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Exercise as a Tool for Studying the Mechanisms and Applicability of Glycemic Variability (ETSMAGV)

2014年10月13日 更新者:Beatriz D'Agord Schaan、Hospital de Clinicas de Porto Alegre

Exercise as a Tool for Studying the Mechanisms and Applicability of Glycemic Variability in Individuals With and Without Type 2 Diabetes Mellitus

The aim this study is characterize glycemic variability using linear and nonlinear mathematical tools, under basal conditions and in response to specific protocols acute exercise that evoke oxidative stress and inflammation in healthy subjects and type 2 diabetes patients. For this purpose, the sample size will consist of 37 individuals healthy and 32 without type 2 diabetes mellitus wore a CGMS during 3 days. Participants randomly performed aerobic and eccentric sessions, both in the morning (24h after CGMS placement), and at least 7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation (conventional methods) as well as by spectral and symbolic analysis (non-conventional methods). Physiological mechanisms altered by exercise protocols (Human Soluble Interleukin-6 and Glutathione), will be measured in blood samples.

調査の概要

詳細な説明

The aim this study is characterize glycemic variability using linear and nonlinear mathematical tools, under basal conditions and in response to specific protocols acute exercise that evoke oxidative stress and inflammation in healthy subjects and type 2 diabetes patients. For this purpose, the sample size will consist of 37 individuals healthy and 32 without type 2 diabetes mellitus, which will undertake the two types of exercise, randomly distributed. The maximal incremental exercise test will be performed in electrically braked cycle ergometer (ER-900, Jaeger, Wu¨ rzburg, Germany) in order to assess possible contraindications to the proposed protocol as well functional capacity, which will be used in prescription of the aerobic exercise session and a testing strength maximal will be conducted and used in the prescription of the eccentric exercise session.

The glucose variability will be assessed by continuous glucose monitoring system (CGMS) during 72h. Glucose variability will be evaluated by glucose standard deviation, glucose variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation (conventional methods) as well as by spectral and symbolic analysis (non-conventional methods). Physiological mechanisms altered by exercise protocols will be measured in blood samples., Human Soluble Interleukin-6 ( HU IL 6 ELISA KIT - BIOSOURCE) and Glutathione (GSH) indicator of oxidative stress (GSH assay in: Rahman I, Kode A, Biswas SK. Nat Protoc. 2006;1(6):3159-65). The aerobic session will consist of 40 min of lower limb bicycle at 70% of the peak heart rate, as determined in the incremental exercise test and eccentric session will consist of 40 min of one lower -limb exercises (leg press) with 6 sets of 10 repetitions at 120% of 1-RM. The protocol was approved by the Ethics in Research Committee at Hospital de Clínicas de Porto Alegre and all patients will provide their written informed consent before the participation.The research will be performed at the Exercise Pathophysiology Research laboratory of the Hospital de Clínicas de Porto Alegre. We believe that signs of glycemic variability has characteristics detectable by alternative, related to hysiological processes such as oxidative stress and inflammation, evoked by aerobic and eccentric exercise protocols mathematical methods, may help explain the acute response of healthy individuals and patients with type 2 diabetes.

研究の種類

介入

入学 (予想される)

69

段階

  • 適用できない

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

    • RS
      • Porto Alegre、RS、ブラジル、90035-003
        • 募集
        • Hospital de Clinicas de Porto Alegre
        • コンタクト:
        • 主任研究者:
          • Beatriz Schaan, PhD

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

18年~65年 (大人、高齢者)

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:

Type 2 diabetes Male and female 18-65 years old

Exclusion Criteria:

Chronic kidney failure; Limb amputation Diabetic proliferative retinopathy; Regular physical training; Severe autonomic neuropathy; Diabetic nephropathy established; Coronary artery disease; Heart failure; Uncontrolled hypertension Treatment of insulin

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:防止
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
他の:2型糖尿病患者

Exercise intensity for each individual by a heart rate monitor (Polar F1 TM, Polar Electro Oy, Helsinki, Finland), and a Borg 0-10 scale used to register individuals' perceived exertion every 5 minutes throughout the experimental sessions.

Aerobic session will consist of 40 min of lower limb bicycle at 70% of the peak heart rate, as determined in the incremental exercise test.

Eccentric session will consist of 40 min of one lower -limb exercises (leg press) with 6 sets of 10 repetitions at 120% of 1-RM.
Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.
他の:健康

Exercise intensity for each individual by a heart rate monitor (Polar F1 TM, Polar Electro Oy, Helsinki, Finland), and a Borg 0-10 scale used to register individuals' perceived exertion every 5 minutes throughout the experimental sessions.

Aerobic session will consist of 40 min of lower limb bicycle at 70% of the peak heart rate, as determined in the incremental exercise test.

Eccentric session will consist of 40 min of one lower -limb exercises (leg press) with 6 sets of 10 repetitions at 120% of 1-RM.
Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.

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
Glycemic variability by continuous glucose monitoring system
時間枠:The monitor that analyzes the data every 10s and reports average values every 5 min, totalizing 288 readings per day. Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) of 40 min of both exercise.
Will be assessed conventional and non-conventional methods to analyze glucose variability derived from multiple measurements performed with continuous glucose monitoring system (CGMS).Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.
The monitor that analyzes the data every 10s and reports average values every 5 min, totalizing 288 readings per day. Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) of 40 min of both exercise.

二次結果の測定

結果測定
メジャーの説明
時間枠
Oxidative stress
時間枠:10 minutes before the exercise sessions and 10 minutes after the exercise sessions.
Will be assessed by Glutathione (GSH) indicator of oxidative stress (GSH assay in: Rahman I, Kode A, Biswas SK Nat PROTOC 2006, 1 (6): 3159-65.
10 minutes before the exercise sessions and 10 minutes after the exercise sessions.

協力者と研究者

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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。

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

2014年1月1日

一次修了 (予想される)

2015年7月1日

研究の完了 (予想される)

2015年8月1日

試験登録日

最初に提出

2014年9月23日

QC基準を満たした最初の提出物

2014年10月7日

最初の投稿 (見積もり)

2014年10月13日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年10月15日

QC基準を満たした最後の更新が送信されました

2014年10月13日

最終確認日

2014年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 120148

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