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

2026年9月14日更新者：Khyber Medical University Peshawar

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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

100

段階

適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

パキスタン
- KPK
  - Bannu、KPK、パキスタン、28100
    - Khalifa Gulnawaz Teaching Hospital, DHQ Teaching Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

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

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：処理
割り当て：ランダム化
介入モデル：並列代入
マスキング：ダブル

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：Acetyl L-Carnitine Group 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.	薬：Acetyl-l-carnitine 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. 他の名前： ALCAR, L-Carnitine (if used locally)
プラセボコンパレーター：Placebo Control Group 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.	薬：Placebo Matching placebo capsules administered orally twice daily for 12 weeks in addition to conventional osteoarthritis treatment. 他の名前：プラセボカプセル

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Serum C-Reactive Protein Concentration 時間枠：Baseline and Week 12	Change in Serum C-Reactive Protein (CRP) Concentration (mg/L) from baseline following 12 weeks of Acetyl L-Carnitine supplementation.	Baseline and Week 12
Fasting Blood Glucose Concentration 時間枠：Baseline and Week 12	Change in fasting blood glucose levels (mg/dL) from baseline following 12 weeks of intervention.	Baseline and Week 12
Glycated Hemoglobin (HbA1c) Percentage 時間枠：Baseline and Week 12	Change in HbA1c levels (%) from baseline following 12 weeks of intervention.	Baseline and Week 12
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) 時間枠：Baseline and Week 12	Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score from baseline following 12 weeks of intervention.	Baseline and Week 12
Fasting Serum Insulin Concentration 時間枠：Baseline and Week 12	Change in fasting serum insulin concentration (µIU/mL) from baseline following 12 weeks of intervention.	Baseline and Week 12
Serum Leptin Concentration 時間枠：Baseline and Week 12	Change in serum leptin concentration (ng/mL) from baseline following 12 weeks of intervention.	Baseline and Week 12
Serum Adiponectin Concentration 時間枠：Baseline and Week 12	Change in serum adiponectin concentration (µg/mL) from baseline following 12 weeks of intervention.	Baseline and Week 12
Serum Adrenocorticotropic Hormone (ACTH) Concentration 時間枠：Baseline and Week 12	Change in serum ACTH concentration from baseline following 12 weeks of intervention	Baseline and Week 12
Serum Malondialdehyde (MDA) Concentration 時間枠：Baseline and Week 12	Change in serum malondialdehyde levels as a marker of oxidative stress from baseline following 12 weeks of intervention.	Baseline and Week 12
Serum Advanced Glycation End Products (AGEs) Concentration 時間枠：Baseline and Week 12	Change in serum AGEs levels from baseline following 12 weeks of intervention.	Baseline and Week 12
WOMAC Osteoarthritis Index total Score 時間枠：Baseline and Week 12	Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline following 12 weeks of intervention.	Baseline and Week 12
Kellgren-Lawrence Radiographic Grade 時間枠：Baseline and Week 12	Change in osteoarthritis radiographic severity assessed by the Kellgren-Lawrence grading system from baseline following 12 weeks of intervention.	Baseline and Week 12

二次結果の測定

結果測定	メジャーの説明	時間枠
Interleukin-6 (IL-6) 時間枠：Baseline and Week 12	Change in serum IL-6 concentration from baseline following 12 weeks of Acetyl L-Carnitine supplementation.	Baseline and Week 12

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Khyber Medical University Peshawar

捜査官

主任研究者：Dr Safia Bibi, PhD*、Khyber Medical University Peshawar, Pakistan
主任研究者：Dr Mohsin Shah, PhD、Khyber Medical University Peshawar, Pakistan
主任研究者：Dr Zia Ullah, PhD、Khalifa Gul Nawaz Teaching Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年12月1日

一次修了 (実際)

2026年7月15日

研究の完了 (実際)

2026年8月15日

試験登録日

最初に提出

2026年6月16日

QC基準を満たした最初の提出物

2026年6月16日

最初の投稿 (実際)

2026年6月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月17日

QC基準を満たした最後の更新が送信されました

2026年9月14日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

KMU/DIR/CTU/2026/05

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

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

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

STUDY_PROTOCOL
SAP
ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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