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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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.
Matching placebo capsules administered orally twice daily for 12 weeks in addition to conventional osteoarthritis treatment.
Khalifa Gulnawaz Teaching Hospital, DHQ Teaching Hospital
Bannu, KPK, Pakistan
Serum C-Reactive Protein Concentration
Change in Serum C-Reactive Protein (CRP) Concentration (mg/L) from baseline following 12 weeks of Acetyl L-Carnitine supplementation.
Time frame: Baseline and Week 12
Fasting Blood Glucose Concentration
Change in fasting blood glucose levels (mg/dL) from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
Glycated Hemoglobin (HbA1c) Percentage
Change in HbA1c levels (%) from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
Fasting Serum Insulin Concentration
Change in fasting serum insulin concentration (µIU/mL) from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
Serum Leptin Concentration
Change in serum leptin concentration (ng/mL) from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
Serum Adiponectin Concentration
Change in serum adiponectin concentration (µg/mL) from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
Serum Adrenocorticotropic Hormone (ACTH) Concentration
Change in serum ACTH concentration from baseline following 12 weeks of intervention
Time frame: Baseline and Week 12
Serum Malondialdehyde (MDA) Concentration
Change in serum malondialdehyde levels as a marker of oxidative stress from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
Serum Advanced Glycation End Products (AGEs) Concentration
Change in serum AGEs levels from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
WOMAC Osteoarthritis Index total Score
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
Kellgren-Lawrence Radiographic Grade
Change in osteoarthritis radiographic severity assessed by the Kellgren-Lawrence grading system from baseline following 12 weeks of intervention.
Time frame: Baseline and Week 12
Interleukin-6 (IL-6)
Change in serum IL-6 concentration from baseline following 12 weeks of Acetyl L-Carnitine supplementation.
Time frame: Baseline and Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.