NCT03545841

Brief Summary

Few people with type 1 diabetes achieve exercise guidelines and many programmes designed to increase physical activity have failed. High-intensity interval training (HIT) has been shown to be a time-efficient alternative to traditional moderate-intensity continuous training (MICT) in various groups without type 1 diabetes. A single bout of HIT does not increase the risk of hypoglycaemia in people with type 1 diabetes. This study aimed to assess whether HIT a safe, effective and time-efficient training strategy to improve cardio-metabolic health and reduce the risk of hypoglycaemia in people with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
Last Updated

June 4, 2018

Status Verified

June 1, 2018

Enrollment Period

2.6 years

First QC Date

May 9, 2018

Last Update Submit

June 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximal aerobic capacity

    Maximal aerobic capacity test pre and post 6-week training intervention

    change in baseline maximal aerobic capacity at 6 weeks

Secondary Outcomes (1)

  • Vascular stiffness

    change in baseline vascular stiffness at 6 weeks

Study Arms (2)

HIT training

EXPERIMENTAL

6 weeks of high-intensity interval training (HIT)

Other: HIT

Moderate intensity training

EXPERIMENTAL

6 weeks of moderate-intensity continuous training (MICT)

Other: MICT

Interventions

HITOTHER

Participants completed 6 weeks of HIT

HIT training
MICTOTHER

Participants completed 6 weeks of MICT

Moderate intensity training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • duration of type 1 diabetes \>6 months
  • basal bolus regimen
  • no significant history of hyper- or hypoglycaemia (determined from medical history)

You may not qualify if:

  • duration of type 1 diabetes \<6 months,
  • insulin pump therapy
  • significant history of hyper- or hypoglycaemia (determined from medical history)
  • obesity (BMI \>30 kg∙m-2)
  • pregnancy or planning pregnancy
  • uncontrolled hypertension (\>180/100 mmHg)
  • angina, autonomic neuropathy
  • taking any medication that affects heart rate
  • major surgery planned within 6 weeks of the study
  • severe nonproliferative
  • unstable proliferative retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Sam Shepherd, Principle Investigator

Study Record Dates

First Submitted

May 9, 2018

First Posted

June 4, 2018

Study Start

March 9, 2015

Primary Completion

October 10, 2017

Study Completion

October 10, 2017

Last Updated

June 4, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

No plans to make data available to others

Locations