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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03545841
Other study ID # T1D_PARTB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2015
Est. completion date October 10, 2017

Study information

Verified date June 2018
Source Liverpool John Moores University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study aimed to investigate whether 1) six weeks of high-intensity interval training (HIT) induces similar improvements in cardio-metabolic health markers as moderate-intensity continuous training (MICT) in people with type 1 diabetes, and 2) whether HIT abolishes acute reductions in plasma glucose observed following MICT sessions. Fourteen sedentary individuals with type 1 diabetes (n=7 per group) completed six weeks of HIT or MICT 3 times per week. Pre- and post-training measurements were made of 24h interstitial glucose profiles (using continuous glucose monitors (CGMS)) and cardio-metabolic health markers (V ̇O2peak, blood lipid profile and aortic pulse wave velocity; aPWV). Capillary blood glucose concentrations were assessed before and after exercise sessions throughout the training programme to investigate changes in blood glucose during exercise in the fed state.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date October 10, 2017
Est. primary completion date October 10, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- duration of type 1 diabetes >6 months

- basal bolus regimen

- no significant history of hyper- or hypoglycaemia (determined from medical history)

Exclusion Criteria:

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

Study Design


Intervention

Other:
HIT
Participants completed 6 weeks of HIT
MICT
Participants completed 6 weeks of MICT

Locations

Country Name City State
United Kingdom Liverpool John Moores University Liverpool Merseyside

Sponsors (1)

Lead Sponsor Collaborator
Liverpool John Moores University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal aerobic capacity Maximal aerobic capacity test pre and post 6-week training intervention change in baseline maximal aerobic capacity at 6 weeks
Secondary Vascular stiffness Aortic pulse wave velocity to measure vascular stiffness change in baseline vascular stiffness at 6 weeks
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