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Effects of HIIT Following PTR Programme (HIITpostLCD)

29. april 2026 oppdatert av: University of Nottingham

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Atferdsmessig: Exercise
High-intensity interval training
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pancreatic beta cell function
Tidsramme: Assessed at baseline and then follow-up (16 weeks)
Assessment of beta-cell function using insulin first phase response from an intravenous glucose tolerance test
Assessed at baseline and then follow-up (16 weeks)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Insulin sensitivity
Tidsramme: Assessed at baseline and then follow-up (16 weeks)
Measured during the intravenous glucose tolerance test (IVGTT) and calculated from fasting glucose and insulin using the homeostatic model of assessment for insulin resistance
Assessed at baseline and then follow-up (16 weeks)
Overall glycaemic control
Tidsramme: Assessed at baseline and then follow-up (16 weeks)
From measurement of glycated haemoglobin (HbA1c)
Assessed at baseline and then follow-up (16 weeks)
Body weight
Tidsramme: Assessed at baseline and then follow-up (16 weeks)
Measurement of participant weight
Assessed at baseline and then follow-up (16 weeks)
Body composition
Tidsramme: Assessed at baseline and then follow-up (16 weeks)
Measurement of fat mass and fat-free mass using bioimpedance analysis
Assessed at baseline and then follow-up (16 weeks)
Skeletal muscle function
Tidsramme: Assessed at baseline and then follow-up (16 weeks)
Assessed using muscle strength (1 repetition maximum) testing and electromyography
Assessed at baseline and then follow-up (16 weeks)
Skeletal muscle structure
Tidsramme: Assessed at baseline and then follow-up (16 weeks)
Using muscle ultrasonography to assess muscle thickness, cross sectional area and fibre pennation angle
Assessed at baseline and then follow-up (16 weeks)
Cardiorespiratory fitness
Tidsramme: Assessed at baseline and then follow-up (16 weeks)
Determined from be the highest rate of oxygen consumption obtained (VO2max) during a cardiopulmonary exercise test
Assessed at baseline and then follow-up (16 weeks)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Nottingham

Samarbeidspartnere

Association of British Clinical Diabetologists

Etterforskere

  • Hovedetterforsker: Iskandar Idris, University of Nottingham

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

24. mars 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2026

Sist bekreftet

1. mars 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 24057

Plan for individuelle deltakerdata (IPD)

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Nei

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