Lifestyle Therapy for Youth With Type 2 Diabetes (BDT)
Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes
Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased physical activity and dietary changes) for the management of glycemia and cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM).
Our hypothesis is that education regarding healthy lifestyle changes will significantly reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL cholesterol, serum triglycerides and apolipoprotein B.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Manitoba
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Winnipeg、Manitoba、カナダ、R3E 0P4
- Manitoba Institute of Child 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
説明
Inclusion Criteria:
- youth with a BMI considered overweight according to the International Obesity Task Force
- diagnosed with type 2 diabetes, confirmed with a 2-hour oral glucose tolerance test within two years of enrollment
Exclusion Criteria:
- youth with type 1 diabetes
- use of insulin or other anti-diabetic drugs
- youth with medication-induced diabetes
- youth who have recently been admitted to hospital with ketoacidosis
- youth have experienced weight loss or enrolled in a weightloss program in the last 6 months
- youth with an orthapaedic injury preventing them from exercising
- youth who have a history of alcohol or drug abuse
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
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
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:Lifestyle counselling
Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting
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Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices
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介入なし:Control
Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention
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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 |
時間枠 |
---|---|
Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
時間枠:16 weeks
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16 weeks
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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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Cardiometabolic risk Z score
時間枠:16 weeks
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This is a composite score based on BMI z-score, waist circumference, c-reactive protein (CRP), fibrinogen, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triglycerides (TG) and apolipoprotein B (apoB), and a marker of fatty liver disease, alanine transaminase (ALT)
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16 weeks
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Presence of microalbuminuria
時間枠:16 weeks
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defined as a first morning albumin:creatinine ratio (ACR) 2.5-25 mg/mmol in a first morning urine collection
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16 weeks
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Hypertension
時間枠:16 weeks
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defined as a systolic blood pressure load >25% or a mean 24 hour systolic blood pressure >95th %ile for sex and height on 24 hour ambulatory blood pressure monitoring
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16 weeks
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Anthropometrics
時間枠:16 weeks
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Waist circumference in centimeters, body mass index (BMI) z-score and percent body fat will be assessed to determine if changes in body composition are associated with improvements in cardiometabolic risk
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16 weeks
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Cardiovascular structure and function
時間枠:16 weeks
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Vascular health will be assessed with non-invasive assessments of arterial stiffness, endothelium-dependant relaxation and carotid intima media thickness which will be treated as continuous variables.
Left ventricular structure and function will be assessed using standard M-mode and doppler ultrasound techniques
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16 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Jonathon McGavock, PhD、University of Manitoba
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 (見積もり)
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。
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