Post-exercise Insulin Reductions in Type 1 Diabetes

This study has been completed.

Sponsor:

Collaborator:

Diabetes UK

Information provided by (Responsible Party):

Northumbria University

ClinicalTrials.gov Identifier:

NCT01531855

First received: February 7, 2012

Last updated: August 17, 2012

Last verified: August 2012

History of Changes

Purpose

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

Condition	Intervention
Type 1 Diabetes	Other: Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1 Exercise and Physical Fitness

Drug Information available for: Insulin human Insulin lispro

U.S. FDA Resources

Further study details as provided by Northumbria University:

Primary Outcome Measures:

24 hour blood glucose area under the curve [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
24 hour, post-exercise, glucose area under the curve.

Secondary Outcome Measures:

Ketogenesis [ Time Frame: 60 minutes before and 24 hours post-exercise ] [ Designated as safety issue: No ]
Blood beta-hydroxybutyrate concentrations

Estimated Enrollment:	16
Study Start Date:	February 2012
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531855

Locations

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

Sponsors and Collaborators

Northumbria University

Diabetes UK

Investigators

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.

Responsible Party:	Northumbria University
ClinicalTrials.gov Identifier:	NCT01531855 History of Changes
Other Study ID Numbers:	west-walker1
Study First Received:	February 7, 2012
Last Updated:	August 17, 2012
Health Authority:	United Kingdom: National Health Service

Keywords provided by Northumbria University:

T1DM, Exercise

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases

Immune System Diseases
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

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