{"id":"fd648f33-b050-581b-a473-3aed49029c2e","stable_key":"e3f6ce02-0bd7-5103-acc1-68503ab6751b:dpn05-biopsy","predicate":"increases_in_recorded_comparison","statement":"ALCAR improved reported sural fiber-number and regenerating-cluster measurements in pooled diabetic-neuropathy trials.","claim_class":"observational","status":"source_recorded","evidence_grade":"ungraded","direction":"positive","is_public":true,"mechanism_event_id":"72e28f39-ceac-5556-9a77-98cea992a842","mechanism_event_label":"ALCAR improved reported sural fiber-number and regenerating-cluster measurements in pooled diabetic-neuropathy trials.","subject":{"id":"5ce394a9-6ec6-56dd-866f-37d85c0556e4","slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"},"object":{"id":"7b40784c-29c1-51cc-b708-bdfbcbf8565a","slug":"human-dpn-sural-morphometry","display_name":"Human diabetic-neuropathy sural nerve morphometry","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"72e28f39-ceac-5556-9a77-98cea992a842","stable_key":"e3f6ce02-0bd7-5103-acc1-68503ab6751b:dpn05-biopsy-event","event_type":"experimental_observation","label":"ALCAR improved reported sural fiber-number and regenerating-cluster measurements in pooled diabetic-neuropathy trials.","description":"### dpn05-biopsy\n\nALCAR improved reported sural fiber-number and regenerating-cluster measurements in pooled diabetic-neuropathy trials.\nTwo 52-week trials, 1,257 intention-to-treat patients; 500 or 1,000 mg three times daily. Morphometry is not an ulcer/amputation endpoint.\nModel and exposure: Two 52-week placebo-controlled trials; 1,257 ITT patients; 500 or 1,000 mg three times daily.\nLimitations: Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.\nReference: Acetyl-L-carnitine improves pain, nerve regeneration, and vibratory perception in patients with chronic diabetic neuropathy: an analysis of two randomized placebo-controlled trials. | 2005 | https://pubmed.ncbi.nlm.nih.gov/15616239/ | https://doi.org/10.2337/diacare.28.1.89 | Access: Indexed primary abstract/metadata only; unextracted doses, figures and methods remain unknown.","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 regimen","sequence_order":0,"notes":""},{"entity":{"id":"7b40784c-29c1-51cc-b708-bdfbcbf8565a","slug":"human-dpn-sural-morphometry","display_name":"Human diabetic-neuropathy sural nerve morphometry","entity_type_key":"cellular_process"},"role":"measured outcome","stoichiometry":null,"state_label":"increase","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_access","value_text":"Indexed primary abstract/metadata only; unextracted doses, figures and methods remain unknown.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_contrast","value_text":"{\"intervention\": \"ALCAR regimen\", \"comparator\": \"Placebo\", \"endpoint\": \"ALCAR improved reported sural fiber-number and regenerating-cluster measurements in pooled diabetic-neuropathy trials.\", \"effect_direction\": \"increase\", \"combination\": \"single\", \"conditions\": []}","comparator":null,"unit":null,"notes":"Explicit extracted experimental comparison; source-derived draft.","entity":null},{"dimension":"experimental_model","value_text":"Two 52-week placebo-controlled trials; 1,257 ITT patients; 500 or 1,000 mg three times daily.","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":"ALCAR improved reported sural fiber-number and regenerating-cluster measurements in pooled diabetic-neuropathy trials.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"Acetyl-L-carnitine improves pain, nerve regeneration, and vibratory perception in patients with chronic diabetic neuropathy: an analysis of two randomized placebo-controlled trials. | https://pubmed.ncbi.nlm.nih.gov/15616239/ | https://doi.org/10.2337/diacare.28.1.89","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"source_locator","value_text":"Reviewed reference dpn05-biopsy; Two 52-week trials, 1,257 intention-to-treat patients; 500 or 1,000 mg three times daily. Morphometry is not an ulcer/amputation endpoint.","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"41b95163-8998-57ed-bd4a-c619fefa6f6f","evidence_kind":"source_excerpt","locator":"Lines 475-481","start_line":475,"end_line":481,"excerpt":"### dpn05-biopsy\n\nALCAR improved reported sural fiber-number and regenerating-cluster measurements in pooled diabetic-neuropathy trials.\nTwo 52-week trials, 1,257 intention-to-treat patients; 500 or 1,000 mg three times daily. Morphometry is not an ulcer/amputation endpoint.\nModel and exposure: Two 52-week placebo-controlled trials; 1,257 ITT patients; 500 or 1,000 mg three times daily.\nLimitations: Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.\nReference: Acetyl-L-carnitine improves pain, nerve regeneration, and vibratory perception in patients with chronic diabetic neuropathy: an analysis of two randomized placebo-controlled trials. | 2005 | https://pubmed.ncbi.nlm.nih.gov/15616239/ | https://doi.org/10.2337/diacare.28.1.89 | Access: Indexed primary abstract/metadata only; unextracted doses, figures and methods remain unknown.","model_system":"Two 52-week placebo-controlled trials; 1,257 ITT patients; 500 or 1,000 mg three times daily.","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}