High-intensity Interval, Low Volume Training in Metabolic Syndrome (Intraining-MET)
Efficacy of High-intensity Interval, Low-volume Training Compared to Continuous Aerobic Exercise on Insulin Resistance, Skeletal Muscle Composition and Endocrine Function in Adults With Metabolic Syndrome: a Randomized Controlled Clinical Trial (Intraining-MET)
The primary objective of the study is to compare the efficacy of an intervention with high-intensity interval, low volume training (HIIT-LV) or continuous aerobic exercise (CAE) on insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function in adults with metabolic syndrome (MS).
The secondary objective is to compare the efficacy of an intervention with HIIT-LV or CAE on glycosylated hemoglobin, mass and muscle fibre type composition of right thigh and plasma levels of musclin and apelin in adults with MS.
The investigators hypothesized that HIIT-LV is more effective in decreasing insulin resistance and glycosylated hemoglobin and plasma concentrations of musclin and increasing plasma concentrations of apelin, and both mass and muscle fibre type I percentage in thigh, than CAE.
調査の概要
詳細な説明
This study is a randomized, controlled, masked (single blind, outcomes assessor) clinical trial, with allocation by the minimization method, with two parallel groups and intention of superiority. It was designed to test the hypothesis that a 12-week program of HIIT-LV, yields larger beneficial effects on insulin resistance, skeletal muscle composition and endocrine function than CAE.
Although aerobic exercise increases cardio-respiratory capacity, modifies risk factors and decreases mortality risk, there is currently controversy and gaps in knowledge over the efficacy of more intense and low-volume physical activities on muscle metabolism in patients with metabolic disorders.
The primary outcome will be the insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function. The secondary outcomes will be the glycosylated hemoglobin, mass and muscle fibre type composition of thigh and plasma levels of musclin and apelin. Assessments will be made before and after the 12-week program. Calculations based on previously results (difference mean 10% and SD 15%) suggest that a total number of 60 patients randomized 1:1 (30 in each group) to the two intervention groups is sufficient to detect larger beneficial effects with HIIT-LV with a p-value of 0.05 (two-sided test) and statistical power of 0.80 (primary endpoint is insulin sensitivity).
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
-
-
Antioquia
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Medellin、Antioquia、コロンビア
- IPS-Universitaria
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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:
- Metabolic syndrome defined according to the International Diabetes Federation-criteria.
- Insulin resistance defined according to the HOMA greater than 2.25
- Sedentary lifestyle (less than 60 min of physical activity per week)
Exclusion Criteria:
- Vegetarian diet
- Vitamin D3 supplementation
- Oral contraceptives
- Musculoskeletal diseases or injuries
- Physical, sensory or cognitive impairment
- History of cardiovascular disease (coronary, cerebrovascular, peripheral arterial disease, uncontrolled cardiac arrhythmias).
- Pulmonary diseases
- Acute or chronic inflammatory conditions
- Cancer
- Human immunodeficiency virus infection
- Diabetes mellitus
- Hyperthyroidism
- Pregnancy
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：処理
- 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 |
|---|---|
|
実験的：1x2 HIIT-LV, 3 times a week, 24 min
|
Supervised endurance treadmill training as walking/running "uphill", 3 times/week during 12 weeks starting at 85-90% of previously determined maximum oxygen consumption (VO2 max).
Warm-up 3 min at 30% of VO2 max, 3 min cool-down.
Progression in intensity every 3erd week.
|
|
アクティブコンパレータ：CAE, moderate intensity, 3 times a week, 36 min
|
Supervised moderate intensity treadmill training, 3 times/week for 12 weeks starting at 70% of VO2 max.
Warm-up 3 min at 30% of VO2 max, 3 min cool-down.
Progression in intensity every 3erd week.
|
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 |
|---|---|---|
|
Insulin sensitivity
時間枠：12-week
|
Using HOMA model (units as percentages of a normal reference population)
|
12-week
|
|
Insulin resistance
時間枠：12-week
|
Using HOMA model (arbitrary units)
|
12-week
|
|
Pancreatic β-cell function
時間枠：12-week
|
Using HOMA model (units as percentages of a normal reference population)
|
12-week
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Glycosylated hemoglobin
時間枠：12-week
|
Using blood tests (%)
|
12-week
|
|
Mass muscle of right thigh
時間枠：12-week
|
Using dual energy x-ray absorptiometry (DEXA) (kg/m2)
|
12-week
|
|
Muscle fibre type composition of right thigh
時間枠：12-week
|
Using carnosine quantification by hydrogen magnetic resonance spectroscopy (1H-MRS) (% fibre type I)
|
12-week
|
|
Musclin
時間枠：12-week
|
Using plasma levels of musclin (pg/mL)
|
12-week
|
|
Apelin
時間枠：12-week
|
Using plasma levels of apelin (pg/mL)
|
12-week
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Juan Calderón, MD, PhD、Professor
- スタディディレクター：Daniel Aguirre, PhD、Professor
出版物と役立つリンク
一般刊行物
- Gallo-Villegas J, Restrepo D, Perez L, Castro-Valencia LA, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Safety of High-Intensity, Low-Volume Interval Training or Continuous Aerobic Training in Adults With Metabolic Syndrome. J Patient Saf. 2022 Jun 1;18(4):295-301. doi: 10.1097/PTS.0000000000000922. Epub 2021 Sep 20.
- Aristizabal JC, Montoya E, Sanchez YL, Yepes-Calderon M, Narvaez-Sanchez R, Gallo-Villegas JA, Calderon JC. Effects of Low-Volume, High-Intensity Interval Training Compared with Continuous Training on Regional and Global Body Composition in Adults with Metabolic Syndrome: A post hoc Analysis of a Randomized Clinical Trial. Ann Nutr Metab. 2021;77(5):279-288. doi: 10.1159/000518909. Epub 2021 Oct 6.
- Gallo-Villegas J, Castro-Valencia LA, Perez L, Restrepo D, Guerrero O, Cardona S, Sanchez YL, Yepes-Calderon M, Valbuena LH, Pena M, Milan AF, Trillos-Almanza MC, Granados S, Aristizabal JC, Estrada-Castrillon M, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Efficacy of high-intensity interval- or continuous aerobic-training on insulin resistance and muscle function in adults with metabolic syndrome: a clinical trial. Eur J Appl Physiol. 2022 Feb;122(2):331-344. doi: 10.1007/s00421-021-04835-w. Epub 2021 Oct 23.
- Gallo-Villegas J, Aristizabal JC, Estrada M, Valbuena LH, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET). Trials. 2018 Feb 27;19(1):144. doi: 10.1186/s13063-018-2541-7.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
その他の研究ID番号
- 54-2016
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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