HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)

NCT ID: NCT03598400

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-08-01

Brief Summary

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There is clear evidence that regular exercise improves wellbeing and reduces the risk of diabetes related complications in people with type 1 diabetes. However, many people with type 1 diabetes do not exercise regularly. The primary reason for this is fear of hypoglycaemia and loss of glycaemic control associated with exercise. This loss of glycaemic control is associated with traditional moderate intensity continous aerobic exercise advocated in the guidelines for exercise in people with type 1 diabetes. Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is needed before firm conclusions can be drawn.

Therefore, the aim of this study is to determine the effects of HIT on glycaemic control in people with type 1 diabetes compared to no exercise and traditional moderate intensity continous exercise.

24 people with type 1 diabetes will be recruited to complete a randomised counterbalanced cross over study comparing 3x 2-week interventions periods. During these intervention periods participant will maintain their habitual lifestyle but complete either no exercise (control), traditional moderate intensity continous exercise or high intensity interval training. Throughout the intervention periods participants glycaemic control will be monitored using a flash glucose monitor.

Detailed Description

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Conditions

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Type1diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Participants will continue with their habitual lifestyle but perform no exercise for 2 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Moderate intensity continous training

Participants will complete moderate intensity continous training during a 2 week intervention period

Group Type ACTIVE_COMPARATOR

moderate intensity continous training

Intervention Type BEHAVIORAL

Participants will complete 6 sessions of moderate intensity continous training during a 2 week intervention period. Participants will be asked to complete 30 minutes of continuous exercise.

high intensity interval training

Participants will complete high intensity interval training during a 2 week intervention period

Group Type EXPERIMENTAL

high intensity interval training

Intervention Type BEHAVIORAL

Participants will complete 6 sessions of high intensity interval training during a 2 week intervention period. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest.

Interventions

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high intensity interval training

Participants will complete 6 sessions of high intensity interval training during a 2 week intervention period. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest.

Intervention Type BEHAVIORAL

moderate intensity continous training

Participants will complete 6 sessions of moderate intensity continous training during a 2 week intervention period. Participants will be asked to complete 30 minutes of continuous exercise.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* T1D diagnosis more than 6 months ago (to ensure participants are out of the honeymoon period),
* Using a basal bolus insulin regime or insulin pump therapy
* BMI ≤ 32 kg.m-2

Exclusion Criteria

* Pregnancy (or planning pregnancy)
* Disability preventing participation in an exercise regime
* Angina
* Autonomic neuropathy
* Medication that affects heart rate (this will affect estimation of fitness)
* Major surgery planned within 6 weeks of study
* Uncontrolled blood pressure
* Significant history of hyperglycaemia
* History of severe hypoglycaemia requiring third party assistance within the last 3 months
* Severe non-proliferative and unstable proliferative retinopathy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Society for Endocrinology

OTHER

Sponsor Role collaborator

Royal Liverpool University Hospital

OTHER_GOV

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role collaborator

Liverpool John Moores University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Liverpool John Moores University

Liverpool, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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T1D1

Identifier Type: -

Identifier Source: org_study_id

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