondary arm). A subset of enrolled participants who undergo clinically indicated cardiac surgery at INCar during registry follow-up (coronary artery bypass grafting, valve replacement, or combined procedures) will be invited to provide specific informed consent for collection of epicardial adipose tissue fragments routinely excised during operative access to the heart (e.g., during aortic root exposure for AVR, coronary target exposure for CABG, or mitral annular exposure for MVR). These fragments are ordinarily discarded as surgical waste. Under this subcohort they are collected intraoperatively, divided into fresh-frozen aliquots (RNAlater, OCT) and formalin-fixed aliquots (10% neutral-buffered formalin), and processed for bulk and/or single-nucleus RNA sequencing, histological characterization, and biobanking for prespecified future analyses. Tissue acquisition does not modify the surgical procedure. Operational launch is contingent on favorable opinion of the INCar Comité de Investigación and Comité de Ética en Investigación for the tissue-specific protocol, formal operational agreement with the INCar Servicio de Cirugía Cardiovascular, and PRS record amendment. This subcohort is declared at initial registration to establish scientific priority for direct human epicardial adipose tissue transcriptomic characterization under dual GIP/GLP-1 receptor agonism - a gap explicitly identified in the multi-NuSH framework and not filled by any currently published or registered study.
Governance and oversight. Independent Scientific Advisory Board (ISAB) with advisory competence over the Statistical Analysis Plan, publication policy, and database lock. Cryptographic provenance infrastructure: SHA-256 hash chain for every biospecimen manifest entry, every DICOM series, and every database snapshot, anchored to an append-only audit log under version control, with three-server email timestamping. Informed consent is modular: each attestation (prospective participation, serum biobanking, HLA typing, knee MRI, cardiac CT, body composition, medical record review, and - for the surgical subcohort - tissue collection) is consented separately within a single document. All data transferred to sponsors is de-identified to HIPAA Safe Harbor and LFPDPPP Mexican standards, with cryptographic separation between re-identification key and transferred dataset.
Intellectual property status. Four United States Provisional Patent Applications are active, filed pro se by the Principal Investigator as micro entity: PROV-001 (64/019,134, 27 March 2026, DPP4-Incretin-SERPIN axis for chondroprotection); PROV-002 (64/031,635, 7 April 2026, BMP/ROCK/DPP4/Mechanosensory axis); PROV-003 (64/039,918, 15 April 2026, cartilage companion biomarkers); PROV-004 (64/043,606, 19 April 2026, HLA-guided GIPR companion diagnostics). All four are referenced as Secondary IDs in this registration.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Julio Granados-Montiel, MD, PhD
- Telefonnummer: +52 5554329237
- E-Mail: juliogram@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Marwin Gutiérrez, MD
Studienorte
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Mexico City
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Mexico City, Mexico City, Mexiko, 01090
- IMSS Clínica Río Magdalena
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Kontakt:
- Julio Granados-Montiel, MD, PhD
- Telefonnummer: +52 5554329237
- E-Mail: juliogram@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
1. Age ≥18 years at the time of informed consent. 2. Currently receiving tirzepatide under an independent clinical indication (type 2 diabetes, insulin resistance, obesity with or without associated metabolic disease, renal protection, metabolic hypertension, or associated off-label metabolic use) prescribed by the treating physician independently of the registry.
3. Presence of at least one objectively documented musculoskeletal manifestation - current or historical - defined as any of: (i) inflammatory arthralgia affecting one or more joints with clinical, imaging, or serological support; (ii) CASPAR-positive psoriatic arthritis; (iii) radiographically documented knee osteoarthritis; (iv) enthesitis on physical examination or ultrasound; (v) documented inflammatory arthropathy of the spine or peripheral joints with a specialist diagnosis.
4. For the retrospective-prospective component: availability of clinical documentation of articular state prior to tirzepatide initiation in the patient's medical record. Documentation may include physical examination notes, imaging, laboratory values, or specialist consultation notes.
