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治験 NCT01377558（対象：2型糖尿病）は状況不明です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ユストゥス・リービッヒ大学ギーセンEffects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes 100 運動療法
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT01377558 は 介入研究 臨床試験 で、2型糖尿病 に関するものです。現在は 状況不明 で、2011年4月1日 から開始しています。100 名の参加者 の募集が計画されています。この試験は ユストゥス・リービッヒ大学ギーセン によって主導され、2012年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2011年6月23日 です。
概要
The purposes of the study are
- to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients
- to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving q...
詳細説明
Meta-analyses which evaluated the effects of structured exercise programs in patients with type 2 diabetes demonstrate that regular physical activity improves glycosylated haemoglobin (König et al.: Resistance Exercise and Type 2 Diabetes Mellitus, Deutsche Zeitschrift für Sportmedizin Jahrgang 62, Nr. 1 (2011): 5-9). Sigal et al. proved that either aerobic or resistance training alone improved glycemic control in ty...もっと見る
公式タイトル
Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes - Aerobic Endurance Training Versus Strength Endurance Training Versus Combined Aerobic Endurance and Strength Endurance Training -
疾患名
2型糖尿病その他の研究識別子
- Gi-03-2011
NCT番号
開始日
2011-04
最終更新日
2011-06-23
終了予定日
2012-06
目標参加者数
100
試験の種類
介入研究
治験の相・段階
該当なし
状況
状況不明
キーワード
aerobic training
resistance training
combination of aerobic and resistance training
diabetes
type 2 diabetes
HbA1c
endothelial dysfunction
inflammation markers
Parodontitis
Exercise intervention
training
resistance training
combination of aerobic and resistance training
diabetes
type 2 diabetes
HbA1c
endothelial dysfunction
inflammation markers
Parodontitis
Exercise intervention
training
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Aerobic endurance training intervention Aerobic endurance training | Aerobic endurance training intervention The aerobic endurance training group will use cardiovascular training devices
week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT two times per week
week 5-13: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT two times per week
week 14-26: 15 minutes warm up (group) 45 minutes intervention at 95-110% vAT two times per week |
実験的Strength endurance training intervention Strength endurance training | Strength endurance training intervention The strength endurance training intervention group will perform eight exercises on weight machines (Milon circuit training- 60 seconds activity, 30 seconds break)
week 1-4: 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) two times per week
week 5-13: 15 minutes warm up (group) 2 sessions resistance training intensity 5 (Buskies) two times per week
week 14-26: 15 minutes warm up (grou...もっと見る |
実験的Combined training intervention Combined aerobic endurance training and strength endurance training intervention | Combined aerobic endurance and strength endurance training week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT once per week and 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) once per week
week 5-13: 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) two times per week
week 14-26: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT a...もっと見る |
非介入Control group control group | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in HbA1c-level (haemoglobin A1c) | 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in HOMA-Index | 3 and 6 months | |
Change in beta-cell-function | Measured by OGTT (Oral Glucose Tolerance Test) | 3 and 6 months |
Change in fasting plasma glucose levels | 3 and 6 months | |
Change in total cholesterol levels | 3 and 6 months | |
Change in HDL-cholesterol levels | 3 and 6 months | |
Change in LDL-cholesterol levels | 3 and 6 months | |
Change in triglyceride levels | 3 and 6 months | |
Change in antidiabetic medications | Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months | 3 and 6 months |
Change in inflammation markers | CrP, blood count, interleukinstatus, cytokinstatus | 3 and 6 months |
Change in body weight | 3 and 6 months | |
Change in body composition | by Bio-impedance analysis, waist to hip ratio, range of thigh | 3 and 6 months |
Change in strength | by Dr. Wolff Back Check | 3 and 6 months |
Change of maximum heart rate | Measured by an incremental exercise test | 3 and 6 months |
Change of peak oxygen uptake | Measured by an incremental exercise test | 3 and 6 months |
Change of vAT (ventilatory anaerobic threshold) | Measured by an incremental exercise test | 3 and 6 months |
Change in blood pressure | 3 and 6 months | |
Change in renal function | Creatininlevel, Albuminlevel (urine), Telomere length | 3 and 6 months |
Change in concentration | by d2-test | 3 and 6 months |
Change in quality of life | by questionnaire: SF-12, EQ5 | 3 and 6 months |
Change of nutrition | by questionnaire: FEV, FFQ | 3 and 6 months |
Change in voluntary physical activity | meassured by pedometer (one week) | 3 and 6 months |
Change of cardiac output by Impedance cardiography | by Task Force Monitor | 3 and 6 months |
Change of barorezeptorsensitivity | by Task Force Monitor | 3 and 6 months |
Change in carotid-Intima-Media-Thickness | 3 and 6 months | |
Change in aortic pulse-wave velocity | 3 and 6 months | |
Change in central aortic pressure | 3 and 6 month | |
Change in endothelial dysfunction | 3 and 6 months | |
Change of parodontitis | 3 and 6 months | |
Follow up of all parameters mentioned above | Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention | after 12 months |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- diagnoses of type 2 diabetes (ADA criteria)
- admitted diabetes treatments will be diet and oral hypoglycemic agents
- sports intervention >60 minutes per week
- medical conditions
- preproliferative or proliferative retinopathy
- instable coronary heart disease
- inability to perform the scheduled physical activity programs
- acute clinically significant intercurrent diseases
ユストゥス・リービッヒ大学ギーセン33 件のアクティブな治験を探索ハノーファー医科大学49 件のアクティブな治験を探索連絡先情報がありません。
2 1カ国の場所
Hesse
University of Giessen, Giessen, Hesse, 35394, Germany
Saxony
Sportpark Zwickau, Glauchau, Meerane, Zwickau, Saxony, 08056, Germany