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Post-exercise Insulin Reductions in Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes focused on measuring T1DM, Exercise

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research Facility

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Insulin dose

Arm Description

Reducing rapid-acting insulin dose (insulin aspart or lispro) after exercise.

Outcomes

Primary Outcome Measures

24 hour blood glucose area under the curve
24 hour, post-exercise, glucose area under the curve.

Secondary Outcome Measures

Ketogenesis
Blood beta-hydroxybutyrate concentrations

Full Information

First Posted
February 7, 2012
Last Updated
August 1, 2014
Sponsor
Northumbria University
Collaborators
Diabetes UK
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1. Study Identification

Unique Protocol Identification Number
NCT01531855
Brief Title
Post-exercise Insulin Reductions in Type 1 Diabetes
Official Title
The Metabolic and Glycaemic Responses to Reductions in Rapid-acting Insulin Dose After Running Exercise in People With Type 1 Diabetes Mellitus.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northumbria University
Collaborators
Diabetes UK

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
T1DM, Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin dose
Arm Type
Other
Arm Description
Reducing rapid-acting insulin dose (insulin aspart or lispro) after exercise.
Intervention Type
Other
Intervention Name(s)
Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose
Intervention Description
Dosage after exercise
Primary Outcome Measure Information:
Title
24 hour blood glucose area under the curve
Description
24 hour, post-exercise, glucose area under the curve.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Ketogenesis
Description
Blood beta-hydroxybutyrate concentrations
Time Frame
60 minutes before and 24 hours post-exercise

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J West
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Facility
City
Newcaslte upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20496226
Citation
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.
Results Reference
background
PubMed Identifier
24858952
Citation
Campbell MD, Walker M, Trenell MI, Luzio S, Dunseath G, Tuner D, Bracken RM, Bain SC, Russell M, Stevenson EJ, West DJ. Metabolic implications when employing heavy pre- and post-exercise rapid-acting insulin reductions to prevent hypoglycaemia in type 1 diabetes patients: a randomised clinical trial. PLoS One. 2014 May 23;9(5):e97143. doi: 10.1371/journal.pone.0097143. eCollection 2014.
Results Reference
derived
PubMed Identifier
23514728
Citation
Campbell MD, Walker M, Trenell MI, Jakovljevic DG, Stevenson EJ, Bracken RM, Bain SC, West DJ. Large pre- and postexercise rapid-acting insulin reductions preserve glycemia and prevent early- but not late-onset hypoglycemia in patients with type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2217-24. doi: 10.2337/dc12-2467. Epub 2013 Mar 20.
Results Reference
derived

Learn more about this trial

Post-exercise Insulin Reductions in Type 1 Diabetes

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