Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study

NCT ID: NCT00135915

Last Updated: 2009-11-02

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

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-02-28

Brief Summary

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Although there is no evidence that individuals with type 1 diabetes have a different approach to alcohol compared to the background population, nevertheless, its use does have implications for patients mainly because of the risk of hypoglycaemia unawareness. However, binge drinking has been implicated as a factor in the development of ketoacidosis and is probably under-recognised. The aim of this study is to examine the effect of binge drinking on glucose, insulin, counter-regulatory hormones and other metabolites in patients with type 1 diabetes. It is hoped that data from this project will be used to develop a larger study comparing different treatment regimens for patients using alcohol to reduce the risks of hyperglycaemia as well as hypoglycaemia.

Detailed Description

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This is a randomised trial involving Type I diabetics who have had Type I diabetes \>5 years. They will be using multiple daily injections of a basal insulin and a rapid acting component.Apart from insulin and oral contraceptive, none will be on regular medication. All will be regular consumers of modest amount of alcohol (Female - less than or equal to 14 units, males - less than or equal to 21 units). Each will participate in 2 studies. Subjects will be randomised either to white wine or an equivalent volume of alcohol-free wine.Outcome measures are the results of the effect of acute ingestion of alcohol on glucose levels and intermediate metabolites in subjects with Type I diabetes.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes for \> 5 years
* Use of multiple daily injections of a basal insulin and a rapid acting component
* Regular consumption of modest amounts of alcohol

Exclusion Criteria

* Type 2 diabetes
* Type I diabetes \< 5 years
* Excessive alcohol consumption
* Unstable diabetes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Royal Bournemouth Hospital

OTHER

Sponsor Role lead

Principal Investigators

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David Kerr, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Royal Bournemouth Hospital

Locations

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Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BDEC ALC 1

Identifier Type: -

Identifier Source: org_study_id

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