Determining the Minimal Amount of Exercise to Improve Glycaemic Control

NCT04129268 | Completed

• 2 other identifiers: 24831919/NW/0066
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

In 2015, there were 415 million adults worldwide with type II diabetes and by 2040, typeII diabetes will affect one in ten adults worldwide. Type II diabetes reduces quality of life and total lifespan, and two of the best countermeasures to type II diabetes are not drugs, but diet and exercise. Several studies have investigated the effects of exercise modality (aerobic, resistance, or concurrent) on glycaemic control and the mechanisms of these benefits. However, the minimal 'dose' of exercise required to increase insulin sensitivity and improve glycaemic control has never been established. Secondly, there is a progressive loss of muscle structure and function with age, which is known as sarcopenia. This study will also investigate whether the minimal amount of exercise is influenced by biological age and muscle mass by comparing physiological and biochemical responses in BMI-matched young and old volunteers. This study will therefore provide pilot data on the effect of age on exercise-mediated glycaemic control.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Lowering of blood glucose values throughout the two-hour oral glucose tolerance test (OGTT) measured every 30 minutes throughout from an arterialised-venous hand vein 24 hours following large (700kcal) in comparison to small (175kcal) exercise quantities

  The investigators will quantify the lowering of blood glucose values during the OGTT 24h following 175kcal, 350kcal and 700kcal exercise when compared to a no exercise control.

  over the 8 weeks of participant involvement in study

Secondary Outcomes (1)

• Lowering of serum insulin values throughout the two-hour oral glucose tolerance test (OGTT) measured every 30 minutes throughout from an arterialised-venous hand vein 24 hours following large (700kcal) in comparison to small (175kcal) exercise quantities

  over the 8 weeks of participant involvement in study

Study Arms (4)

No exercise control

OTHER

The investigators will use a randomised, crossover design study, where all subjects will complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; and (iv) 700kcal exercise on a cycle ergometer the day before an oral glucose tolerance test (OGTT). 350kcal has previously been shown to improve control of blood glucose when an OGTT is competed 24 h after the cycle ergometry exercise. The investigators have therefore chosen half this amount (175kcal) and double this amount (700kcal) to try and stimulate the greatest (700kcal) and least (175kcal) improvements in glycaemic control compared to no exercise. The investigators are, in essence, calculating a dose-response curve for quantity of exercise ((i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; and (iv) 700kcal exercise on a cycle ergometer) on the x axis and improvement in glycaemic control on the y axis.

Other: Cycle ergometry exercise at 60% VO2max

175kcal Cycle ergometry exercise at 60% VO2max

EXPERIMENTAL

The investigators will use a randomised, crossover design study, where all subjects will complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; and (iv) 700kcal exercise on a cycle ergometer the day before an oral glucose tolerance test (OGTT). 350kcal has previously been shown to improve control of blood glucose when an OGTT is competed 24 h after the cycle ergometry exercise. The investigators have therefore chosen half this amount (175kcal) and double this amount (700kcal) to try and stimulate the greatest (700kcal) and least (175kcal) improvements in glycaemic control compared to no exercise. The investigators are, in essence, calculating a dose-response curve for quantity of exercise ((i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; and (iv) 700kcal exercise on a cycle ergometer) on the x axis and improvement in glycaemic control on the y axis.

Other: Cycle ergometry exercise at 60% VO2max

350kcal Cycle ergometry exercise at 60% VO2max

EXPERIMENTAL

The investigators will use a randomised, crossover design study, where all subjects will complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; and (iv) 700kcal exercise on a cycle ergometer the day before an oral glucose tolerance test (OGTT). 350kcal has previously been shown to improve control of blood glucose when an OGTT is competed 24 h after the cycle ergometry exercise. The investigators have therefore chosen half this amount (175kcal) and double this amount (700kcal) to try and stimulate the greatest (700kcal) and least (175kcal) improvements in glycaemic control compared to no exercise. The investigators are, in essence, calculating a dose-response curve for quantity of exercise ((i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; and (iv) 700kcal exercise on a cycle ergometer) on the x axis and improvement in glycaemic control on the y axis.

Other: Cycle ergometry exercise at 60% VO2max

700kcal Cycle ergometry exercise at 60% VO2max

EXPERIMENTAL

The investigators will use a randomised, crossover design study, where all subjects will complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; and (iv) 700kcal exercise on a cycle ergometer the day before an oral glucose tolerance test (OGTT). 350kcal has previously been shown to improve control of blood glucose when an OGTT is competed 24 h after the cycle ergometry exercise. The investigators have therefore chosen half this amount (175kcal) and double this amount (700kcal) to try and stimulate the greatest (700kcal) and least (175kcal) improvements in glycaemic control compared to no exercise. The investigators are, in essence, calculating a dose-response curve for quantity of exercise ((i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; and (iv) 700kcal exercise on a cycle ergometer) on the x axis and improvement in glycaemic control on the y axis.

Other: Cycle ergometry exercise at 60% VO2max

Interventions

Cycle ergometry exercise at 60% VO2max OTHER

Participants visit the lab on four occasions to complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; (iv) or 700kcal exercise (randomised).

175kcal Cycle ergometry exercise at 60% VO2max; 350kcal Cycle ergometry exercise at 60% VO2max; 700kcal Cycle ergometry exercise at 60% VO2max; No exercise control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and upwards
• Capacity to consent to participation
• Diagnosis of type II diabetes
• BMI \>25

You may not qualify if:

• Patient is aged under 18 years
• Patient lacks capacity to consent to participation
• Anything that investigators feel affects the study measurements or safety
• Cohort 2: 9 young control subjects under the following criteria:
• Aged 18 - 40
• Capacity to consent to participation
• BMI \>25
• Subject is aged under 18 years
• Subject lacks capacity to consent to participation
• Subject on medication that affects glycaemic control
• Anything that investigators feel affects the study measurements or safety
• Cohort 3: 9 older control subjects under the following criteria:
• Aged \>60
• Capacity to consent to participation
• BMI \>25

Sponsors & Collaborators

• Lancaster University: lead

Study Sites (1)

Royal Lancaster Infirmary

Lancaster, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Lecturer in Sports Science

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 16, 2019
• Study Start: October 1, 2019
• Primary Completion: September 26, 2022
• Study Completion: September 29, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)