HIT in People With Type 1 Diabetes | NCT03545841

Studies
HIT in People With Type 1 Diabetes

NCT03545841

Sponsor

Liverpool John Moores University

Status

Completed

Last Update Posted

Jun 4, 2018Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Type1diabetes

Interventions

HIT
MICT

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2015Actual

Primary Completion Date

Oct 10, 2017Actual

Completion Date

Oct 10, 2017Actual

First Submitted Date

May 9, 2018

First Submission Date that Met QC Criteria

Jun 1, 2018

First Posted Date

Jun 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2018

Last Update Posted Date

Jun 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sam Shepherd, Dr Sam Shepherd, Principle Investigator, Liverpool John Moores UniversityPrincipal Investigator

Lead Sponsor

Liverpool John Moores UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
HIT	Other	Participants completed 6 weeks of HIT	HIT training
MICT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Vascular stiffness	Aortic pulse wave velocity to measure vascular stiffness	change in baseline vascular stiffness at 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liverpool John Moores University		Liverpool	Merseyside	L3 3AF	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

No plans to make data available to others

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided