Circadian Rhythm and Metabolic Effects of Exercise (HITMet)
2021年11月11日 更新者：Harriet Wallberg、Karolinska Institutet
Time of Day Specific Glycaemic and Metabolic Response to High-Intensity Interval Training
Physical exercise is efficacious in controlling blood glucose levels in individuals with Type 2 diabetes.
An individual's exercise capacity and ability to utilize glucose as an energy source oscillates throughout the day.
Hence, the beneficial effects of exercise on blood glucose levels may depend on the time of day when the exercise bout is performed.
However, the time of day in which the most beneficial adaptations to exercise can be achieved remains unknown.
This project aims to answer the following questions: Does time of day impact the beneficial effects of exercise on blood glucose?
If so, when can the most beneficial effects of exercise be achieved?
Which metabolic mechanisms links time of day, exercise and blood glucose control?
To address these questions, individuals with or without Type 2 diabetes will perform an exercise session at two different times (09:00 and 16:00), and continuous glucose monitoring will be used to assess the effects of exercise on blood glucose.
We will determine the specific metabolic processes which promote the most beneficial blood glucose response.
To achieve this, we will measure which metabolic substrates (carbohydrates, lipids and proteins) are used and which metabolites produced in blood, skeletal muscle and adipose tissue in response to exercise at different times of the day.
調査の概要
詳細な説明
Exercise has well-established metabolic benefits and is a preferred intervention for Type 2 diabetes prevention and management. Metabolic determinants of exercise such as skeletal muscle and whole-body substrate oxidation capacity, glucose tolerance and insulin sensitivity and adipose tissue fatty acid release all show circadian oscillations. These rhythms may promote substantially different responses depending on the time of day when exercise is performed.
This is an exploratory study aiming to determine whether exercise at specific times of day can amplify the beneficial effects on glycemia and metabolism in twi groups of individuals: those with normal glucose tolerance (NGT) or Type 2 diabetes (n=40 per group). The primary objective is to determine the glycemic response to an exercise bout at two distinct times of day, measured by continuous glucose monitoring, in men and women with NGT or Type 2 diabetes. The secondary aim is to identify specific metabolites which facilitate the strongest glycemic response to exercise by examining the whole-body and peripheral tissue metabolomic response to an exercise bout.
The primary goal of the study is to examine the glycemic and metabolic response to exercise within-group for participants with NGT or Type 2 diabetes. Further comparisons will be made between groups with NGT or Type 2 diabetes, across sexes, and by individual chronotype (determined by a standardized questionnaire) to examine the variation in the exercise response across these parameters.
研究の種類
介入
入学 (予想される)
80
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。
研究連絡先
- 名前：Harriet Wallberg-Henriksson, MD PhD
- 電話番号：+46-(0)70-629 64 70
- メール：harriet.wallberg@ki.se
研究場所
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Stockholm、スウェーデン、17070
- 募集
- Karolinska Institutet
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コンタクト：
- Håkan Karlsson, PhD
- 電話番号：+46-(0)73-712 14 37
- メール：hakan.karlsson.1@ki.se
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主任研究者：
- Harriet Wallberg-Henriksson, MD PhD
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-
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
45年～68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:
- Body Mass Index (BMI): 23 - 33 kg/m2
- Participants diagnosed with Type 2 Diabetes (insulin independent) or Normal Glucose Tolerant (2h oral glucose tolerance test within normal range).
- Ability to provide informed consent
- Ability to complete the exercise regiment
Exclusion Criteria:
- Medications: Insulin
- Current nicotine user (cigarettes, snus, nicotine gum) or past nicotine users less than 6 months before inclusion in the study
- Pre-existing cardiovascular condition (Angina pectoris, Cardiac arrhythmia, Cardiac infarction, Coronary stent / angiography, Cerebrovascular insult, Hypertension [> 160 mmHg systolic, or > 95 mmHg diastolic])
- Pre-existing blood-borne disease (HIV, Hepatitis C, MRSA)
- Pre-existing systemic or localized rheumatic illness
- Malignant Disease
- Pre-existing psychiatric disorder
- Another pre-existing systemic disease
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：基礎科学
- 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：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 |
|---|---|
|
実験的：Morning First
Participants will complete a single bout of exercise at 09:00, and after at least a one-week washout perform another exercise bout at 16:00.
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The participants will perform a low-volume, High-intensity Intermittent Exercise bout on a cycle ergometer.
Peak exercise capacity of the study participants will be determined on a separate occasion using a ramp-up maximal oxygen consumption test (VO2peak).
