Guidelines for Post-exercise Dietary Intake in T1DM

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Dietary Supplement: Meal composition

• Registration Number: NCT01794650
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-15
• Study First Posted: 2013-02-20
• Study Start: 2013-03
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meal composition	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).

Primary Outcome Measures

Name	Time	Method
24 hour blood glucose area under the curve	24 hours	24 hour, post-exercise, glucose area under the curve.

Secondary Outcome Measures

Name	Time	Method
Ketogenesis	60 minutes before and 24 hours post-exercise	Blood beta-hydroxybutyrate concentrations

Trial Locations

Locations (1)

Clinical Research Facility, Royal Victoria Infirmary; 🇬🇧 Newcastle upon Tyne, Tyne and Wear, United Kingdom