- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07565935
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Oluwaseun Anyiam
- Telefonnummer: +441332724605
- E-post: oluwaseun.anyiam1@nottingham.ac.uk
Studieorter
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Derby, Storbritannien, DE22 3DT
- University of Nottingham, Royal Derby Hospital Centre
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Kontakt:
- Iskandar Idris
- Telefonnummer: +441332724605
- E-post: iskandar.idris@nottingham.ac.uk
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pancreatic beta cell function
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Insulin sensitivity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Iskandar Idris, University of Nottingham
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Näringsstörningar
- Metaboliska sjukdomar
- Övernäring
- Kroppsvikt
- Störningar i glukosmetabolism
- Diabetes mellitus
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Tecken och symtom
- Övervikt
- Fetma
- Diabetes mellitus, typ 2
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Utöva
Andra studie-ID-nummer
- 24057
Plan för individuella deltagardata (IPD)
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