{"id":"af038d7d-bc8d-5462-be34-f49c1c14f40d","stable_key":"e3f6ce02-0bd7-5103-acc1-68503ab6751b:dpn24-early-null","predicate":"no_detected_change_in_recorded_comparison","statement":"The 2024 trial did not find a significant between-group mTCNS change at 12 weeks.","claim_class":"observational","status":"source_recorded","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"3b7dd8fe-b92b-58a2-b6d4-142dba640cb6","mechanism_event_label":"The 2024 trial did not find a significant between-group mTCNS change at 12 weeks.","subject":{"id":"5ce394a9-6ec6-56dd-866f-37d85c0556e4","slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"},"object":{"id":"66c23e6e-9a55-568e-86e5-b9ac5da9335a","slug":"human-dpn-mtcns","display_name":"Human diabetic-neuropathy modified Toronto score","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"3b7dd8fe-b92b-58a2-b6d4-142dba640cb6","stable_key":"e3f6ce02-0bd7-5103-acc1-68503ab6751b:dpn24-early-null-event","event_type":"experimental_observation","label":"The 2024 trial did not find a significant between-group mTCNS change at 12 weeks.","description":"### dpn24-early-null\n\nThe 2024 trial did not find a significant between-group mTCNS change at 12 weeks.\nThe later significant composite endpoint must not be back-projected to the earlier assessment.\nModel and exposure: Same randomized trial; 12-week change −5.0 versus −4.3, P=0.120.\nLimitations: Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.\nReference: Acetyllevocarnitine Hydrochloride for the Treatment of Diabetic Peripheral Neuropathy: A Phase 3 Randomized Clinical Trial in China. | 2024 | https://pubmed.ncbi.nlm.nih.gov/38320260/ | https://pmc.ncbi.nlm.nih.gov/articles/PMC11043058/ | https://doi.org/10.2337/db23-0377 | Access: Primary full text: relevant Results/Methods and figure descriptions reviewed; supplements only where explicitly stated.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"5ce394a9-6ec6-56dd-866f-37d85c0556e4","slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"},"role":"tested factor","stoichiometry":null,"state_label":"ALCAR hydrochloride through 12 weeks","sequence_order":0,"notes":""},{"entity":{"id":"66c23e6e-9a55-568e-86e5-b9ac5da9335a","slug":"human-dpn-mtcns","display_name":"Human diabetic-neuropathy modified Toronto score","entity_type_key":"cellular_process"},"role":"measured outcome","stoichiometry":null,"state_label":"no_detected_change","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_access","value_text":"Primary full text: relevant Results/Methods and figure descriptions reviewed; supplements only where explicitly stated.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_contrast","value_text":"{\"intervention\": \"ALCAR hydrochloride through 12 weeks\", \"comparator\": \"Placebo\", \"endpoint\": \"The 2024 trial did not find a significant between-group mTCNS change at 12 weeks.\", \"effect_direction\": \"no_detected_change\", \"combination\": \"single\", \"conditions\": []}","comparator":null,"unit":null,"notes":"Explicit extracted experimental comparison; source-derived draft.","entity":null},{"dimension":"experimental_model","value_text":"Same randomized trial; 12-week change −5.0 versus −4.3, P=0.120.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"interpretation_status","value_text":"Source-derived curation with stated access limits; ungraded, not independent replication.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Acetyl-L-carnitine collection; exact intervention and molecular form govern interpretation.","comparator":null,"unit":null,"notes":"","entity":{"slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"}},{"dimension":"plain_language","value_text":"The 2024 trial did not find a significant between-group mTCNS change at 12 weeks.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"Acetyllevocarnitine Hydrochloride for the Treatment of Diabetic Peripheral Neuropathy: A Phase 3 Randomized Clinical Trial in China. | https://pubmed.ncbi.nlm.nih.gov/38320260/ | https://pmc.ncbi.nlm.nih.gov/articles/PMC11043058/ | https://doi.org/10.2337/db23-0377","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"source_locator","value_text":"Reviewed reference dpn24-early-null; The later significant composite endpoint must not be back-projected to the earlier assessment.","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"1d5940ea-8a1b-5fdd-98fe-99d7a1b15171","evidence_kind":"source_excerpt","locator":"Lines 515-521","start_line":515,"end_line":521,"excerpt":"### dpn24-early-null\n\nThe 2024 trial did not find a significant between-group mTCNS change at 12 weeks.\nThe later significant composite endpoint must not be back-projected to the earlier assessment.\nModel and exposure: Same randomized trial; 12-week change −5.0 versus −4.3, P=0.120.\nLimitations: Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.\nReference: Acetyllevocarnitine Hydrochloride for the Treatment of Diabetic Peripheral Neuropathy: A Phase 3 Randomized Clinical Trial in China. | 2024 | https://pubmed.ncbi.nlm.nih.gov/38320260/ | https://pmc.ncbi.nlm.nih.gov/articles/PMC11043058/ | https://doi.org/10.2337/db23-0377 | Access: Primary full text: relevant Results/Methods and figure descriptions reviewed; supplements only where explicitly stated.","model_system":"Same randomized trial; 12-week change −5.0 versus −4.3, P=0.120.","directness":"reported_statement","verification_status":"source_recorded","notes":"Original paraphrase in the retained reviewed reference, not a verbatim primary-paper quotation. Access level is explicit.","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"2588f904-245a-597a-8a12-65118013fb90","stable_key":"import-e3f6ce02-0bd7-5103-acc1-68503ab6751b","title":"Acetyl-L-carnitine: detailed mechanisms of action (reviewed 6 October 2026)","document_type":"imported_text","citation_label":"AI-assisted original review of primary studies and clearly identified official records. Exact primary access is stated; no independent replication is claimed.","file_path":"","sha256":"84cc82d6fbb0fd5d73c4ce779e9f88e7f0184ba2d29b18ad0f153815380f2975","revision_id":"dac7a950-dbe5-5c7a-9c70-2ea711d5c71a","review_status":"source_recorded","notes":""}}],"relations":[],"conflicts":[],"corrections":[],"research":null}