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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 1, 2014
Last verified: August 2014
  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:


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


Enrollment: 13
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 1, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Northumbria University:
T1DM, Exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin Lispro
Insulin, Globin Zinc
Insulin, Short-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014