Clinical trial NCT01805700: Effects of Acute Intake of Caffeinated Beverages in Type 1 Diabetes
Official title: Effects of Acute Intake of Caffeine Enhanced Energy Drinks on Blood Glucose, Some Physiological Parameters and Cognitive Performance in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1
diabetes
caffeine-enhanced energy drink
cardiac output
glucose
cognitive performance
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this pilot study is to determine the impact of caffeine-enhanced energy drinks on blood glucose excursion on heart rate, blood pressure, cardiac output and cognitive performance in patients with type 1 diabetes.

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.


Eligibility criteria: Inclusion Criteria:

* Male and female adults aged ≥18 years
* 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:

* Hypoglycaemia unawareness
* Coronary heart disease
* Cardiac arrhythmia
* Structural heart lesions,
* Autonomic neuropathy
* Psychiatry illness,
* Epilepsy
* Migraine
* Caffeine intolerance
* Unable to provide informed consent

Primary outcomes:
measure: Changes in blood glucose level in all patients as a measure of tolerability
timeFrame: Day 1, Day 2 and Day 3
Secondary outcomes:
measure: The effects on certain mood states, e.g. energetic arousal, tense arousal and hedonic tone following the consumption of caffeinated energy drinks in comparison with caffeine free glucose in patients with type 1 diabetes
timeFrame: Day 1, day 2 and day 3
measure: Changes in reaction time and digit symbol substitution test score
timeFrame: Day 1, day 2 and day 3
measure: Changes in heart rate, systolic and diastolic blood pressure in all patients.
timeFrame: Day 1, day 2 and day 3
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
state: Dorset
Study officials:
affiliation: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
name: Tolulope Olateju, MRCP
role: PRINCIPAL_INVESTIGATOR
References: