MR Imaging of Fat Deposition in Adolescents With First Time Antipsychotic Use
調査の概要
状態
条件
詳細な説明
Atypical Antipsychotics (AAPs) are known to cause metabolic dysfunction, and adolescents are especially vulnerable to this effect. The anthropometric measures routinely used to monitor these metabolic side effects may, in fact, underestimate risk in the pediatric population as they are not a good index of hepatic and visceral adipose tissue.
This study will measure fat accumulation over a 12 week period in adolescents and young adults taking an AAP for the first time. MRI imaging will measure hepatic, and visceral adipose tissue at baseline and study end. An Oral Glucose Tolerance Test will measure glucose resistance and insulin sensitivity. In an exploratory fashion, investigators will also image the brain to assess for volumetric changes which may occur in association with AAP treatment and changes in metabolic indices.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5T1R8
- Centre for Addiction and Mental Health
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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:
- AP naïve or AP-free for 3 months or greater
- prescribed an AP for treatment
- age 12-35
- using contraceptive (females of child bearing age)
Exclusion Criteria:
- currently taking AP or been taking AP for greater than 1 week within the past 3 months
- pregnant or planning to become pregnant
- eating disorder (active or previous)
- clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease
- major medical or surgical event in the preceding 3 months
- acute suicidal risk
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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AP Naive
Group followed over 12 weeks to measure fat deposition, insulin resistance, and glucose tolerance.
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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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Change in hepatic and visceral adipose tissue from baseline to 3 months
時間枠：Baseline and 3 months
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Adipose tissue is measured by an MRI.
Fat content will be compared between baseline and study end (3 months).
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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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Change in glucose tolerance from baseline to 3 months.
時間枠：Baseline and 3 months
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An Oral Glucose Tolerance Test (OGTT) will measure these outcomes at baseline and study end (3 months).
Glucose is measured fasting (mmol/L) at the start of the OGTT and then 2 hours post glucose drink.
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Baseline and 3 months
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Change in insulin sensitivity from baseline to 3 months.
時間枠：Baseline and 3 months
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An Oral Glucose Tolerance Test (OGTT) will measure these outcomes at baseline and study end (3 months).
Insulin is measured fasting (pmol/L) at the start of the OGTT and then 2 hours post glucose drink.
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Baseline and 3 months
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Body Mass Index (BMI)
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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BMI in kg/m^2
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Baseline, 4 weeks, 8 weeks, 12 weeks
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Change in appetite
時間枠：Baseline and 3 months
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Visual analog scale
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Baseline and 3 months
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Change in weight
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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Weight in kilograms
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Baseline, 4 weeks, 8 weeks, 12 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of life
時間枠：Baseline and 3 months
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Assessed with the Pediatric Quality of Life (PedsQL) self-report questionnaire.
Items are rated from 1 to 5, with a score of 5 indicating higher levels of quality of life.
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Baseline and 3 months
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協力者と研究者
捜査官
- 主任研究者：Margaret Hahn, MD, PhD、Centre for Addiction and Mental Health
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
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。