Effects of HIIT Following PTR Programme (HIITpostLCD)
Can High-Intensity Interval Training (HIIT) Reduce the Risk of Diabetes Relapse Following Discharge From the NHS Path to Remission Programme? - a Pilot Study
Caloric restriction programmes are highly effective and safe interventions for inducing rapid weight loss and improvements in glycaemic control. The landmark DiRECT study showed that 68% of people completing a caloric restriction intervention achieved remission of type 2 diabetes (T2D) by one year. Consequently, the NHS Path to Remission (PTR) programme was developed to stimulate diabetes remission in individuals that meet certain criteria. Unfortunately, long-term follow-up of the DiRECT study suggests that in the majority of participants that achieved remission, diabetes relapses within 5 years. This necessitates a focus on identifying methods to improve long-term maintenance of diabetes remission.
High-intensity interval training (HIIT) involves several brief bursts of intense exercise, interspersed with recovery breaks, and is becoming increasingly popular. HIIT can cause improvements in cardiovascular fitness, reduce blood pressure, and lower body fat content in only a fraction of the time of traditional exercise methods. Specific to T2D, HIIT has been shown to improve pancreatic beta cell function, which is critically important for maintenance of long-term diabetes remission.
This pilot study is being conducted to determine whether participating in a home-based HIIT training programme may help maintain beta cell function in individuals that have achieved diabetes remission following the NHS PTR programme. The study will take place at the Royal Derby Hospital.
The intention is to recruit 20 participants from Derbyshire or Nottinghamshire that have achieved diabetes remission in the NHS PTR programme. Participants will be recruited following discharge from the programme and allocated to either perform a HIIT training programme (intervention group), or continue with usual care (control group) for 16 weeks.
Before starting, participants will attend the research department to have initial measurements taken including bioimpedance, fasting bloods, an intravenous glucose tolerance test, muscle ultrasound, electromyography and cardiopulmonary exercise testing. Following this, those in the intervention group will be asked to perform a home-based HIIT training programme 3 times per week and record details of each session in a booklet. The control group will be asked to continue with their habitual levels of physical activity. Participants will be contacted regularly to ensure their safety and compliance.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Oluwaseun Anyiam
- 電話番号:+441332724605
- メール:oluwaseun.anyiam1@nottingham.ac.uk
研究場所
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Derby、イギリス、DE22 3DT
- University of Nottingham, Royal Derby Hospital Centre
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コンタクト:
- Iskandar Idris
- 電話番号:+441332724605
- メール:iskandar.idris@nottingham.ac.uk
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults between the age of 18-70 years
- Ability to provide informed consent
- Completed the NHS Path to Remission programme and achieved diabetes remission (HbA1c <48mmol/mol (6.5%), and off diabetes medications for at least three months)
Exclusion Criteria:
- BMI > 40kg/m2
- Current participation in a formal exercise regime
- Current pregnancy or breastfeeding
- Uncontrolled hypertension (blood pressure >160/100mmHg)
History of cardiovascular disease:
- Symptomatic angina
- Heart failure (class III/IV)
- Significant arrhythmias
- Right to left cardiac shunt
- Recent acute coronary syndrome
- Severe aortic valvular disease
- Active cardiac infection
Background of the following respiratory diseases:
- Pulmonary hypertension
- Significant COPD
- Uncontrolled asthma
- History of malignancy undergoing current treatment or palliation
- Presence of significant musculoskeletal, neurological or cerebrovascular disease
- Any other medical condition deemed by the investigators to preclude inclusion into the study
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- 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 |
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実験的:HIIT group
This group will perform 16 weeks of high-intensity interval training.
This will involve performing a 15-minute routine, three times a week.
The exercise programme includes star jumps, standing squats, on-the-spot sprints, then repeating standing squats and star jumps again (this pyramid design has been chosen as it can be used to provide participants with a target of repetitions to achieve in the 4th and 5th interval).
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High-intensity interval training
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介入なし:Control group
This is the control group and will be asked to perform their usual habitual levels of activity for the 16 weeks of the study.
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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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Pancreatic beta cell function
時間枠:Assessed at baseline and then follow-up (16 weeks)
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Assessment of beta-cell function using insulin first phase response from an intravenous glucose tolerance test
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Assessed at baseline and then follow-up (16 weeks)
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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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Insulin sensitivity
時間枠:Assessed at baseline and then follow-up (16 weeks)
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Measured during the intravenous glucose tolerance test (IVGTT) and calculated from fasting glucose and insulin using the homeostatic model of assessment for insulin resistance
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Assessed at baseline and then follow-up (16 weeks)
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Overall glycaemic control
時間枠:Assessed at baseline and then follow-up (16 weeks)
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From measurement of glycated haemoglobin (HbA1c)
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Assessed at baseline and then follow-up (16 weeks)
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Body weight
時間枠:Assessed at baseline and then follow-up (16 weeks)
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Measurement of participant weight
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Assessed at baseline and then follow-up (16 weeks)
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Body composition
時間枠:Assessed at baseline and then follow-up (16 weeks)
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Measurement of fat mass and fat-free mass using bioimpedance analysis
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Assessed at baseline and then follow-up (16 weeks)
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Skeletal muscle function
時間枠:Assessed at baseline and then follow-up (16 weeks)
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Assessed using muscle strength (1 repetition maximum) testing and electromyography
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Assessed at baseline and then follow-up (16 weeks)
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Skeletal muscle structure
時間枠:Assessed at baseline and then follow-up (16 weeks)
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Using muscle ultrasonography to assess muscle thickness, cross sectional area and fibre pennation angle
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Assessed at baseline and then follow-up (16 weeks)
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Cardiorespiratory fitness
時間枠:Assessed at baseline and then follow-up (16 weeks)
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Determined from be the highest rate of oxygen consumption obtained (VO2max) during a cardiopulmonary exercise test
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Assessed at baseline and then follow-up (16 weeks)
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Iskandar Idris、University of Nottingham
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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。