Acute Exercise and Free-living Glycaemic Control in Type 2 Diabetes

NCT03082859 | Unknown

• 1 other identifier: 16/NI/0115
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise is considered one of the three cornerstones of type 2 diabetes (T2D) care programmes (together with diet and medication), yet the majority of individuals with T2D do not achieve the minimum recommended levels of physical activity. Two of the key barriers to exercise appear to be a 'lack of time' and the high levels of perceived exertion and fatigue. At Ulster University, it has recently been demonstrated that a modified high-intensity interval training (HIT) intervention, consisting of 10-min of low-intensity cycling interspersed with two 20-s 'all-out' sprints (reduced-exertion HIT; REHIT), was effective at improving insulin sensitivity in sedentary men over six weeks. Importantly, these benefits were observed despite the very low time commitment (just 10-min per session) and relatively low ratings of perceived exertion ('somewhat hard'). As REHIT is associated with substantial muscle glycogen breakdown, we hypothesise that this exercise mode may also acutely improve glycaemic control in patients with T2D. This study will:

1. 1.Examine the acute impact of REHIT, compared with a no-exercise control, on 24-hour glycaemic control under dietary-controlled but otherwise 'free-living' conditions using continuous glucose monitoring.
2. 2.Compare the effects of REHIT with currently recommended levels of aerobic exercise and a previously recommended HIT model, both of which have been shown to improve 24-hour glycaemic control in T2D.
3. 3.Collect information on individual's perceptions of each exercise mode through measures of affect, motivation, perceived exertion, fatigue, enjoyment and attentional focus.

Conditions

Type 2 Diabetes

Keywords

Exercise; Interval Training; Glycaemic Control; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean 24-hour blood glucose concentrations (mmol/L)

  24-hour glucose levels will be measured with continuous glucose monitors under standard dietary conditions. Mean blood glucose (mmol/L) will be calculated.

  24-hours

Secondary Outcomes (3)

• Time spent in hyperglycaemia (% of 24-h day)

  24-hours

• Incremental Area Under the Curve (AUC)

  24 Hours

• Glycaemic Variability (Glucose levels)

  24-hours

Other Outcomes (6)

• Ratings of perceived exertion (RPE) (Borg Scale)

  1 Hour

• Exercise Enjoyment assessed using the exercise enjoyment scale

  30 minutes

• Perceptions of physical tiredness and fatigue assessed using 100-mm visual analogue scale

  1 Hour

Study Arms (4)

Reduced-exertion high-intensity interval training

EXPERIMENTAL

Cycling Exercise. 2 x 20-sec sprints.

Behavioral: Exercise

High Intensity Interval Training (HIT)

EXPERIMENTAL

Cycling Exercise. 10 x 1 min at approx 85% peak power output (Wmax)

Behavioral: Exercise

Moderate Intensity Continuous Exercise

EXPERIMENTAL

Cycling exercise. 30 min at 50% peak power output (Wmax)

Behavioral: Exercise

Sedentary (no exercise)

NO INTERVENTION

No exercise. Rest.

Interventions

Exercise BEHAVIORAL

This a randomised cross-over study involving three different modes of exercise which will be compared to a no-exercise control.

High Intensity Interval Training (HIT); Moderate Intensity Continuous Exercise; Reduced-exertion high-intensity interval training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• year-old men who have been diagnosed with Type 2 diabetes by a clinician at least 3 months prior to the start of the study according to standard criteria.
• Able and willing to safely comply with all study procedures.
• Able to provide written informed consent whilst acknowledging their freedom to withdraw at any point during the study.
• Inactive or moderately physically active according to the International Physical Activity Questionnaire.

You may not qualify if:

• Aged \< 18 years or \> 60 years
• Female
• Insulin therapy
• Use of more than two antidiabetic drugs
• Use of βblockers
• Use of inhaled steroids (e.g. for asthma)
• Any cardiovascular condition with the exception of well-controlled uncomplicated hypertension (systolic \>160 mmHg and/or \>90mmHg after at least 5 min of seated rest), which is treated with no more than two drugs (either an ACE, ARB, calcium channel blocker, or diuretic)
• Cerebrovascular disease including previous stroke or aneurysm
• History of exercise-induced asthma
• History of Type 1 diabetes mellitus or a history of ketoacidosis
• History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug or chemical-induced, and post organ transplant)
• Any prior history of malignancy with the exception of: basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has been recurrence free for 5 years, other malignancies (regardless of site) that have been recurrence free for 10 years.
• History of respiratory disease including pulmonary hypertension or chronic obstructive pulmonary disease
• History of musculoskeletal or neurological disorders
• Active inflammatory bowel disease

Sponsors & Collaborators

• University of Ulster: lead
• Diabetes Research and Wellness Foundation: collaborator

Study Sites (1)

Ulster University

Londonderry, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Richard S Metcalfe, PhD

  Lecturer in Exercise and Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard S Metcalfe, PhD

CONTACT

028 716 75037; r.metcalfe@ulster.ac.uk

Study Design

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

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: March 17, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 17, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)