Back to resultsGuidelines for Post-exercise Dietary Intake in T1DM
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Meal composition
Sponsored by
About this trial
This is an interventional basic science trial for Type 1 Diabetes Mellitus focused on measuring T1DM, Exercise, Hypoglycaemia
Eligibility 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.
Sites / Locations
- Clinical Research Facility, Royal Victoria Infirmary
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Meal composition
Arm Description
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).
Outcomes
Primary Outcome Measures
24 hour blood glucose area under the curve
24 hour, post-exercise, glucose area under the curve.
Secondary Outcome Measures
Ketogenesis
Blood beta-hydroxybutyrate concentrations
Full Information
NCT ID
NCT01794650
First Posted
February 15, 2013
Last Updated
November 14, 2013
Sponsor
Northumbria University
1. Study Identification
Unique Protocol Identification Number
NCT01794650
Brief Title
Guidelines for Post-exercise Dietary Intake in T1DM
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 Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northumbria University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
T1DM, Exercise, Hypoglycaemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meal composition
Arm Type
Other
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Meal composition
Primary Outcome Measure Information:
Title
24 hour blood glucose area under the curve
Description
24 hour, post-exercise, glucose area under the curve.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Ketogenesis
Description
Blood beta-hydroxybutyrate concentrations
Time Frame
60 minutes before and 24 hours post-exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J West, PhD, BSc
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Facility, Royal Victoria Infirmary
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE10 9PY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Guidelines for Post-exercise Dietary Intake in T1DM
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