Post-exercise Insulin Reductions in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

The Metabolic and Glycaemic Responses to Reductions in Rapid-acting Insulin Dose After Running Exercise in People With Type 1 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531855
• Other study ID #: west-walker1
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: August 1, 2014
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: August 2014
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesise that reducing rapid-acting insulin dose after exercise will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• T1DM,

• Male,

• basal-bolus regimen (insulin glargine / detemir with insulin lispro / aspart),

• HbA1c < 9.9%,

• aged 18-50.

Exclusion Criteria:

• HbA1c > 10%,

• not treated with basal-bolus (insulin glargine / detemir with insulin lispro / aspart),

• aged <18 > 50.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose
Dosage after exercise

Locations

Country	Name	City	State
United Kingdom	Clinical Research Facility	Newcaslte upon Tyne	Tyne and Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Diabetes UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

West DJ, Morton RD, Bain SC, Stephens JW, Bracken RM. Blood glucose responses to reductions in pre-exercise rapid-acting insulin for 24 h after running in individuals with type 1 diabetes. J Sports Sci. 2010 May;28(7):781-8. doi: 10.1080/02640411003734093. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour blood glucose area under the curve	24 hour, post-exercise, glucose area under the curve.	24 hours	No
Secondary	Ketogenesis	Blood beta-hydroxybutyrate concentrations	60 minutes before and 24 hours post-exercise	No