Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135915
Status:
COMPLETED
Last Update Posted:
2009-11-01
First Post:
2005-08-24
Brief Title:
Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study
Sponsor:
The Royal Bournemouth Hospital
Organization:
The Royal Bournemouth Hospital
Study Overview
Official Title:
Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 componentApart 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 wineOutcome measures are the results of the effect of acute ingestion of alcohol on glucose levels and intermediate metabolites in subjects with Type I diabetes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None