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Effects of Acetyl L-Carnitine Supplementation on Clinical, Metabolic and Inflammatory Symptoms in Obese, Diabetic, Postmenopausal Women With Osteoarthritis

14. september 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Pakistan
    • KPK
      • Bannu, KPK, Pakistan, 28100
        • Khalifa Gulnawaz Teaching Hospital, DHQ Teaching Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Age 55-65 years
  2. Duration of menopause 2-15 years.
  3. Duration of diabetes 5-15 years
  4. BMI Obese ≥30 kg/m2
  5. Grade≥2 K&L on radiologic examination

Exclusion Criteria:

  • Female patients with osteoarthritis meeting the following criteria will be excluded from the study;

    1. Age˂55 ˃65yrs
    2. Post-menopausal duration of ˂2yrs
    3. Duration of diabetes ˂ 5years
    4. 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
    5. Patients taking steroids (oral/ injections)
    6. Patients with a history of parathyroid and thyroid surgery/dysfunction

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Acetyl-l-carnitine
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.
Andre navn:
  • ALCAR, L-Carnitine (if used locally)
Placebo komparator: 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.
Legemiddel: Placebo
Matching placebo capsules administered orally twice daily for 12 weeks in addition to conventional osteoarthritis treatment.
Andre navn:
  • Placebo kapsler

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum C-Reactive Protein Concentration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Week 12
Change in serum ACTH concentration from baseline following 12 weeks of intervention
Baseline and Week 12
Serum Malondialdehyde (MDA) Concentration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Interleukin-6 (IL-6)
Tidsramme: Baseline and Week 12
Change in serum IL-6 concentration from baseline following 12 weeks of Acetyl L-Carnitine supplementation.
Baseline and Week 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Khyber Medical University Peshawar

Etterforskere

  • Hovedetterforsker: Dr Safia Bibi, PhD*, Khyber Medical University Peshawar, Pakistan
  • Hovedetterforsker: Dr Mohsin Shah, PhD, Khyber Medical University Peshawar, Pakistan
  • Hovedetterforsker: Dr Zia Ullah, PhD, Khalifa Gul Nawaz Teaching Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2025

Primær fullføring (Faktiske)

15. juli 2026

Studiet fullført (Faktiske)

15. august 2026

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KMU/DIR/CTU/2026/05

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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