Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07660081

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age55 Years to 65 Years

SexFemale

Healthy volunteersAccepted

ConditionOsteoarthritis, Type 2 Diabetes, Obesity

Full registry criteria

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

Treatments and study arms

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.

Placebo

Drug

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

Primary outcomes

Change in C-Reactive Protein (CRP)Baseline and Week 12

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

Change in Fasting Blood GlucoseBaseline and Week 12

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

Change in Glycated Hemoglobin (HbA1c)Baseline and Week 12

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

Change in Insulin Resistance (HOMA-IR)Baseline and Week 12

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

Change in Serum InsulinBaseline and Week 12

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

Change in Serum LeptinBaseline and Week 12

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

Change in Serum AdiponectinBaseline and Week 12

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

Change in Adrenocorticotropic Hormone (ACTH)Baseline and Week 12

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

Study locations

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Khalifa Gulnawaz Teaching Hospital, DHQ Teaching Hospital🌐 Bannu, KPK, Pakistan

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