Completed
The Metabolic and Glycaemic Responses to Changes in the Glycaemic Index of the Meal Consumed After Performing Evening Exercise in Type 1 Diabetes Mellitus
What is being tested
Meal composition
Dietary Supplement
Who is being recruted
Autoimmune Diseases+8
+ Behavior
+ Diabetes Mellitus
From 18 to 50 Years
+10 Eligibility Criteria
How is the trial designed
Basic Science Study
Interventional
Study Start: March 2013
Summary
Principal SponsorNorthumbria University
Last updated: November 15, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorNorthumbria University
Last updated: November 15, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Autoimmune DiseasesBehaviorDiabetes MellitusEndocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 1HypoglycemiaMotor Activity
Criteria
5 inclusion criteria required to participate
Aged between 18-50 years old (male or female)
Demonstrate normal cardiac function in response to exercise
Free from any diabetes related complications (apart from mild background diabetic retinopathy)
HbA1c < 8.5%
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5 exclusion criteria prevent from participating
Aged younger than 18, or older than 50 years
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
HbA1c > 8.5%
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
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).
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Clinical Research Facility, Royal Victoria Infirmary
Newcastle upon Tyne, United KingdomOpen Clinical Research Facility, Royal Victoria Infirmary in Google MapsCompletedOne Study Center