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

This study has been completed.
Sponsor:
Information provided by:
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT00135915
First received: August 24, 2005
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

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.


Condition Phase
Diabetes Mellitus, Type 1
Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study

Resource links provided by NLM:


Further study details as provided by The Royal Bournemouth Hospital:

Enrollment: 10
Study Start Date: August 2005
Study Completion Date: February 2007
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135915

Locations
United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Sponsors and Collaborators
The Royal Bournemouth Hospital
Investigators
Principal Investigator: David Kerr, Doctor The Royal Bournemouth Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00135915     History of Changes
Other Study ID Numbers: BDEC ALC 1
Study First Received: August 24, 2005
Last Updated: October 30, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Binge Drinking
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol Drinking
Drinking Behavior
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014