DUAL-REGISTERED PROTOCOL // OSF PRE-REGISTERED (DOI: 10.17605/OSF.IO/VPS9D) · CLINICALTRIALS.GOV PRS IN PROGRESS · PROTOCOL ID: DS-CLIN-2026-METABO-RESOLVE · PLANNED N = 10,000
METABO-RESOLVE™ Registry.
Deciphering the mitochondrial & metabolic web.
Inborn errors of metabolism and primary mitochondrial cytopathies are among the most difficult diseases in medicine. METABO-RESOLVE™ is a global, prospective decentralized clinical registry ($N=10,000$) uniting multi-system metabolomics, acylcarnitine tensors, and respiratory chain kinetics under the DeepSensi Cognitive Engine. Participation in the clinical registry is 100% Free.
RESOLVE in the United States: in preparation (IRB submission in preparation, the first country to open).
Registry Strata
Three Core Metabolic Pathology Cohorts
Mitochondrial Cytopathies & Leigh Syndrome
MELAS, MERRF, Kearns-Sayre, and Leigh Syndrome with primary complex I-V respiratory chain deficits. High-dimensional mapping of lactate/pyruvate ratios, alanine flux, and CoQ10 transport dynamics under DSS-001.
Organic Acidemias & Urea Cycle Defects
Methylmalonic Acidemia (MMA), Propionic Acidemia (PA), Isovaleric Acidemia (IVA), and partial urea cycle defects. Serial quantification of methylmalonate, orotic acid, plasma ammonia risk tensors, and secondary carnitine depletion.
Fatty Acid Oxidation Disorders (FAOD)
Medium-chain (MCAD), very long-chain (VLCAD), and LCHAD acyl-CoA dehydrogenase deficiencies. Tracking plasma acylcarnitine species (C0-C18), hypoketotic hypoglycemia triggers, and rhabdomyolysis biomarkers.
From routine care, ordered by each participant's own physicians, the registry also records urine organic acids.
Biomarkers & Outcomes
Multi-System Metabolomic & Clinical Endpoints
Plasma Acylcarnitines & Amino Acids
Serial quantitative tandem mass spectrometry profiling free carnitine, C2-C18 esters, and quantitative plasma amino acids (glutamine, alanine, citrulline, arginine, BCAAs).
Mitochondrial Bioenergetics & OAT
75+ quantitative organic acids: lactic, pyruvic, 2-ketoglutaric, succinic, fumaric, and malic acids, paired with total anion gap calculation and blood gas correlations under DSS-001.
Reduction in Metabolic Decompensation
Significant decrease in emergency department visits, acute metabolic acidosis crises, hyperammonemic episodes, and ICU admissions under physician-approved metabolic co-signatures.
DeepSensi DCT
