The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial (VIGOR)
Background/Justification: Regular physical activity (PA) has substantial health benefits in persons with type 1 diabetes (T1D), including reduced risk of complications and cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly less active than their peers without diabetes. Two major factors likely explain the low rates of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e. walking) PA sessions may overcome these limitations. No studies have tested the efficacy of high intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic variability in a randomized controlled trial (RCT).
Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate intensity PA intervention will elicit significant improvements in glycemic excursions, as measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period following exercise.We are also exploring the hypothesis that reducing the risk of hypoglycemia will lead to a sustained increase in physical activity one year after randomization.
調査の概要
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
-
-
Alberta
-
Calgary、Alberta、カナダ、T2N 1N4
- University Of Calgary
-
Edmonton、Alberta、カナダ、T6G 2R3
- University of Alberta
-
-
Manitoba
-
WInnipeg、Manitoba、カナダ、R3E 3P4
- Manitoba Institute of Child Health
-
-
Ontario
-
Hamilton、Ontario、カナダ、L8S 4L8
- McMaster University
-
Ottawa、Ontario、カナダ、K1N 6N5
- University of Ottawa
-
-
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:
- Age: 15-45 years old
- Have lived with type 1 diabetes for at least 2 years
- HbA1c <9.9%
- Currently physically inactive (<150 minutes of self-reported structured physical activity per week)
- Undergone a resting ECG to screen for left ventricular hypertrophy, arrhythmias or signs or coronary artery disease that may be exacerbated with vigorous intensity exercise
Exclusion Criteria:
- Have frequent and unpredictable hypoglycaemia
- Had a change in insulin management strategy, including adoption of a pump, within 2 months of enrolment
- Are currently participating in structured activity or sport-related activities
- Are women who are pregnant or planning to get pregnant within the 12 months of the trial and those who are breastfeeding
- Have conditions that would render physical activity contraindicated including: uncontrolled hypertension (BP>150mmHg systolic or >95mmHg diastolic in a sitting position); severe peripheral neuropathy; history of cardiovascular disease
- Have a cognitive deficit resulting in an inability to provide informed consent
- Currently taking beta blockers
- Currently taking atypical antipsychotics or corticosteroids
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
アクティブコンパレータ：Moderate intensity exercise
150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)
|
|
|
アクティブコンパレータ：Moderate + Vigorous Intensity Exercise
150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)
|
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 |
|---|---|
|
Time Spent in Hypoglycaemia in the 12-hour Period Following Exercise, Defined as an Interstitial Glucose Reading <4.0mmol/L and Measured by Continuous Glucose Monitor.
時間枠：Measured at baseline, and 1, 8,16 and 52 weeks following randomization
|
Measured at baseline, and 1, 8,16 and 52 weeks following randomization
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Glycaemic Variability, Measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour Period Following Exercise. This is Calculated From the Same Continuous Glucose Monitor Data as the Primary Outcome.
時間枠：Measured at baseline, and 1, 8, 16 and 52 weeks following randomization
|
Measured at baseline, and 1, 8, 16 and 52 weeks following randomization
|
協力者と研究者
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。