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NCT00135915 Clinical Trial

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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00135915
Other study ID # BDEC ALC 1
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 24, 2005
Last updated October 30, 2009
Start date August 2005
Est. completion date February 2007

Study information
Verified date October 2009
Source The Royal Bournemouth Hospital
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal Bournemouth Hospital Bournemouth Dorset

Sponsors (1)
Lead Sponsor Collaborator
The Royal Bournemouth Hospital

Country where clinical trial is conducted

United Kingdom, 

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