Guidelines for Post-exercise Dietary Intake in T1DM
The Metabolic and Glycaemic Responses to Changes in the Glycaemic Index of the Meal Consumed After Performing Evening Exercise in Type 1 Diabetes Mellitus
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 15, 2013
November 1, 2013
8 months
February 15, 2013
November 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24 hour blood glucose area under the curve
24 hour, post-exercise, glucose area under the curve.
24 hours
Secondary Outcomes (1)
Ketogenesis
60 minutes before and 24 hours post-exercise
Study Arms (1)
Meal composition
OTHERChanging 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Facility, Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, NE10 9PY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel J West, PhD, BSc
Northumbria University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2013
First Posted
February 20, 2013
Study Start
March 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 15, 2013
Record last verified: 2013-11