Effects of Acute Intake of Caffeinated Beverages in Type 1 Diabetes
NCT ID: NCT01805700
Last Updated: 2013-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2010-01-31
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Knowledge acquired may inform a wider study of the impact of these drinks.
This is a randomised, cross over blinded study in which all participants will participate in the 3 arms of the study.
The study will consist of 3 phases, each lasting 3 days. A different study drink will be administered during each phase. There will be an initial screening visit and a pre- study visit before each study phase. Each participant will make 10 visits to the research centre.
There will be a week wash out period between each study phase. Prior to each study phase, there will be a 3 day caffeine and alcohol abstinence run-in period.
Study drinks will be matched for taste and volume (as far as possible) and will be administered by the use of opaque cups, lids and straws to enable double-blind randomisation for both researcher and participants. Administration of the study drink to participants will be based on Latin squares to provide a balanced treatment order.
During the 3 days study period; participants will be required to abstain from all other caffeine containing beverages or confectioneries.
The secondary aim is to determine if tolerance to cardiovascular effects of caffeine-enhanced energy drinks is developed following acute short term ingestion.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Experimental Studies of the Effects of Caffeine on Glucose Regulation
NCT00432887
The Acute Effects of Coffee on Glucose Metabolism
NCT00950898
The Effects of Specialty Coffee on Cognitive Function in People With Type 2 Diabetes
NCT05709847
Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus
NCT01908348
Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
NCT00592072
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Regular caffeine enhanced energy drink
Regular caffeine enhanced energy drink (containing 240mg caffeine \& 84g glucose) e.g. regular red bull cans (x3)
Caffeine enhanced energy drink
Comparison of different energy drinks
Diet Caffeine enhanced energy drink
Diet Caffeine enhanced energy drink ( containing 240mg of caffeine alone) e.g. Red Bull light)
Caffeine enhanced energy drink
Comparison of different energy drinks
Glucose drink
Glucose drink (containing 84g glucose alone)
Glucose drink
Glucose drink (containing 84mg glucose alone)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Caffeine enhanced energy drink
Comparison of different energy drinks
Glucose drink
Glucose drink (containing 84mg glucose alone)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Confirmed diagnosis of Type 1 diabetes of more than one year duration
* Participants who use multiple daily injections of basal and meal-time analogue insulin.
* Ability to perform daily finger stick measurements of blood glucose levels
* Adequate contraceptive control
* Provision of informed consent
Exclusion Criteria
* Coronary heart disease
* Cardiac arrhythmia
* Structural heart lesions,
* Autonomic neuropathy
* Psychiatry illness,
* Epilepsy
* Migraine
* Caffeine intolerance
* Unable to provide informed consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Royal Bournemouth Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tolulope Olateju, MRCP
Role: PRINCIPAL_INVESTIGATOR
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, Dorset, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B091217
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.