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Trial record 11 of 1046 for:    Area Under Curve AND insulin

Post-exercise Insulin Reductions in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 7, 2012
First Posted Date  ICMJE February 13, 2012
Last Update Posted Date August 4, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
24 hour blood glucose area under the curve [ Time Frame: 24 hours ]
24 hour, post-exercise, glucose area under the curve.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01531855 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
Ketogenesis [ Time Frame: 60 minutes before and 24 hours post-exercise ]
Blood beta-hydroxybutyrate concentrations
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-exercise Insulin Reductions in Type 1 Diabetes
Official Title  ICMJE The Metabolic and Glycaemic Responses to Reductions in Rapid-acting Insulin Dose After Running Exercise in People With Type 1 Diabetes Mellitus.
Brief Summary The investigators hypothesise that reducing rapid-acting insulin dose after exercise will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Other: Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose
Dosage after exercise
Study Arms  ICMJE Insulin dose
Reducing rapid-acting insulin dose (insulin aspart or lispro) after exercise.
Intervention: Other: Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2014)
13
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2012)
16
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531855
Other Study ID Numbers  ICMJE west-walker1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northumbria University
Study Sponsor  ICMJE Northumbria University
Collaborators  ICMJE Diabetes UK
Investigators  ICMJE
Principal Investigator: Daniel J West Northumbria University
PRS Account Northumbria University
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP