Exploring the risks and benefits of exercise in adults with type 1 diabetes

Exploring the risks and benefits of exercise in adults with type 1 diabetes: a ‘real world’ study of patients with type 1 diabetes undertaking the Swansea Half Marathon

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10362196

Enrollment

Registered

2018-05-26

Start date

2018-05-01

Completion date

Unknown

Last updated

2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

Following enrolment and informed consent, participants will be required to undertake a series of tests. These tests will be undertaken at two time points – 6-8 weeks before and 1 week before the half-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Type 1 diabetes (as defined by treatment with insulin) 3. Plan to participate in Swansea Half Marathon and eligible for participation (https://race-nation.com/jcp-swansea-half-marathon-2018)

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Frequency of hypoglycaemia and percentage of time spent in low and high blood glucose levels during the 6 weeks of training. This will be purely descriptive and will be calculated from the continuous glucose monitors. 2. Frequency of hypoglycaemia and percentage of time spent in low and high blood glucose levels on the day of the race and for the 2 weeks after. This will be purely descriptive, and again will be calculated from the continuous glucose monitors. 3. Change in frequency of hypoglycaemia and percentage of time spent in low and high blood glucose levels between week 1 and week 6 (effect of training). This will be calculated from the continuous glucose monitors. These will be compared using a paired T test or a non-parametric Wilcoxon test if the change scores are not normally distributed. In a previous study that we have done, the mean and SD of frequency of hypoglycaemia and percentage of time spent in low and high blood glucose levels were 18.2 + 2.8 hypoglycaemic episodes (hypos) per week, 6.8 + 1.9% of time in low blood glucose levels and 33.7 + 5.4% in high blood glucose levels. This means with a 100 and 50 people respectively we would have the power to detect a 0.78 or 1.2 difference in hypos per week, a 0.5% or 0.8% difference in time spent in low blood glucose level and 1.5% and 2.2% difference in time in high blood glucose levels. 4. Collation of different strategies used by the different participants to manage their T1D during training for and whilst completing a half marathon. This will be purely descriptive and we be grouped into changes in carbohydrate and protein intake, changes in insulin dosages and the combination of both. This will be collected from the questionnaires and patient diary.	—

Measure

Time frame

1. Frequency of hypoglycaemia and percentage of time spent in low and high blood glucose levels during the 6 weeks of training. This will be purely descriptive and will be calculated from the continuous glucose monitors. 2. Frequency of hypoglycaemia and percentage of time spent in low and high blood glucose levels on the day of the race and for the 2 weeks after. This will be purely descriptive, and again will be calculated from the continuous glucose monitors. 3. Change in frequency of hypoglycaemia and percentage of time spent in low and high blood glucose levels between week 1 and week 6 (effect of training). This will be calculated from the continuous glucose monitors. These will be compared using a paired T test or a non-parametric Wilcoxon test if the change scores are not normally distributed. In a previous study that we have done, the mean and SD of frequency of hypoglycaemia and percentage of time spent in low and high blood glucose levels were 18.2 + 2.8 hypoglycaemic episodes (hypos) per week, 6.8 + 1.9% of time in low blood glucose levels and 33.7 + 5.4% in high blood glucose levels. This means with a 100 and 50 people respectively we would have the power to detect a 0.78 or 1.2 difference in hypos per week, a 0.5% or 0.8% difference in time spent in low blood glucose level and 1.5% and 2.2% difference in time in high blood glucose levels. 4. Collation of different strategies used by the different participants to manage their T1D during training for and whilst completing a half marathon. This will be purely descriptive and we be grouped into changes in carbohydrate and protein intake, changes in insulin dosages and the combination of both. This will be collected from the questionnaires and patient diary.

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Secondary

Measure	Time frame
1. Change in average glucose control and lipids between week 1 (first test) and week 6 (second test). Glucose will be measured by HbA1c and lipids by total cholesterol, HDL, LDL and triglycerides. These will be compared using a paired T test or a non-parametric Wilcoxon test if the change scores are not normally distributed. In a previous study that we have done the mean and SD of HbA1c, HDL, LDL and triglycerides was 75 + 25 mmol/mol, 1.38 + 0.46 mmol/l, 3.05 + 0.78 mmol/l and 1.37 + 1.87 mmol/l respectively. This means with 100 and 50 people respectively we would have the power to detect a 7 or 10 mmol/mol difference in HbA1c, a 0.13 or 0.18 mmol/l in HDL, 0.22 or 0.3 mmol/L in LDL and 0.5 or 0.75 mmol/L in triglycerides. 2. Change in urinary C-peptides between week 1 (first test) and week 6 (second test). These will be compared using a paired T test or a non parametric Wilcoxon test if the change scores are not normally distributed. In a previous study that we have done the mean and SD of urinary C-peptide is 2.11 + 0.76 nmol/mmol. This means with 100 and 50 people respectively we would have the power to detect a 0.21 or 0.30 nmol/mmol difference in urinary C-peptide. 3. Change in T cell types, number and function between week 1 (first test) and week 6 (second test). This will be measured by standard immunology techniques - flow cytometry and cell culture. These will be compared using a paired T test or a non-parametric Wilcoxon test if the change scores are not normally distributed. This has not been looked at before in people with Type 1 diabetes but we have seen changes with an acute bout of exercise in 20 people with Type 1 diabetes so are confident if 20 or more people provide us with blood that we will see a difference. 4. Association of C-peptide with hypoglycaamic rates and time spent in normal glucose range. C-peptide will be measured in blood and hypoglycaemic rates and time spent in normal range will co	—

Measure

Time frame

1. Change in average glucose control and lipids between week 1 (first test) and week 6 (second test). Glucose will be measured by HbA1c and lipids by total cholesterol, HDL, LDL and triglycerides. These will be compared using a paired T test or a non-parametric Wilcoxon test if the change scores are not normally distributed. In a previous study that we have done the mean and SD of HbA1c, HDL, LDL and triglycerides was 75 + 25 mmol/mol, 1.38 + 0.46 mmol/l, 3.05 + 0.78 mmol/l and 1.37 + 1.87 mmol/l respectively. This means with 100 and 50 people respectively we would have the power to detect a 7 or 10 mmol/mol difference in HbA1c, a 0.13 or 0.18 mmol/l in HDL, 0.22 or 0.3 mmol/L in LDL and 0.5 or 0.75 mmol/L in triglycerides. 2. Change in urinary C-peptides between week 1 (first test) and week 6 (second test). These will be compared using a paired T test or a non parametric Wilcoxon test if the change scores are not normally distributed. In a previous study that we have done the mean and SD of urinary C-peptide is 2.11 + 0.76 nmol/mmol. This means with 100 and 50 people respectively we would have the power to detect a 0.21 or 0.30 nmol/mmol difference in urinary C-peptide. 3. Change in T cell types, number and function between week 1 (first test) and week 6 (second test). This will be measured by standard immunology techniques - flow cytometry and cell culture. These will be compared using a paired T test or a non-parametric Wilcoxon test if the change scores are not normally distributed. This has not been looked at before in people with Type 1 diabetes but we have seen changes with an acute bout of exercise in 20 people with Type 1 diabetes so are confident if 20 or more people provide us with blood that we will see a difference. 4. Association of C-peptide with hypoglycaamic rates and time spent in normal glucose range. C-peptide will be measured in blood and hypoglycaemic rates and time spent in normal range will co

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Countries

United Kingdom

Contacts

Public ContactRob Andrews

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026