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

NCT07660081 | Active Not Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2026/05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis; Type 2 Diabetes; Obesity

Keywords

Randomized Controlled Trial; Acetyl L-Carnitine; Postmenopausal Women; Oxidative Stress

Outcome Measures

Primary Outcomes (12)

• Change in C-Reactive Protein (CRP)

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

  Baseline and Week 12

• Change in Fasting Blood Glucose

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

  Baseline and Week 12

• Change in Glycated Hemoglobin (HbA1c)

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

  Baseline and Week 12

• Change in Insulin Resistance (HOMA-IR)

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

  Baseline and Week 12

• Change in Serum Insulin

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

  Baseline and Week 12

• Change in Serum Leptin

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

  Baseline and Week 12

• Change in Serum Adiponectin

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

  Baseline and Week 12

• Change in Adrenocorticotropic Hormone (ACTH)

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

  Baseline and Week 12

• Change in Malondialdehyde (MDA)

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

  Baseline and Week 12

• Change in Advanced Glycation End Products (AGEs)

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

  Baseline and Week 12

• Change in WOMAC Osteoarthritis Score

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

  Baseline and Week 12

• Change in Kellgren-Lawrence Radiographic Grade

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

  Baseline and Week 12

Secondary Outcomes (1)

• Change in Interleukin-6 (IL-6)

  Baseline and Week 12

Study Arms (2)

Acetyl L-Carnitine Group

EXPERIMENTAL

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.

Drug: Acetyl-l-carnitine

Placebo Control Group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

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.

Also known as: ALCAR, L-Carnitine (if used locally)

Acetyl L-Carnitine Group

Placebo DRUG

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

Also known as: Placebo capsules

Placebo Control Group

Eligibility Criteria

• Age: 55 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Khalifa Gulnawaz Teaching Hospital, DHQ Teaching Hospital

Bannu, KPK, 28100, Pakistan

Location

Related Publications (6)

• GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.

  PMID: 37675071 BACKGROUND

• Prieto-Alhambra D, Judge A, Javaid MK, Cooper C, Diez-Perez A, Arden NK. Incidence and risk factors for clinically diagnosed knee, hip and hand osteoarthritis: influences of age, gender and osteoarthritis affecting other joints. Ann Rheum Dis. 2014 Sep;73(9):1659-64. doi: 10.1136/annrheumdis-2013-203355. Epub 2013 Jun 6.

  PMID: 23744977 BACKGROUND

• Thijssen E, van Caam A, van der Kraan PM. Obesity and osteoarthritis, more than just wear and tear: pivotal roles for inflamed adipose tissue and dyslipidaemia in obesity-induced osteoarthritis. Rheumatology (Oxford). 2015 Apr;54(4):588-600. doi: 10.1093/rheumatology/keu464. Epub 2014 Dec 11.

  PMID: 25504962 BACKGROUND

• Francisco V, Tovar S, Conde J, Pino J, Mera A, Lago F, Gonzalez-Gay MA, Dieguez C, Gualillo O. Levels of the Novel Endogenous Antagonist of Ghrelin Receptor, Liver-Enriched Antimicrobial Peptide-2, in Patients with Rheumatoid Arthritis. Nutrients. 2020 Apr 6;12(4):1006. doi: 10.3390/nu12041006.

  PMID: 32268520 BACKGROUND

• Lu Q, Zhang Y, Elisseeff JH. Carnitine and acetylcarnitine modulate mesenchymal differentiation of adult stem cells. J Tissue Eng Regen Med. 2015 Dec;9(12):1352-62. doi: 10.1002/term.1747. Epub 2013 Apr 29.

  PMID: 23625722 BACKGROUND

• Walker C, Faustino A, Lanas A. Monitoring complete blood counts and haemoglobin levels in osteoarthritis patients: results from a European survey investigating primary care physician behaviours and understanding. Open Rheumatol J. 2014 Dec 19;8:110-5. doi: 10.2174/1874312901408010110. eCollection 2014.

  PMID: 25598854 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Diabetes Mellitus, Type 2; Obesity

Interventions

Acetylcarnitine; Carnitine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Dr Safia Bibi, PhD*

  Khyber Medical University Peshawar, Pakistan

  PRINCIPAL INVESTIGATOR

• Dr Mohsin Shah, PhD

  Khyber Medical University Peshawar, Pakistan

  PRINCIPAL INVESTIGATOR

• Dr Zia Ullah, PhD

  Khalifa Gul Nawaz Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel groups: conventional treatment plus placebo or conventional treatment plus Acetyl L-Carnitine (1.5 g twice daily) for 12 weeks. Outcomes will be assessed at baseline and after intervention.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: November 1, 2025
• Primary Completion: July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
• Access Criteria: 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.

Locations

PA (1)