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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
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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
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


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 24 hour blood glucose area under the curve [ Time Frame: 24 hours ]
    24 hour, post-exercise, glucose area under the curve.


Secondary Outcome Measures :
  1. Ketogenesis [ Time Frame: 60 minutes before and 24 hours post-exercise ]
    Blood beta-hydroxybutyrate concentrations


Eligibility Criteria
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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
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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
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Publications:

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

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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT01531855     History of Changes
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, Globin Zinc
Insulin Lispro
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs