Effects of Acetyl L-Carnitine Supplementation on Clinical, Metabolic and Inflammatory Symptoms in Obese, Diabetic, Postmenopausal Women With Osteoarthritis
14 de septiembre de 2026 actualizado por: Khyber Medical University Peshawar
Effects of Acetyl L-Carnitine Supplementation on Clinical, Metabolic and Inflammatory Symptoms in Obese, Diabetic, Postmenopausal Women With Osteoarthritis: Randomized Controlled Trial
OA is a degenerative bone disease more common in postmenopausal women.
Diabetes and obesity are common risk factors for the development of OA.
The common symptoms include pain and disability of the affected joint, leading to mobility issues.
Acetyl L-carnitine due to its known anti-inflammatory, chondroprotective, and improved insulin-sensitizing effects may help in alleviating the symptoms and progression of OA in obese diabetic postmenopausal women.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Osteoarthritis (OA) is a chronic degenerative joint disease that commonly affects older adults and is associated with pain, stiffness, reduced mobility, and disability. The coexistence of obesity and type 2 diabetes mellitus may aggravate the progression and severity of OA through metabolic dysfunction, chronic low-grade inflammation, oxidative stress, and altered adipokine profiles. Postmenopausal women are particularly vulnerable because hormonal changes contribute to increased inflammation, obesity, insulin resistance, and joint degeneration.
Acetyl L-Carnitine is a naturally occurring compound involved in mitochondrial energy metabolism. Previous studies have demonstrated anti-inflammatory, antioxidant, and metabolic benefits of Acetyl L-Carnitine, including improvements in insulin resistance, lipid metabolism, oxidative stress, and inflammatory cytokine production. Experimental studies have also suggested chondroprotective effects through enhancement of cartilage matrix synthesis and mitochondrial function.
This double-blind, placebo-controlled randomized clinical trial will enroll 100 obese, diabetic, postmenopausal women with radiologically confirmed osteoarthritis. Participants will be randomly assigned to receive either Acetyl L-Carnitine (1.5 g twice daily) or placebo for 12 weeks in addition to conventional osteoarthritis treatment.
Clinical outcomes will include assessment of osteoarthritis symptoms using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), radiological severity using the Kellgren-Lawrence grading system, perceived stress, and depression, anxiety and stress scores. Laboratory outcomes will include glycemic profile, lipid profile, insulin resistance markers, inflammatory biomarkers (CRP and IL-6), oxidative stress markers, adipokines, stress hormones, and complete blood count parameters.
The study seeks to determine whether Acetyl L-Carnitine supplementation can improve clinical, metabolic, inflammatory, and radiological outcomes in obese, diabetic, postmenopausal women with osteoarthritis.
Tipo de estudio
Intervencionista
Inscripción (Actual)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
KPK
-
Bannu, KPK, Pakistán, 28100
- Khalifa Gulnawaz Teaching Hospital, DHQ Teaching Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Age 55-65 years
- Duration of menopause 2-15 years.
- Duration of diabetes 5-15 years
- BMI Obese ≥30 kg/m2
- Grade≥2 K&L on radiologic examination
Exclusion Criteria:
Female patients with osteoarthritis meeting the following criteria will be excluded from the study;
- Age˂55 ˃65yrs
- Post-menopausal duration of ˂2yrs
- Duration of diabetes ˂ 5years
- Patients with alcohol abuse, asthma, cardiac disease, chronic gastric problems (malabsorption, crohn's disease chronic diarrhea), non-diabetes related renal disease,ovariectomy, rheumatoid arthritis or other rheumatic inflammatory diseases, smoking
- Patients taking steroids (oral/ injections)
- Patients with a history of parathyroid and thyroid surgery/dysfunction
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Acetyl L-Carnitine Group
Participants will receive conventional treatment for osteoarthritis, including NSAIDs, COX-2 inhibitors, or acetaminophen as prescribed, together with Acetyl L-Carnitine capsules 1.5 g orally twice daily (total daily dose 3 g) after meals for 12 weeks.
Participants will continue their usual oral antihyperglycemic medications but will not receive insulin.
|
Acetyl L-Carnitine capsules, 1.5 g administered orally twice daily (total daily dose 3 g) after meals for 12 weeks in addition to conventional osteoarthritis treatment.
Otros nombres:
|
|
Comparador de placebos: Placebo Control Group
Participants will receive matching placebo capsules administered orally at a dose of two capsules daily after meals for 12 weeks, in addition to conventional osteoarthritis treatment, including NSAIDs, COX-2 inhibitors, or acetaminophen as prescribed.
|
Matching placebo capsules administered orally twice daily for 12 weeks in addition to conventional osteoarthritis treatment.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serum C-Reactive Protein Concentration
Periodo de tiempo: Baseline and Week 12
|
Change in Serum C-Reactive Protein (CRP) Concentration (mg/L) from baseline following 12 weeks of Acetyl L-Carnitine supplementation.
|
Baseline and Week 12
|
|
Fasting Blood Glucose Concentration
Periodo de tiempo: Baseline and Week 12
|
Change in fasting blood glucose levels (mg/dL) from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
|
Glycated Hemoglobin (HbA1c) Percentage
Periodo de tiempo: Baseline and Week 12
|
Change in HbA1c levels (%) from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Periodo de tiempo: Baseline and Week 12
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
|
Fasting Serum Insulin Concentration
Periodo de tiempo: Baseline and Week 12
|
Change in fasting serum insulin concentration (µIU/mL) from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
|
Serum Leptin Concentration
Periodo de tiempo: Baseline and Week 12
|
Change in serum leptin concentration (ng/mL) from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
|
Serum Adiponectin Concentration
Periodo de tiempo: Baseline and Week 12
|
Change in serum adiponectin concentration (µg/mL) from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
|
Serum Adrenocorticotropic Hormone (ACTH) Concentration
Periodo de tiempo: Baseline and Week 12
|
Change in serum ACTH concentration from baseline following 12 weeks of intervention
|
Baseline and Week 12
|
|
Serum Malondialdehyde (MDA) Concentration
Periodo de tiempo: Baseline and Week 12
|
Change in serum malondialdehyde levels as a marker of oxidative stress from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
|
Serum Advanced Glycation End Products (AGEs) Concentration
Periodo de tiempo: Baseline and Week 12
|
Change in serum AGEs levels from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
|
WOMAC Osteoarthritis Index total Score
Periodo de tiempo: Baseline and Week 12
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
|
Kellgren-Lawrence Radiographic Grade
Periodo de tiempo: Baseline and Week 12
|
Change in osteoarthritis radiographic severity assessed by the Kellgren-Lawrence grading system from baseline following 12 weeks of intervention.
|
Baseline and Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Interleukin-6 (IL-6)
Periodo de tiempo: Baseline and Week 12
|
Change in serum IL-6 concentration from baseline following 12 weeks of Acetyl L-Carnitine supplementation.
|
Baseline and Week 12
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Dr Safia Bibi, PhD*, Khyber Medical University Peshawar, Pakistan
- Investigador principal: Dr Mohsin Shah, PhD, Khyber Medical University Peshawar, Pakistan
- Investigador principal: Dr Zia Ullah, PhD, Khalifa Gul Nawaz Teaching Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Prieto-Alhambra D, Judge A, Javaid MK, Cooper C, Diez-Perez A, Arden NK. Incidence and risk factors for clinically diagnosed knee, hip and hand osteoarthritis: influences of age, gender and osteoarthritis affecting other joints. Ann Rheum Dis. 2014 Sep;73(9):1659-64. doi: 10.1136/annrheumdis-2013-203355. Epub 2013 Jun 6.
- GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.
- Thijssen E, van Caam A, van der Kraan PM. Obesity and osteoarthritis, more than just wear and tear: pivotal roles for inflamed adipose tissue and dyslipidaemia in obesity-induced osteoarthritis. Rheumatology (Oxford). 2015 Apr;54(4):588-600. doi: 10.1093/rheumatology/keu464. Epub 2014 Dec 11.
- Francisco V, Tovar S, Conde J, Pino J, Mera A, Lago F, Gonzalez-Gay MA, Dieguez C, Gualillo O. Levels of the Novel Endogenous Antagonist of Ghrelin Receptor, Liver-Enriched Antimicrobial Peptide-2, in Patients with Rheumatoid Arthritis. Nutrients. 2020 Apr 6;12(4):1006. doi: 10.3390/nu12041006.
- Lu Q, Zhang Y, Elisseeff JH. Carnitine and acetylcarnitine modulate mesenchymal differentiation of adult stem cells. J Tissue Eng Regen Med. 2015 Dec;9(12):1352-62. doi: 10.1002/term.1747. Epub 2013 Apr 29.
- Walker C, Faustino A, Lanas A. Monitoring complete blood counts and haemoglobin levels in osteoarthritis patients: results from a European survey investigating primary care physician behaviours and understanding. Open Rheumatol J. 2014 Dec 19;8:110-5. doi: 10.2174/1874312901408010110. eCollection 2014.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de diciembre de 2025
Finalización primaria (Actual)
15 de julio de 2026
Finalización del estudio (Actual)
15 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
16 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de junio de 2026
Publicado por primera vez (Actual)
22 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades musculoesqueléticas
- Trastornos Nutricionales
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Diabetes Mellitus, Tipo 2
- Osteoartritis
- Químicos orgánicos
- Amina
- Compuestos de amonio cuaternario
- Compuestos de trimetil amonio
- Acetilcarnitina
- Carnitina
Otros números de identificación del estudio
- KMU/DIR/CTU/2026/05
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data underlying the results reported in publications arising from this study will be made available to qualified researchers upon reasonable request.
Shared data may include demographic characteristics, clinical outcomes, biochemical measurements, inflammatory markers, hormonal markers, and questionnaire data collected during the study.
All data will be de-identified before sharing to protect participant confidentiality.
Marco de tiempo para compartir IPD
Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
Criterios de acceso compartido de IPD
Researchers who provide a methodologically sound research proposal may request access to de-identified participant data.
Requests will be reviewed by the principal investigator.
Data will be shared following approval of the proposal and execution of an appropriate data-sharing agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .