Post-exercise Insulin Reductions in Type 1 Diabetes

August 1, 2014 updated by: Northumbria University

The Metabolic and Glycaemic Responses to Reductions in Rapid-acting Insulin Dose After Running Exercise in People With Type 1 Diabetes Mellitus.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour blood glucose area under the curve
Time Frame: 24 hours
24 hour, post-exercise, glucose area under the curve.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ketogenesis
Time Frame: 60 minutes before and 24 hours post-exercise
Blood beta-hydroxybutyrate concentrations
60 minutes before and 24 hours post-exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Collaborators

Diabetes UK

Investigators

  • Principal Investigator: Daniel J West, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (ESTIMATE)

February 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2014

Last Update Submitted That Met QC Criteria

August 1, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • west-walker1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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