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.

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.

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

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.

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

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.

This is a double-blind placebo-controlled trial. Participants will receive either Acetyl L-Carnitine or placebo. Investigators, healthcare providers, participants, and outcome assessors will remain unaware of treatment allocation throughout the study.