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OsteoarthritisNCT07660081

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

A study testing Acetyl-l-carnitine in people with Osteoarthritis and Type 2 Diabetes, run by Khyber Medical University Peshawar at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Osteoarthritis, Type 2 Diabetes, Obesity
What is being tested?
Acetyl-l-carnitine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 sitePakistan
Study dates
1 Dec 2025to 15 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Khalifa Gulnawaz Teaching Hospital, DHQ Teaching Hospital

    Bannu, KPK, 28100

Other trials in Pakistan

About this study

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

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.

Read the detailed description

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.

Being tested
Acetyl-l-carnitine, Placebo
Keywords
Randomized Controlled Trial, Acetyl L-Carnitine, Postmenopausal Women, Oxidative Stress
Medical subject headings
Osteoarthritis, Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetyl-l-carnitineDrug

    Also called ALCAR, L-Carnitine (if used locally)

    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.

  • PlaceboDrug

    Also called Placebo capsules

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

Study groups in NCT07660081
Study groupRoleWhat they receive
Acetyl L-Carnitine GroupExperimentalParticipants 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.
Receives: Drug: Acetyl-l-carnitine
Placebo Control GroupPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 12

  2. Fasting Blood Glucose Concentration

    Change in fasting blood glucose levels (mg/dL) from baseline following 12 weeks of intervention.

    Measured: Baseline and Week 12

  3. Glycated Hemoglobin (HbA1c) Percentage

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

    Measured: Baseline and Week 12

  4. 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.

    Measured: Baseline and Week 12

  5. Fasting Serum Insulin Concentration

    Change in fasting serum insulin concentration (µIU/mL) from baseline following 12 weeks of intervention.

    Measured: Baseline and Week 12

  6. Serum Leptin Concentration

    Change in serum leptin concentration (ng/mL) from baseline following 12 weeks of intervention.

    Measured: Baseline and Week 12

  7. Serum Adiponectin Concentration

    Change in serum adiponectin concentration (µg/mL) from baseline following 12 weeks of intervention.

    Measured: Baseline and Week 12

  8. Serum Adrenocorticotropic Hormone (ACTH) Concentration

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

    Measured: Baseline and Week 12

  9. Serum Malondialdehyde (MDA) Concentration

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

    Measured: Baseline and Week 12

  10. Serum Advanced Glycation End Products (AGEs) Concentration

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

    Measured: Baseline and Week 12

  11. WOMAC Osteoarthritis Index total Score

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

    Measured: Baseline and Week 12

  12. Kellgren-Lawrence Radiographic Grade

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

    Measured: Baseline and Week 12

Secondary outcomes (1)
  1. Interleukin-6 (IL-6)

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

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start1 Dec 2025
  3. Primary completion15 Jul 2026
  4. Study completion15 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07660081
Sponsor's protocol ID
KMU/DIR/CTU/2026/05
Status last verified
Sep 2026
First submitted
16 Jun 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37675071
  • 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.

    PubMed 23744977
  • 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.

    PubMed 25504962
  • 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.

    PubMed 32268520
  • 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.

    PubMed 23625722
  • 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.

    PubMed 25598854

Questions about this trial

What is this clinical trial studying?

A study testing Acetyl-l-carnitine in people with Osteoarthritis and Type 2 Diabetes, run by Khyber Medical University Peshawar at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum C-Reactive Protein Concentration (time frame: Baseline and Week 12). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07660081, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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