Guidelines for Post-exercise Dietary Intake in T1DM

NCT ID: NCT01794650

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Type 1 Diabetes Mellitus

Keywords

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T1DM, Exercise, Hypoglycaemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Meal composition

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Meal composition

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel J West, PhD, BSc

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

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Clinical Research Facility, Royal Victoria Infirmary

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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West-Walker2

Identifier Type: -

Identifier Source: org_study_id