Adipokines in Obese Adolescents With Insulin Resistance
2012年4月23日 更新者：Maria Lola Evia-Viscarra、Hospital Regional de Alta Especialidad del Bajio
Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial
The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).
調査の概要
詳細な説明
The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of disability and/or premature death.
The current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR, dyslipidemia, and inflammatory processes, are perpetuated.
Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have observed decreases in IR, decreases in weight, and improvements in lipid metabolism.
Adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered to be a risk marker for the development of cardiovascular disease.
研究の種類
介入
入学 (実際)
31
段階
- フェーズ 4
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
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Distrito Federal
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México、Distrito Federal、メキシコ、06720
- Hospital Infantil de Mexico Federico Gomez
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Guanajuato
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León、Guanajuato、メキシコ、37670
- Hospital Regional de Alta Especialidad del Bajio
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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
9年～18年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Obesity defined as Body Mass Index (BMI) ≥ percentile 95
- Tanner stage ≥ 2
- Insulin resistance defined as Basal insulin > 15 µU/mL or Homeostasis Model Assessment index (HOMA) > 4.5
- Patients' parents signed written consents when they and their adolescent children agreed to enroll
Exclusion Criteria:
- Glucose intolerance
- Diabetes mellitus (type 1 or 2)
- Anemia (Hb < 10 g/dL)
- Plasma creatinine > 1.4 mg/dL
- Abnormal hepatic function
- Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
- History of lactic acidosis
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
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Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
他の名前：
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プラセボコンパレーター：Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.
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Tablet of 500 mg oral placebo every 12 hours for 3 months.
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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 |
|---|---|---|
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Adiponectin
時間枠：baseline and 3 months
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Change from baseline in Adiponectin after 3 months of treatment.
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baseline and 3 months
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High-sensitivity C-reactive Protein
時間枠：baseline and 3 months
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Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.
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baseline and 3 months
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Interleukin 6
時間枠：baseline and 3 months
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Change from baseline in Interleukin 6 after 3 months of treatment.
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baseline and 3 months
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Tumour Necrosis Factor Alpha
時間枠：baseline and 3 months
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Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
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baseline and 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fasting Plasma Glucose
時間枠：baseline and 3 months
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Change from baseline in Fasting plasma glucose after 3 months of treatment.
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baseline and 3 months
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Fasting Insulin
時間枠：baseline and 3 months
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Change from baseline in Fasting insulin after 3 months of treatment.
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baseline and 3 months
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Body Mass Index
時間枠：baseline and 3 months
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Change from baseline in Body Mass Index after 3 months of treatment.
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baseline and 3 months
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Waist Circumference
時間枠：baseline and 3 months
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Change from baseline in Waist circumference after 3 months of treatment.
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baseline and 3 months
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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。
捜査官
- 主任研究者：Maria L Evia-Viscarra, M.D.、Hospital Regional de Alta Especialidad del Bajio
- スタディチェア：Edel R Rodea-Montero, Statistician、Hospital Regional de Alta Especialidad del Bajio
- スタディチェア：Evelia Apolinar-Jiménez, Nutrition、Hospital Regional de Alta Especialidad del Bajio
- スタディチェア：Leticia M García-Morales, M.D.、Hospital Infantil de Mexico Federico Gomez
- スタディチェア：Constanza Leaños-Pérez, M.D.、Hospital Infantil de Mexico Federico Gomez
- スタディチェア：Mireya Figueroa-Barrón, Chemestry、Hospital Infantil de Mexico Federico Gomez
- スタディチェア：Dolores Sánchez-Fierros, Chemestry、Hospital Infantil de Mexico Federico Gomez
- スタディチェア：Nathalie Muñoz-Noriega, Nutrition、Hospital Regional de Alta Especialidad del Bajio
- スタディチェア：Juan G Reyes-García, M.D.、Escuela Superior de Medicina del IPN
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
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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
2007年1月1日
一次修了 (実際)
2009年12月1日
研究の完了 (実際)
2010年3月1日
試験登録日
最初に提出
2011年8月4日
QC基準を満たした最初の提出物
2011年8月4日
最初の投稿 (見積もり)
2011年8月5日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年4月27日
QC基準を満たした最後の更新が送信されました
2012年4月23日
最終確認日
2012年4月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 010-08
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。
Metforminの臨床試験
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Tan Tock Seng Hospital募集
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Cairo Universityわからない