5. Signed informed consent for registry enrolment, longitudinal serum biobanking, HLA typing at INCMNSZ, quantitative knee MRI with T2 mapping at Ci3M UAM-Iztapalapa at Week 0 and Week 52, non-contrast cardiac CT at INCar at Week 0 and Week 52, multi-frequency bioelectrical impedance analysis at Universidad La Salle México at six timepoints, and (where applicable) medical record review. Each attestation is consented modularly within a single document.
6. Clinical plan to continue tirzepatide for at least 52 weeks from registry Week 0, based on the treating physician's evaluation of current clinical indication. Discontinuation during follow-up is captured as an outcome variable and does not remove the patient from the registry.
7. Capacity to attend scheduled follow-up visits and to undergo bilateral knee MRI at Ci3M (without severe claustrophobia requiring sedation, without absolute contraindication to MRI - see Exclusion 6) and non-contrast cardiac CT at INCar (without uncontrolled arrhythmia precluding ECG-gated imaging of diagnostic quality).
For the Surgical Tissue Subcohort (Cohort 3) only - additional criteria applied at the time of subcohort enrolment:
8s. Scheduled clinically indicated cardiac surgery at the Instituto Nacional de Cardiología Ignacio Chávez (coronary artery bypass grafting, valve replacement, or combined procedures) during registry follow-up.
9s. Specific additional informed consent for intraoperative collection of epicardial adipose tissue fragments.
Exclusion Criteria:
1. Initiation or modification of a biologic disease-modifying antirheumatic drug (biologic DMARD) or JAK inhibitor within the 12 weeks prior to Week 0, or clinically anticipated initiation or modification during the first 12 weeks of follow-up. Washout may permit re-screening.
2. Major joint surgery within the 3 months prior to Week 0, or planned major joint surgery within the 12 months following Week 0, involving any joint scheduled for evaluation in the registry.
3. Intra-articular corticosteroid or hyaluronic acid injection within the 6 weeks prior to baseline biospecimen collection in any joint. Patients beyond the 6-week washout are eligible.
4. Active malignancy, with the exception of adequately treated non-melanoma skin carcinoma. History of malignancy in remission ≥5 years is permitted at the discretion of the treating investigator.
5. Current pregnancy, lactation, or planned pregnancy within the 12-month observation period.
6. Absolute contraindication to MRI, including non-MRI-compatible cardiac pacemaker or implanted defibrillator, ferromagnetic intracranial vascular clips, non-documented non-MRI-compatible cochlear implants, or other contraindication per the local MRI safety protocol.
7. Systemic rheumatologic disease other than psoriatic arthritis or osteoarthritis requiring active immunomodulation, specifically: seropositive rheumatoid arthritis on biologic therapy, active systemic lupus erythematosus on immunomodulation, active vasculitis on immunosuppression, or other systemic disease whose treatment confounds the inflammatory axis the registry is designed to characterize.
8. Inability to provide informed consent (cognitive impairment, language barrier not resolvable with site interpreter, or other incapacity to understand the protocol), or anticipated inability to complete the 52-week follow-up.
For the Surgical Tissue Subcohort (Cohort 3) only - additional exclusions:
9s. Prior major cardiac surgery resulting in extensive pericardial adhesions that preclude safe intraoperative EAT fragment collection, as assessed by the operating cardiac surgeon.
10s. Emergency cardiac surgery precluding the specific informed consent process.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Retrospective-Prospective
Patients currently under the Principal Investigator's care who are already receiving tirzepatide for an independent clinical indication at the time of registry enrolment, with pre-tirzepatide articular, metabolic, and clinical documentation available in the medical record.
Baseline pre-tirzepatide state is reconstructed retrospectively from structured medical record review under a specific informed consent attestation; Week-0 biospecimen and imaging acquisition is prospective.
Expected n=10-20 from the Principal Investigator's existing patient pool.
Recruitment Status: Not yet recruiting.
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Dual GLP-1 and GIP receptor agonist administered subcutaneously at doses and intervals determined by the treating physician independently of this registry.
The registry does not supply, initiate, modify, or discontinue tirzepatide; exposure is documented from the medical record and patient report.
