Optimisation of Exercise Intensity During High-Intensity Interval Training for Glucose Control in Prediabetes

NCT04256005 | Completed

• 1 other identifier: AU/IBERS/003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to identify the optimal exercise intensity of the high-intensity phase during a bout of High-Intensity Interval Training (HIIT) to increase glucose clearance in a prediabetic population. The study is a within-subjects randomised crossover design with participants attending the laboratory on seven occasions over a two week period. The first visit will be to perform medical screening and to obtain informed consent. The second visit will be to collect baseline measures, select meal plans, to collect an activity tracker and to complete a ramped exercise test to establish exercise intensity thresholds. The third visit will be to fit an interstitial glucose sensor and to collect the standardised meals which will be provided to each participant. Visits four, five, and six will be the experimental trials. The seventh visit will be to remove the interstitial glucose sensor and return the activity tracker.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve following first Carbohydrate load measured by continuous glucose monitoring

  The area under the curve will be calculated for two hours, six hours, 12 hours and 24 hours following the fist carbohydrate load, the results will be compared between conditions.

  Changes between baseline and two hours, baseline and six hours, baseline and 12 hours and baseline and 24 hours, for each condition.

• Area Under the Curve following second Carbohydrate load measured by continuous glucose monitoring

  The area under the curve will be calculated two hours following the second carbohydrate load, the results will be compared between conditions.

  Changes between baseline and two hours for each condition.

Secondary Outcomes (4)

• Changes in insulin response to exercise assessed by blood sample

  Between five and eight weeks (for the duration of the study).

• Changes in lactate response to exercise assessed by blood sample

  Between five and eight weeks (for the duration of the study).

• Changes in lipid response to exercise assessed by blood sample

  Between five and eight weeks (for the duration of the study).

• Mean Heart Rate (HR) during the exercise trials

  Between five and eight weeks (for the duration of the study).

Study Arms (3)

Control

NO INTERVENTION

Participants will attend the laboratory and complete no exercise. The participants will remain seated for the 29 minutes of the session.

105% VO2Peak

EXPERIMENTAL

Participants will complete ten intervals at a work rate which equates to 105% VO2peak with a 1:1 work rest ratio. The recovery period will involve free cycling against no resistance. The duration of the interval and recovery periods will vary between trials so that the total work done during each trial, excluding CON, will be the same, the duration of intervals will be determined by the 50% ∆ trial which will be set at 60 s for work and recovery intervals.

Other: Exercise

50% ∆ Gas Exchange Threshold

EXPERIMENTAL

Participants will complete ten intervals at a work rate which equates to 50% ∆ GET with a 1:1 work rest ratio. The recovery period will involve free cycling against no resistance. The duration of the interval and recovery periods will vary between trials so that the total work done during each trial, excluding CON, will be the same, the duration of intervals will be determined by the 50% ∆ trial which will be set at 60 s for work and recovery intervals.

Other: Exercise

Interventions

Exercise OTHER

Participants will complete one of two exercise conditions (50% Delta GET or 105% VO2peak).

105% VO2Peak; 50% ∆ Gas Exchange Threshold

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males
• Aged 18 years and over
• Diagnosed with prediabetes within the last 12-months (HbA1c of between 42 and 47 mmol·mol-1)
• Inactive, participating in less than 30-minutes of moderate activity on three days of the week, over the previous three months
• Mental capacity to understand the study purpose and give informed consent to participate

You may not qualify if:

• Existing cardiovascular or respiratory disease, or if the individual has any symptoms or signs of cardiovascular disease:
• pain, discomfort in the chest, neck, jaw, arms, or other areas that may result from ischaemia
• shortness of breath at rest or with mild exertion
• dizziness or syncope
• orthopnea or paroxysmal nocturnal dyspnea
• ankle edema
• palpitations or tachycardia
• intermittent claudication
• known heart murmur
• unusual fatigue or shortness of breath with usual activities
• Any musculoskeletal conditions/injuries which could be exacerbated by exercise.

Sponsors & Collaborators

• Aberystwyth University: lead
• Hywel Dda Health Board: collaborator

Study Sites (1)

Carwyn James Building

Aberystwyth, Ceredigion, SY23 3FD, United Kingdom

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Cerin L Brain, BSc

  Aberystwyth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will perform each of the three different conditions once over the duration of the study. The experimental conditions will be performed in random order, determined by WinPepi for Windows, with each of the experimental trials being separated by five days. The three conditions are; completing ten intervals at a work rate which equates to 105% of VO2peak with a 1:1 work rest ratio, completing ten intervals at a work rate which equates to 50% ∆ GET, with a 1:1 work rest ratio, and a Control (CON) session with no exercise.

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: June 1, 2021
• Primary Completion: November 25, 2021
• Study Completion: December 25, 2021
• Last Updated: February 22, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)