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Trial record 15 of 750 for:    Area Under Curve AND meal

Guidelines for Post-exercise Dietary Intake in T1DM

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. Identifier: NCT01794650
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : November 15, 2013
Information provided by (Responsible Party):
Northumbria University

Brief Summary:
The investigators hypothesise that manipulating the glycaemic index of the meal after exercise and before sleep will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Dietary Supplement: Meal composition 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 Responses to Changes in the Glycaemic Index of the Meal Consumed After Performing Evening Exercise in Type 1 Diabetes Mellitus
Study Start Date : March 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Meal composition
Changing the glycaemic index of the meals consumed after exercise and before sleep. (High GI - High GI, Low GI - Low GI, High GI - Low GI, Low GI - High GI).
Dietary Supplement: Meal composition

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

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:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01794650

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United Kingdom
Clinical Research Facility, Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE10 9PY
Sponsors and Collaborators
Northumbria University
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Principal Investigator: Daniel J West, PhD, BSc Northumbria University

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Responsible Party: Northumbria University Identifier: NCT01794650     History of Changes
Other Study ID Numbers: West-Walker2
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013
Keywords provided by Northumbria University:
T1DM, Exercise, Hypoglycaemia
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