- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07617402
Exploring the Brain - Gut Microbiota - Kidney Interactive Damage Mechanisms Underlying Cognitive Decline in Patients With IgA Nephropathy Using Ultra-high Field Magnetic Resonance Imaging
Brain-Gut-Kidney Axis in IgA Nephropathy Cognitive Decline: An Ultra-High Field MRI Study
IgA nephropathy (IgAN) is the most common primary glomerular disease worldwide. Its progression is often accompanied by cognitive decline, manifesting as multi-dimensional cognitive deficits in areas such as memory, attention, and executive function. Cognitive decline in patients with IgAN severely impacts their quality of life, yet the underlying central nervous system (CNS) damage mechanisms remain unclear, and no effective interventions are currently available. Recent domestic and international studies suggest a potential interactive damage network involving the brain, gut microbiota, and kidneys in patients with chronic kidney disease (CKD). Therefore, exploring the causes of cognitive decline in IgAN patients from the perspective of multi-organ interactive damage, identifying brain injury targets and aberrant gut microbial communities that correlate with changes in renal function, is crucial for the development of effective and precise clinical interventions.
Our team has been conducting MRI research on brain injury associated with cognitive decline in CKD since 2015. We have extensive experience in studying brain structure, function, metabolism, and perfusion in patients with end-stage renal disease (ESRD). Our work has been supported by numerous grants, including the General Program and Young Scientists Fund of the National Natural Science Foundation of China (NSFC) and the Key R&D Program of Shaanxi Province, yielding a series of scientific achievements. The etiological heterogeneity and high prevalence of IgAN suggest that we should focus on the central mechanisms of cognitive decline in this specific patient population. The recent clinical application of 7.0 Tesla (T) ultra-high field MRI provides critical hardware support, enabling us to investigate sub-millimeter-level structural and functional abnormalities in the early stages of IgAN.
This study aims to recruit 100 patients with IgAN from the Department of Nephrology and 100 demographically matched healthy controls from the local community. We will collect serum, stool samples, and brain ultra-high field MRI data from both patients and controls. By integrating these data with assessments from multi-dimensional neurocognitive scales, we will explore the potential brain-gut-kidney damage characteristics underlying cognitive decline in IgAN patients from the perspectives of serum metabolomics, fecal gut microbiota analysis, and multi-modal ultra-high field brain MRI analysis.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Xi'an
-
Shanxi, Xi'an, Čína, 713800
- Functional and Molecular Imaging Key Lab of Shaanxi Province, Department of Radiology, Tangdu Hospital, Fourth Military Medical University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
IgA Nephropathy (IgAN) Group: A cohort of 100 patients diagnosed with IgA nephropathy, confirmed by pathological biopsy.
Healthy Control (HC) Group: A cohort of 100 healthy volunteers who are demographically matched to the patient group in terms of age, gender, and educational attainment.
Popis
Inclusion Criteria:
- Right-handed individuals, age 18-60 years;
- Diagnosis of IgA nephropathy confirmed by renal biopsy.
Exclusion Criteria:
- Secondary IgA nephropathy, such as that associated with systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, hepatitis B or C infection, or drug-induced causes.
- History of kidney transplantation, hemodialysis, or peritoneal dialysis.
- Acute cerebrovascular event within the past 3 months; a history of severe traumatic brain injury, brain tumor, stroke, or encephalomalacia that has resulted in identifiable lesions or significant asymmetry of cranial anatomy.
- Malignant tumors; a history of intestinal surgery; or irritable bowel syndrome (IBS).
- Use of antibiotics, steroids, immunosuppressants, or microbiota-based preparations within the past month.
- Inflammatory bowel disease (IBD); or the presence of symptoms such as diarrhea, abdominal pain, or IBS-like symptoms within the past two weeks.
- History of alcohol dependence.
- Current use of psychiatric medications, such as antidepressants or anxiolytics.
- Loss of hearing or vision.
- Pregnancy or lactation.
- Current participation in another clinical trial.
Contraindications for 7.0T MRI Presence of ferromagnetic implants in the body (e.g., cardiac pacemakers, defibrillators, neurostimulators, aneurysm clips, cochlear implants, or any other metallic foreign bodies).
Non-ferromagnetic implants (e.g., titanium alloy, orthopedic implants), intrauterine devices (IUDs), or non-removable dental prosthetics (including dental implants).
Metallic foreign bodies in the eye or body (e.g., metal fragments, shrapnel, or metallic debris), such as in individuals with a history of welding or metal-related injuries.
Tattoos or permanent makeup (e.g., on eyebrows or lips) acquired within the last month.
Claustrophobia. Fever. Inclusion Criteria for the Healthy Control Group
All healthy controls must meet the following criteria:
- Right-handed, aged 18-60 years;
- All physiological indicators within the normal range, with no signs of disease;
- No family history of psychiatric or neurological disorders.
Exclusion Criteria for the Healthy Control Group
- History of cranial surgery, brain tumor, traumatic brain injury, stroke, or encephalomalacia resulting in significant asymmetry of cranial anatomy;
- History of psychiatric disorders, alcohol dependence, or central nervous system diseases;
- Presence of metallic foreign bodies in the body or claustrophobia, making them unsuitable for MRI scanning;
- History of hypertension, diabetes, or hyperlipidemia;
- Hearing or vision impairment that would affect communication during the MRI scan or the completion of cognitive assessments.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
HC
|
|
IgAN
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Gut Microbiome Metagenomic Characteristics
Časové okno: April 2025 to March 2027
|
Description: Taxonomic composition, relative abundance of microbial taxa, alpha diversity indices (Shannon, Simpson), and functional pathway profiles derived from shotgun metagenomic sequencing of fecal samples. Unit/Scale: Relative abundance (%), Shannon index, Simpson index, normalized pathway abundance. |
April 2025 to March 2027
|
|
Functional Neuroimaging Indices
Časové okno: April 2025 to March 2027
|
Description: Resting-state functional magnetic resonance imaging (rs-fMRI) derived metrics, including functional connectivity (FC), amplitude of low-frequency fluctuation (ALFF), fractional ALFF (fALFF), and regional homogeneity (ReHo). Unit/Scale: Standardized Z-scores, correlation coefficients. |
April 2025 to March 2027
|
|
Cognitive Function Scores
Časové okno: April 2025 to March 2027
|
Description: Cognitive performance assessed using the Montreal Cognitive Assessment (MoCA). Scale/Range: 0-30 points. Interpretation: Higher scores indicate better cognitive function; lower scores indicate more severe cognitive impairment. |
April 2025 to March 2027
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Serum Metabolomic and Biomarker Levels
Časové okno: April 2025 to March 2027
|
Description: Quantitative analysis of serum metabolomic profiles, inflammatory factors (e.g., IL-6, TNF-α), and neurotransmitters (e.g., serotonin, dopamine) using targeted metabolomics assays. Unit/Scale: pg/mL, ng/mL, or standardized relative concentration units. |
April 2025 to March 2027
|
|
Fecal Gut Microbiome Analysis
Časové okno: April 2025 to March 2027
|
Description: Taxonomic composition, alpha/beta diversity, and differential microbial taxa identified via 16S rRNA gene sequencing or shotgun metagenomic sequencing of fecal samples. Unit/Scale: Relative abundance (%), Shannon index, Simpson index, Bray-Curtis dissimilarity. |
April 2025 to March 2027
|
|
Memory Function (Cognitive Subdomain)
Časové okno: April 2025 to March 2027
|
Description: Verbal memory assessed using the Auditory Verbal Learning Test (AVLT). Scale/Range: 0-75 points (AVLT total recall score). Interpretation: Higher scores indicate better memory performance. |
April 2025 to March 2027
|
|
Attention and Executive Function (Cognitive Subdomains)
Časové okno: April 2025 to March 2027
|
Description: Attention and executive function assessed using the Stroop Color-Word Test and Trail Making Test (TMT). Unit/Scale: Reaction time (seconds), completion time (seconds), number of errors. Interpretation: Shorter completion time and fewer errors indicate better attention and executive function. |
April 2025 to March 2027
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- K202508-23
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na IgA nefropatie (IgAN)
-
Zhi-Hong Liu, M.D.Dokončeno
-
Nanfang Hospital, Southern Medical UniversityZatím nenabíráme
-
Keda LuRed Cross Hospital, Hangzhou, China; Shanghai 6th People's Hospital; The First... a další spolupracovníciZatím nenabírámeIgA nefropatie (IgAN)
-
ADARx Pharmaceuticals, Inc.NáborIgAN | C3G | IC-MPGN | IgA nefropatie (IgAN) | Onemocnění ledvin zprostředkované doplňkemSpojené státy, Austrálie, Hongkong, Jižní Korea, Španělsko, Spojené království
-
Haisco Pharmaceutical Group Co., Ltd.NáborA Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA NephropathyIgA nefropatie (IgAN)Čína
-
Linno Pharmaceuticals, Inc.Zatím nenabíráme
-
Haisco Pharmaceutical Group Co., Ltd.NáborIgA nefropatie (IgAN)Čína
-
Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics...NáborIgA nefropatie (IgAN)Čína
-
Arbor Research Collaborative for HealthDokončeno
-
Waid City Hospital, ZurichZatím nenabírámeIgA nefropatie (IgAN)Švýcarsko