HIT on Hypoglycaemic Risk in T1D

NCT05044442 | Completed

• 1 other identifier: SB_T1D_V1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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 Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• Severe hypoglycaemia (using continuous glucose monitoring)

  Number of severe hypoglycaemic events (\<3mmol/l) during the 2 week intervention period

  Over a 2 week intervention period

Secondary Outcomes (8)

• Mean glucose (using continuous glucose monitoring)

  Over a 2 week intervention period

• % of time in level 2 hypoglycaemia (<3.0mmol/L) (using continuous glucose monitoring)

  Over a 2 week intervention period

• % of time in level 1 hypoglycaemia (3.0-3.9mmol/L) (using continuous glucose monitoring)

  Over a 2 week intervention period

• % of time in target range (3.9-10.0mmol/L) (using continuous glucose monitoring)

  Over a 2 week intervention period

• % of time in level 1 hyperglycaemia (10.0-13.9mmol/L) (using continuous glucose monitoring)

  Over a 2 week intervention period

Study Arms (3)

Control

NO INTERVENTION

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

Moderate intensity continous training

ACTIVE COMPARATOR

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

Behavioral: moderate intensity continous training

high intensity interval training

EXPERIMENTAL

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

Behavioral: high intensity interval training

Interventions

moderate intensity continous training 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.

Moderate intensity continous training

high intensity interval training 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.

high intensity interval training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• T1D diagnosis more than 6 months ago
• Using a basal bolus insulin regime or insulin pump therapy
• BMI ≤ 32 kg.m-2

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Society for Endocrinology: collaborator
• Royal Liverpool University Hospital: collaborator
• University of Birmingham: collaborator
• University of Exeter: collaborator

Study Sites (1)

Matthew Cocks

Liverpool, L33AF, United Kingdom

Location

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer/Senior Lecturer, Principle Investigator

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: September 14, 2021
• Study Start: October 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)