Post-exercise Insulin Reductions in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01531855

Recruitment Status : Completed

First Posted : February 13, 2012

Last Update Posted : August 4, 2014

Sponsor:

Collaborator:

Diabetes UK

Information provided by (Responsible Party):

Northumbria University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes	Other: Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	13 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
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 Start Date :	February 2012
Actual Primary Completion Date :	August 2012
Actual Study Completion Date :	August 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 1 diabetes

MedlinePlus related topics: Diabetes Type 1 Exercise and Physical Fitness

Drug Information available for: Insulin Insulin human Insulin lispro

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Insulin dose Reducing rapid-acting insulin dose (insulin aspart or lispro) after exercise.	Other: Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose Dosage after exercise

Outcome Measures

Primary Outcome Measures :

24 hour blood glucose area under the curve [ Time Frame: 24 hours ]
24 hour, post-exercise, glucose area under the curve.

Secondary Outcome Measures :

Ketogenesis [ Time Frame: 60 minutes before and 24 hours post-exercise ]
Blood beta-hydroxybutyrate concentrations

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531855

Locations

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United Kingdom
Clinical Research Facility
Newcaslte upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP

Sponsors and Collaborators

Northumbria University

Diabetes UK

Investigators

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Principal Investigator:	Daniel J West	Northumbria University

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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Responsible Party:	Northumbria University
ClinicalTrials.gov Identifier:	NCT01531855
Other Study ID Numbers:	west-walker1
First Posted:	February 13, 2012 Key Record Dates
Last Update Posted:	August 4, 2014
Last Verified:	August 2014

Keywords provided by Northumbria University:


T1DM, Exercise

Additional relevant MeSH terms:

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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases	Immune System Diseases Insulin Insulin Lispro Insulin, Short-Acting Hypoglycemic Agents Physiological Effects of Drugs

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