NCT00135915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

First QC Date

August 24, 2005

Last Update Submit

October 30, 2009

Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males or females of at least 18 years of age who were diagnosed with Type 1 diabetes more than 5 years ago.

You may qualify if:

  • 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

You may not qualify if:

  • Type 2 diabetes
  • Type I diabetes \< 5 years
  • Excessive alcohol consumption
  • Unstable diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • David Kerr, Doctor

    The Royal Bournemouth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

August 1, 2005

Study Completion

February 1, 2007

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations