- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01794650
Guidelines for Post-exercise Dietary Intake in T1DM
November 14, 2013 updated by: Northumbria University
The Metabolic and Glycaemic Responses to Changes in the Glycaemic Index of the Meal Consumed After Performing Evening Exercise in Type 1 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE10 9PY
- Clinical Research Facility, Royal Victoria Infirmary
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-
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
All
Description
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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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).
|
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
Investigators
- Principal Investigator: Daniel J West, PhD, BSc, Northumbria University
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
March 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
February 15, 2013
First Submitted That Met QC Criteria
February 15, 2013
First Posted (Estimate)
February 20, 2013
Study Record Updates
Last Update Posted (Estimate)
November 15, 2013
Last Update Submitted That Met QC Criteria
November 14, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- West-Walker2
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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