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NCT Number: NCT07660081

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetyl-L-carnitine

Drug

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.

Other names: ALCAR, L-Carnitine (if used locally)

Placebo

Drug

Matching placebo capsules administered orally twice daily for 12 weeks in addition to conventional osteoarthritis treatment.

Other names: Placebo capsules

Primary outcomes

  1. Change in C-Reactive Protein (CRP)

    Time frame: Baseline and Week 12

    Change in serum CRP concentration from baseline following 12 weeks of Acetyl L-Carnitine supplementation.

  2. Change in Fasting Blood Glucose

    Time frame: Baseline and Week 12

    Change in fasting blood glucose levels from baseline following 12 weeks of intervention.

  3. Change in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline and Week 12

    Change in HbA1c levels from baseline following 12 weeks of intervention.

  4. Change in Insulin Resistance (HOMA-IR)

    Time frame: Baseline and Week 12

    Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline following 12 weeks of intervention.

  5. Change in Serum Insulin

    Time frame: Baseline and Week 12

    Change in fasting serum insulin concentration from baseline following 12 weeks of intervention.

  6. Change in Serum Leptin

    Time frame: Baseline and Week 12

    Change in serum leptin concentration from baseline following 12 weeks of intervention.

  7. Change in Serum Adiponectin

    Time frame: Baseline and Week 12

    Change in serum adiponectin concentration from baseline following 12 weeks of intervention.

  8. Change in Adrenocorticotropic Hormone (ACTH)

    Time frame: Baseline and Week 12

    Change in serum ACTH concentration from baseline following 12 weeks of intervention

  9. Change in Malondialdehyde (MDA)

    Time frame: Baseline and Week 12

    Change in serum malondialdehyde levels as a marker of oxidative stress from baseline following 12 weeks of intervention.

  10. Change in Advanced Glycation End Products (AGEs)

    Time frame: Baseline and Week 12

    Change in serum AGEs levels from baseline following 12 weeks of intervention.

  11. Change in WOMAC Osteoarthritis Score

    Time frame: Baseline and Week 12

    Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline following 12 weeks of intervention.

  12. Change in Kellgren-Lawrence Radiographic Grade

    Time frame: Baseline and Week 12

    Change in osteoarthritis radiographic severity assessed by the Kellgren-Lawrence grading system from baseline following 12 weeks of intervention.

Secondary outcomes

  1. Change in Interleukin-6 (IL-6)

    Time frame: Baseline and Week 12

    Change in serum IL-6 concentration from baseline following 12 weeks of Acetyl L-Carnitine supplementation.

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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