A single exercise bout will consist of a 7-minute warm-up on a cycle ergometer, followed by 6 1-minute intervals of cycling at individual maximal capacity and 75rpm (rotations per minute).
These intervals will be interspersed with 1-min breaks of cycling at low resistance and 75rpm, and the session will conclude with a 3-minute cool-down interval (20 minutes in total).
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実験的：Afternoon First
Participants will complete a single bout of exercise at 16:00, and after at least a one-week washout perform another exercise bout at 09:00.
|
The participants will perform a low-volume, High-intensity Intermittent Exercise bout on a cycle ergometer.
Peak exercise capacity of the study participants will be determined on a separate occasion using a ramp-up maximal oxygen consumption test (VO2peak).
A single exercise bout will consist of a 7-minute warm-up on a cycle ergometer, followed by 6 1-minute intervals of cycling at individual maximal capacity and 75rpm (rotations per minute).
These intervals will be interspersed with 1-min breaks of cycling at low resistance and 75rpm, and the session will conclude with a 3-minute cool-down interval (20 minutes in total).
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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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Exercise-induced Changes in 24 Hour Interstitial Glucose Concentration
時間枠：3 days (1 day before to 1 day after exercise)
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Glucose excursions will be charted using continuous interstitial glucose monitors.
The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glycemia.
Exercise effects on glucose concentration will be primarily assessed by comparing 24-hour curves between conditions.
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3 days (1 day before to 1 day after exercise)
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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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Acute Exercise-induced Changes in Interstitial Glucose Concentration
時間枠：2 hours (0 minutes before to 120 minutes after exercise)
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Glucose will be charted using continuous glucose monitors.
Acute response to exercise, during the exercise bout and during an additional 120 minutes will be compared between conditions.
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2 hours (0 minutes before to 120 minutes after exercise)
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Interstitial Glucose Concentration Response to a Meal
時間枠：2 days (1 day before and day of exercise)
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Glucose will be charted using continuous glucose monitors.
Three standardized meals per day will be provided on each occasion for the day before, day of and day after exercise.
The 120 minute glucose response to the standardized meal succeeding an exercise bout will be compared to the same meal on a baseline (no exercise) day and between the two exercise times.
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2 days (1 day before and day of exercise)
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Interstitial Glucose Concentration Variability
時間枠：3 days (1 day before to 1 day after exercise)
|
Glucose will be charted using continuous glucose monitors.
The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glucose concentration variability.
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3 days (1 day before to 1 day after exercise)
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Time Spent in Interstitial Glucose Concentration Range
時間枠：3 days (1 day before to 1 day after exercise)
|
Glucose will be charted using continuous glucose monitors.
The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glycemic variability.
Daily time spent in low (<3.9mmol/L),
high (>10mmol/L) and within target glycemic range (3.9-10mmol/L) will be calculated on each occasion.
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3 days (1 day before to 1 day after exercise)
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Nocturnal Interestitial Glucose Concentration
時間枠：2 days (day of, and 1 day after exercise)
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Glucose will be charted using continuous glucose monitors.
The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glycemic variability.
Nocturnal glycemia (00:00-06:00) for each day will be compared on each exercise occasion.
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2 days (day of, and 1 day after exercise)
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Metabolic Response to Exercise
時間枠：1 hour (5 minutes before, 5 minutes after and 60 minutes after exercise)
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Changes in blood, skeletal muscle and subcutaneous adipose tissue metabolite levels will be assessed by broad-spectrum, untargeted metabolomics.
Samples will be collected immediately before (-5 minutes) and after (+5 minutes) each exercise bout.
An additional blood sample will be collected one hour after exercise completion (+60 minutes).
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1 hour (5 minutes before, 5 minutes after and 60 minutes after exercise)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Harriet Wallberg-Henriksson, MD PhD、Karolinska Institutet
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 (実際)
2021年11月10日
一次修了 (予想される)
2023年11月1日
研究の完了 (予想される)
2023年11月1日
試験登録日
最初に提出
2021年10月19日
QC基準を満たした最初の提出物
2021年11月1日
最初の投稿 (実際)
2021年11月10日
学習記録の更新
投稿された最後の更新 (実際)
2021年11月12日
QC基準を満たした最後の更新が送信されました
2021年11月11日
最終確認日
2021年11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
- HIT Metabolome
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Individual participant data underlying results reported in a publication will be shared after deidentification.
IPD 共有時間枠
Data will be made available indefinetly after publication.
IPD 共有アクセス基準
Data will be available for any purpose.
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米国FDA規制機器製品の研究
いいえ
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