Diabetes Mellitus, Type 1NCT00135915
Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study
An observational study of Diabetes Mellitus, Type 1, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2005to Feb 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males or females of at least 18 years of age who were diagnosed with Type 1 diabetes more than 5 years ago.
Who may be able to join
- 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
Who cannot join
- Type 2 diabetes
- Type I diabetes < 5 years
- Excessive alcohol consumption
- Unstable diabetes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startAug 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Investigators
- David Kerr, Doctor, Principal investigator, The Royal Bournemouth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135915
- Sponsor's protocol ID
- BDEC ALC 1
- Status last verified
- Oct 2009
- First submitted
- 24 Aug 2005
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study
- ClinicalTrials.gov ID
- NCT00135915
- Acronym / sponsor ID
- BDEC ALC 1
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 26 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males or females of at least 18 years of age who were diagnosed with Type 1 diabetes more than 5 years ago.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Type 2 diabetes
- Type I diabetes < 5 years
- Excessive alcohol consumption
- Unstable diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kerr, Doctor principal investigator
The Royal Bournemouth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2009.