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Combined Basal-bolus Insulin and Post-exercise Carbohydrate Feeding Strategy in T1DM

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ClinicalTrials.gov Identifier: NCT02204839
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : January 15, 2015
Sponsor:
Collaborator:
Newcastle University
Information provided by (Responsible Party):
Northumbria University

Brief Summary:
The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate feeding and rapid-acting insulin dose recommendations will protect patients with type 1 diabetes from early- and late-onset hypoglycaemia following evening time exercise.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Basal insulin dose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Metabolic and Glycaemic Effects of a Combined Basal-Bolus Insulin Reduction And Carbohydrate Feeding Strategy For Evening Exercise in Type 1 Diabetes Mellitus
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Basal dose reduction
Total daily basal (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) reduction of 20% versus normal basal dose.
Drug: Basal insulin dose
Other Name: (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk)




Primary Outcome Measures :
  1. 24 hour blood glucose area under the curve [ Time Frame: 24 hours ]
    24 hour blood glucose area under the curve


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



Information from the National Library of Medicine

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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:

  • Aged between 18-50 years old (male or female).
  • Free from any diabetes related complications (apart from mild background diabetic retinopathy).
  • HbA1c <8.5%.
  • Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
  • Demonstrate normal cardiac function in response to exercise.

Exclusion Criteria:

  • Aged younger than 18, or older than 50 years.
  • Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
  • HbA1c >8.5%.
  • Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
  • Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.

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): NCT02204839


Locations
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United Kingdom
Clinical Research Facility, Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Sponsors and Collaborators
Northumbria University
Newcastle University
Investigators
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Principal Investigator: Daniel J West, PhD Northumbria University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT02204839     History of Changes
Other Study ID Numbers: West-Walker3
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015
Keywords provided by Northumbria University:
T1DM, Exercise, Hypoglycaemia
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Detemir
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs