Genetic Contribution to the Pathophysiology of the Charcot Foot in Qatari Patients With Diabetes
調査の概要
詳細な説明
Diabetes is a serious health issue for the Qatari population since approximately 1/5 of the population has Type 2 Diabetes, which is 2-3 times higher than the world average. Although much of the clinical studies of diabetes often focused on microvascular phenotypes such as retinopathy and nephropathy, and macrovascular diseases presenting clinically as myocardial infarction, stroke, and peripheral vascular disease, other rare complications such as Charcot foot disease confer a significant burden in Qatar diabetic population, leading to decreased life quality.
Charcot foot is estimated to affect 0.8% to 8% of diabetic populations. It occurs most commonly in patients with diabetes complicated by severe peripheral neuropathy, often with coexisting sympathetic denervation, causing increased blood flow to the foot and increased bone resorption.
Uncontrolled and inappropriate inflammation leading to bone resorption and deformation has been the hallmark of diabetic Charcot foot pathophysiology. There are two major theories that provide the likely mechanism of the disease. The "neurovascular (French) theory" suggests that increased blood flow, as a result of autonomic neuropathy, can lead to bone destruction and mechanical debilitation. On the other hand, the "neurotraumatic (German) theory" argues that the loss of protective sensation leads to unperceived injury and trauma in the insensate foot. One can argue that the pathogenesis of Charcot neuro-arthropathy is most likely a combination of these processes. For unknown reasons, Charcot foot is trigged only in some susceptible individuals with diabetes.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Doha、カタール
- Hamad Medical Corporation
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Must provide informed consent
- Must hold Qatari passport
- Males or Females ages 30 years or older to minimize the potential confounding contribution of other forms of diabetes mellitus
- In patients with Diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity).
- Not taking any chronic medications (except of the diabetes, cardiovascular related drugs, anti-inflammatory drugs and/or any other treatment used for Charcot foot).
Exclusion Criteria:
- Other forms of diabetes (Type I, MODY, secondary diabetes)
- Active pregnancy
- Active infection or acute illness of any kind (except for Charcot foot)
- Chronic inflammation (auto-immune diseases) or infection
- Evidence of malignancy within the past 5 years
- Chronic hematological disorders known to affect HBA1C results such as hemoglobinopathies (e.g., sickle cell disease and thalassemia), increased red-cell turnover (e.g., hemolytic anemia and spherocytosis)
- Acute or critical limb ischemia.
- Osteomyelitis
- History of recent (within 6 months) immunosuppressive treatment including corticosteroids and anti-TNF-alpha compounds.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Group I: T2D and Charcot foot
Individuals with confirmed diagnosis of type 2 diabetes, using the American Diabetes Association guidelines and confirmed diagnosis of Charcot foot, based on clinical and radiological evidence of Charcot foot.
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Group II: T2D neuropathy, no charcot
Individuals with type 2 diabetes and presence of neuropathy but the absence of Charcot foot.
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Group III: Control, non-diabetic
Individuals without history of type 2 diabetes.
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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 |
---|---|---|
Charcot Foot's vascular complications
時間枠:6 months
|
Assess the hypothesis that Charcot Foot is associated with more vascular complications compared to match diabetic patients without Charcot foot
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6 months
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Charcot foot in monocyte epigenetics
時間枠:6 months
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Assess the hypothesis that Charcot foot disease reflects differences in monocyte epigenetics compared to other controls, particularly in genes involved in inflammation.
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6 months
|
Assess the effect of initial methylation on kidney function in patients with type 2 diabetes mellitus, weather they have or not Charcot foot disease and for whom we have baseline kidney function, in a 2-year follow-up.
時間枠:6 months
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6 months
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HBA1C >8.5% on total and gene-specific methylation.
時間枠:6 months
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Assess the effect of improving diabetes control in patients with type 2 diabetes (Charcot foot and non-charcot foot patients) and a HBA1C >8.5% on total and gene-specific methylation.
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6 months
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協力者と研究者
捜査官
- 主任研究者:Charbel Abi Khalil, MD、Weill Cornell Medical College in Qatar
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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?
IPD プランの説明
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。
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