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Fully Prospective
Patients identified across the three clinical sites (IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, private practice in Mexico City) who are initiating tirzepatide under an independent clinical indication during the registry enrolment window, enrolled at or before Week 0 of tirzepatide exposure.
Protocol is identical to Cohort 1 from Week 0 forward; the difference is the absence of pre-tirzepatide retrospective reconstruction.
Expected n=10-20 recruited over 6-12 months.
Recruitment Status: Not yet recruiting.
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Dual GLP-1 and GIP receptor agonist administered subcutaneously at doses and intervals determined by the treating physician independently of this registry.
The registry does not supply, initiate, modify, or discontinue tirzepatide; exposure is documented from the medical record and patient report.
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Surgical Tissue Subcohort
Subset of enrolled Cohort 1 or Cohort 2 participants undergoing clinically indicated cardiac surgery at the Instituto Nacional de Cardiología Ignacio Chávez during follow-up (coronary artery bypass grafting, valve replacement, or combined procedures), providing additional informed consent for intraoperative collection of epicardial adipose tissue fragments routinely excised during cardiac access and discarded as surgical waste.
Tissue acquisition does not modify the surgical procedure.
This subcohort is declared at initial registration to establish scientific priority on direct human epicardial adipose tissue transcriptomic characterization under dual GIP/GLP-1 receptor agonism.
Operational launch requires (a) favorable opinion of INCar Comité de Investigación and Comité de Ética en Investigación for the tissue-specific protocol, (b) formal agreement with INCar Servicio de Cirugía Cardiovascular, (c) PRS amendment reflecting operational launch.
Recruitment Status: Not yet recruiting.
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Dual GLP-1 and GIP receptor agonist administered subcutaneously at doses and intervals determined by the treating physician independently of this registry.
The registry does not supply, initiate, modify, or discontinue tirzepatide; exposure is documented from the medical record and patient report.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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ACR20 response rate at Week 4 in the Mechanistic Analysis Set
Zeitfenster: week 4
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Proportion of patients in the Mechanistic Analysis Set (tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI <1.0 kg/m² through Week 4) achieving ACR20 response (American College of Rheumatology 20% improvement criteria) at Week 4, assessed by standardized clinical evaluation.
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week 4
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Proportion of Week-4 ACR20 response mediated by biomarker panel in the Mechanistic Analysis Set
Zeitfenster: Week 4
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Proportion of the Week-4 ACR20 response mediated by the combined biomarker panel (high-sensitivity C-reactive protein, SERPINB2, dipeptidyl peptidase-4 activity) in the Mechanistic Analysis Set, assessed by the MacKinnon product-of-coefficients method with 10,000 bias-corrected and accelerated (BCa) bootstrap iterations.
Decision thresholds are prespecified in the Statistical Analysis Plan.
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Week 4
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in knee cartilage T2 relaxation time from Week 0 to Week 52
Zeitfenster: Week 0 and week 52
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Change in femoro-tibial and patellar cartilage T2 relaxation time from Week 0 to Week 52, bilateral knees, stratified by zone (medial femur, lateral femur, medial tibia, lateral tibia, patella), analyzed at Ci3M UAM-Iztapalapa on Philips 3T platform.
Primary analysis: linear mixed-effects model with random intercepts for patient and for knee-within-patient.
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Week 0 and week 52
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Change in epicardial adipose tissue volume from Week 0 to Week 52
Zeitfenster: week 0 and week 52
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Change in epicardial adipose tissue (EAT) volume from Week 0 to Week 52 by non-contrast cardiac CT with prospective ECG gating at the Instituto Nacional de Cardiología Ignacio Chávez.
Primary analysis: linear mixed-effects model adjusted for baseline EAT volume, age, sex, and baseline BMI.
Unit of Measure: milliliters (mL)
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week 0 and week 52
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Change in epicardial adipose tissue mean attenuation from Week 0 to Week 52
Zeitfenster: week 0 and week 52
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Change in epicardial adipose tissue (EAT) mean attenuation from Week 0 to Week 52 on the same non-contrast cardiac CT acquisitions at the Instituto Nacional de Cardiología Ignacio Chávez.
Primary analysis: linear mixed-effects model adjusted for baseline EAT mean attenuation, age, sex, and baseline BMI.
Units of Measure: Hounsfield units (HU)
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week 0 and week 52
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Change in epicardial adipose tissue radiomic texture composite z-score from Week 0 to Week 52
Zeitfenster: week 0 and week 52
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Change in a prespecified compact radiomic signature derived from up to five IBSI-standardized texture features (first-order, GLCM, GLRLM, GLSZM, NGTDM families) computed on non-contrast cardiac CT EAT segmentations and expressed as a normalized composite z-score, from Week 0 to Week 52.
Primary analysis: linear mixed-effects model adjusted for baseline composite z-score, age, sex, and baseline BMI.
Units of Measure: z-score (dimensionless)
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week 0 and week 52
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Longitudinal visceral adipose tissue trajectory over six timepoints
Zeitfenster: week 0 through week 52
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Visceral adipose tissue (VAT) volume by seca multi-frequency bioelectrical impedance analysis at Week 0, 2, 4, 12, 24, and 52 at Universidad La Salle México.
Trajectory analyzed by linear mixed-effects model with random intercepts and slopes per patient.
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week 0 through week 52
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Longitudinal phase-angle trajectory (aging biomarker) over six timepoints
Zeitfenster: week 0 through week 52
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Bioimpedance phase angle (an established aging-biology biomarker) measured by seca mBCA at the six longitudinal timepoints.
Trajectory and slope modeled per patient and stratified by baseline age tercile.
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week 0 through week 52
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HLA-stratified articular and cardiac response
Zeitfenster: week 4 and week 52
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ACR20 response at Week 4 and EAT radiomic change at Week 52 stratified by HLA Class I and Class II allele-group profile (INCMNSZ Transplant Department PCR-SSO Reverse Luminex typing).
Hypothesis-generating.
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week 4 and week 52
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Change in Leeds Enthesitis Index (LEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup
Zeitfenster: week 0 and week 52
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Change in LEI score (range 0-6, one point per tender enthesis at six prespecified entheseal sites) from Week 0 to Week 52 in the subgroup with CASPAR-positive psoriatic arthritis.
Higher score indicates greater number of tender entheses.
Primary analysis: paired t-test or Wilcoxon signed-rank within subgroup.
Unit of Measure: score on a 0-6 scale (LEI)
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week 0 and week 52
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Change in Madrid Sonographic Enthesitis Index (MASEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup
Zeitfenster: week 0 and week 52
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Change in MASEI score (range 0-136, sonographic assessment of six bilateral entheseal sites for elementary lesions and complications) from Week 0 to Week 52 in the subgroup with CASPAR-positive psoriatic arthritis.
Higher score indicates greater sonographic enthesitis burden.
Primary analysis: paired t-test or Wilcoxon signed-rank within subgroup.
Unit of Measure: score on a 0-136 scale (MASEI)
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week 0 and week 52
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Transcriptomic signature of epicardial adipose tissue in tirzepatide-exposed participants undergoing cardiac surgery
Zeitfenster: At time of cardiac surgery, occurring within 36 months of enrolment
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Bulk and/or single-nucleus RNA sequencing of epicardial adipose tissue fragments collected intraoperatively during clinically indicated cardiac surgery (coronary artery bypass grafting, valve replacement, or combined procedures) at the Instituto Nacional de Cardiología Ignacio Chávez.
Differential gene expression and cell-type-resolved transcriptomic analysis compared between tirzepatide-exposed participants and matched non-exposed comparators.
Prespecified secondary analyses include correlation of tissue transcriptomic signature with radiomic EAT phenotype and HLA profile in the same participants.
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At time of cardiac surgery, occurring within 36 months of enrolment
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Longitudinal biomarker panel trajectories
Zeitfenster: week 0 through week 52
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Longitudinal trajectories of high-sensitivity C-reactive protein, SERPINB2, dipeptidyl peptidase-4 activity, and related incretin-axis biomarkers measured in banked serum aliquots at the six longitudinal timepoints.
Analyzed per patient and stratified by HLA profile.
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week 0 through week 52
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Change in modified Nail Psoriasis Severity Index (mNAPSI) from Week 0 to Week 52 in the psoriatic arthritis subgroup
Zeitfenster: Time Frame. Week 0 and Week 52.
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Change in dermoscopy-graded modified Nail Psoriasis Severity Index (mNAPSI; range 0-130 if all 20 nails assessed) from Week 0 to Week 52 in the subgroup with CASPAR-positive psoriatic arthritis. Higher score indicates greater nail involvement. Primary analysis: paired t-test or Wilcoxon signed-rank within subgroup. Unit of Measure. score on a mNAPSI scale. |
Time Frame. Week 0 and Week 52.
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Julio Granados-Montiel, MD, PhD, Universidad La Salle
- Hauptermittler: Erick Alexánderson-Rosas, MD, Instituto Nacional de Cardiologia Ignacio Chavez
- Hauptermittler: Marwin Gutierrez, MD, Centro de Enfermedades Reumaticas y Musculoesqueléticas
- Hauptermittler: Andres Moron, PhD, Metropolitan Autonomous University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Zwanenburg A, Vallieres M, Abdalah MA, Aerts HJWL, Andrearczyk V, Apte A, Ashrafinia S, Bakas S, Beukinga RJ, Boellaard R, Bogowicz M, Boldrini L, Buvat I, Cook GJR, Davatzikos C, Depeursinge A, Desseroit MC, Dinapoli N, Dinh CV, Echegaray S, El Naqa I, Fedorov AY, Gatta R, Gillies RJ, Goh V, Gotz M, Guckenberger M, Ha SM, Hatt M, Isensee F, Lambin P, Leger S, Leijenaar RTH, Lenkowicz J, Lippert F, Losnegard A, Maier-Hein KH, Morin O, Muller H, Napel S, Nioche C, Orlhac F, Pati S, Pfaehler EAG, Rahmim A, Rao AUK, Scherer J, Siddique MM, Sijtsema NM, Socarras Fernandez J, Spezi E, Steenbakkers RJHM, Tanadini-Lang S, Thorwarth D, Troost EGC, Upadhaya T, Valentini V, van Dijk LV, van Griethuysen J, van Velden FHP, Whybra P, Richter C, Lock S. The Image Biomarker Standardization Initiative: Standardized Quantitative Radiomics for High-Throughput Image-based Phenotyping. Radiology. 2020 May;295(2):328-338. doi: 10.1148/radiol.2020191145. Epub 2020 Mar 10.
- Granados-Montiel J, et al. SERPINB2 as a chondrogenic lineage marker. bioRxiv 2026. doi:10.64898/2026.03.29.713197
- Antonopoulos AS, Sanna F, Sabharwal N, Thomas S, Oikonomou EK, Herdman L, Margaritis M, Shirodaria C, Kampoli AM, Akoumianakis I, Petrou M, Sayeed R, Krasopoulos G, Psarros C, Ciccone P, Brophy CM, Digby J, Kelion A, Uberoi R, Anthony S, Alexopoulos N, Tousoulis D, Achenbach S, Neubauer S, Channon KM, Antoniades C. Detecting human coronary inflammation by imaging perivascular fat. Sci Transl Med. 2017 Jul 12;9(398):eaal2658. doi: 10.1126/scitranslmed.aal2658.
- Qin H, Yu J, Yu H, Zhou C, Yuan D, Wang Z, Zhu Z, Wei G, Ou P, Li Z, Jiang H, Shen J, Xiao G, Bai X, Wang H, Zhang HT, Speakman JR, Chen D, Tong L. Semaglutide ameliorates osteoarthritis progression through a weight loss-independent metabolic restoration mechanism. Cell Metab. 2026 Mar 3;38(3):582-597.e6. doi: 10.1016/j.cmet.2026.01.008. Epub 2026 Feb 9.
- Regmi A, Aihara E, Christe ME, Varga G, Beyer TP, Ruan X, Beebe E, O'Farrell LS, Bellinger MA, Austin AK, Lin Y, Hu H, Konkol DL, Wojnicki S, Holland AK, Friedrich JL, Brown RA, Estelle AS, Badger HS, Gaidosh GS, Kooijman S, Rensen PCN, Coskun T, Thomas MK, Roell W. Tirzepatide modulates the regulation of adipocyte nutrient metabolism through long-acting activation of the GIP receptor. Cell Metab. 2024 Jul 2;36(7):1534-1549.e7. doi: 10.1016/j.cmet.2024.05.010. Epub 2024 Jun 14.
- Merola JF, Mease P, Kivitz A, Sattar N, Coates LC, Aletaha D, Kartman CE, Fischer P, Sun L, Martinez-Osuna P, Kronbergs A, Prajapati P, Cardoso A, Genovese MC, Ogdie A. Ixekizumab With Tirzepatide Achieved Greater Disease Control Than Ixekizumab Alone in Adults With Psoriatic Arthritis and Overweight or Obesity: Results From a Randomized Clinical Trial. Arthritis Rheumatol. 2026 Mar 28. doi: 10.1002/art.70134. Online ahead of print.
- Packer M, Zile MR, Kramer CM, DiMaria JM, Baum SJ, Litwin SE, Murakami M, Zhou C, Ou Y, Koeneman L, Borlaug BA; SUMMIT Trial Study Group. Influence of Type 2 Diabetes on the Effects of Tirzepatide in Patients With Heart Failure and a Preserved Ejection Fraction With Obesity: A Prespecified Stratification-Based Analysis. J Am Coll Cardiol. 2025 Sep 9;86(10):696-707. doi: 10.1016/j.jacc.2025.06.058.
- Kramer CM, Borlaug BA, Zile MR, Ruff D, DiMaria JM, Menon V, Ou Y, Zarante AM, Hurt KC, Murakami M, Packer M; SUMMIT Trial Study Group. Tirzepatide Reduces LV Mass and Paracardiac Adipose Tissue in Obesity-Related Heart Failure: SUMMIT CMR Substudy. J Am Coll Cardiol. 2025 Feb 25;85(7):699-706. doi: 10.1016/j.jacc.2024.11.001. Epub 2024 Nov 18.
- Yu J, Hou M, Deng Y, Yu C, Liu Y, Kang K, Xia X, Li X, Yang H, Jiang D, Xu W, Zhang Y, Zhu X. Double-Pronged NAD Preservation: Delaying Cellular Senescence and Initiating Musculoskeletal Regeneration. Aging Cell. 2026 Apr;25(4):e70468. doi: 10.1111/acel.70468.
- Oikonomou EK, Marwan M, Desai MY, Mancio J, Alashi A, Hutt Centeno E, Thomas S, Herdman L, Kotanidis CP, Thomas KE, Griffin BP, Flamm SD, Antonopoulos AS, Shirodaria C, Sabharwal N, Deanfield J, Neubauer S, Hopewell JC, Channon KM, Achenbach S, Antoniades C. Non-invasive detection of coronary inflammation using computed tomography and prediction of residual cardiovascular risk (the CRISP CT study): a post-hoc analysis of prospective outcome data. Lancet. 2018 Sep 15;392(10151):929-939. doi: 10.1016/S0140-6736(18)31114-0. Epub 2018 Aug 28.
- Meyhofer SM, Cariou B, Cercato C, Colhoun HM, Deanfield J, Long MT, Jeppesen OK, Lincoff AM, Lingvay I, Plutzky J, Newsome PN, Nicholls SJ, Quiroga M, Santini F, Sanyal AJ, Kahn SE; SELECT Trial Investigators. Semaglutide on liver fibrosis and heart outcomes in patients at high risk of liver fibrosis: a prespecified analysis of the SELECT randomized trial. Nat Med. 2026 Apr 2. doi: 10.1038/s41591-026-04281-1. Online ahead of print.
- Nicholls SJ, Pavo I, Bhatt DL, Buse JB, Del Prato S, Kahn SE, Lincoff AM, McGuire DK, Miller D, Nauck MA, Nishiyama H, Nissen SE, Sattar N, Weerakkody G, Wiese RJ, Zinman B, Zoungas S, Basile J, Davies MJ, Giorgino F, Kellerer M, Ji L, Varkonyi T, Menon V, Broder JC, Herschtal A, D'Alessio D; SURPASS-CVOT Investigators. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. N Engl J Med. 2025 Dec 18;393(24):2409-2420. doi: 10.1056/NEJMoa2505928.
- Kang YM, Harrington J, Aroda VR, McGuire DK. Beyond GLP1: modulating multiple nutrient-stimulated hormone pathways to reduce cardiovascular risk. Nat Rev Cardiol. 2026 Apr 20. doi: 10.1038/s41569-026-01296-6. Online ahead of print. No abstract available.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Psoriasis-Arthritis
- ACR20
- Epikardiales Fettgewebe
- Viszerales Fettgewebe
- Tirzepatid
- HLA-Typisierung
- Bioelektrische Impedanzanalyse
- Phasenwinkel
- Mediationsanalyse
- Dual GIP/GLP-1 receptor agonist
- Multi-nutrient-stimulated hormones
- Inflammatory arthropathy
- Cartilage T2 mapping
- Quantitative knee MRI
- Cardiac CT radiomics
- Fat Attenuation Index
- seca mBCA
- Weight-independent effect
- Off-label exposure
- Mexican registry
- Epicardial adipose transcriptomics
- Single-nucleus RNA sequencing
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des endokrinen Systems
- Knochenerkrankungen
- Erkrankungen des Bewegungsapparates
- Erkrankungen des Nervensystems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Neuromuskuläre Manifestationen
- Pathologische Prozesse
- Ernährungsstörungen
- Pathologische Zustände, Anatomisch
- Herzkrankheiten
- Arthritis
- Gelenkerkrankungen
- Stoffwechselerkrankungen
- Überernährung
- Körpergewicht
- Arrhythmien, Herz
- Störungen des Glukosestoffwechsels
- Erkrankungen der Wirbelsäule
- Spondylarthropathien
- Hautkrankheiten, papulosquamös
- Hautkrankheiten
- Insulinresistenz
- Hyperinsulinismus
- Übergewicht
- Arteriosklerose
- Arterielle Verschlusskrankheiten
- Koronare Krankheit
- Myokardischämie
- Muskelatrophie
- Atrophie
- Spondylarthritis
- Spondylitis
- Schuppenflechte
- Pathologische Zustände, Anzeichen und Symptome
- Ernährungs- und Stoffwechselerkrankungen
- Haut- und Bindegewebserkrankungen
- Anzeichen und Symptome
- Herzfehler
- Fettleibigkeit
- Diabetes mellitus, Typ 2
- Metabolisches Syndrom
- Diabetes Mellitus
- Vorhofflimmern
- Koronare Herzkrankheit
- Sarkopenie
- Arthritis, Psoriasis
- Aminosäuren, Peptide und Proteine
- Proteine
- Glucagon-ähnliches Peptid-1-Rezeptor
- Glucagon-ähnliche Peptidrezeptoren
- Rezeptoren, G-Protein-gekoppelt
- Rezeptoren, Zelloberfläche
- Membranproteine
- Rezeptoren, Magen -Darm -Hormon
- Rezeptoren, Peptid
- Tirzepatid
Andere Studien-ID-Nummern
- CARTIZ-2026-001 (Andere Kennung: Universidad La Salle México)
- 64/019,134 (Andere Kennung: USPTO)
- 64/031,635 (Andere Kennung: USPTO)
- 64/039,918 (Andere Kennung: USPTO)
- 64/043,606 (Andere Kennung: USPTO)
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- STUDIENPROTOKOLL
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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