Home
Clinical Trials
Caffeine Ingestion to Counter...

Caffeine Ingestion to Counter the Exercise-mediated Fall in Glycaemia in Type 1 Diabetes

Last Updated: 2023-03-14

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-04

Study Completion Date

2023-02-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This project will aim to investigate the clinical efficacy and metabolic effects of a pre-exercise dose of caffeine with a low (10g) dose of carbohydrate (CAF+lowCHO) without modification of insulin degludec on exercise metabolism in people with T1D.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Insulin-based Strategies to Prevent Hypoglycemia During Exercise

NCT03349489

Type 1 Diabetes Mellitus

UNKNOWN NA

Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin

NCT03400501

Type 1 Diabetes Mellitus

COMPLETED EARLY_PHASE1

Impact of Physical Activity on Blood Glucose Stability and Energy Stores in Individuals With Type 1 Diabetes

NCT02068638

Type 1 Diabetes Mellitus Exercise Hypoglycemia +1 more

COMPLETED NA

Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses

NCT03490942

Hypoglycemia Unawareness Diabetes Mellitus, Type 1

TERMINATED PHASE2

Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose

NCT04623086

Type 1 Diabetes

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Treatment of type 1 diabetes (T1D) involves lifelong use of exogenous insulin to manage blood glucose concentration. As with the rest of the population, people living with T1D are recommended to engage in regular exercise for a variety of health and fitness reasons . However, glycaemic control during exercise remains a particular challenge for this population due to rapid changes in insulin sensitivity and the impact of additional hormones which increase the risk of exercise-related hypoglycaemia. Current guidelines to prevent exercise-induced hypoglycaemia suggest insulin dose reduction and/or ingestion of carbohydrates in the context of the exercise bout. However, these adaptations are often difficult to apply, as insulin dose adjustments require knowledge of insulin pharmacokinetics and advanced planning which is not always possible. None of these strategies provide complete assurance that hypoglycaemia will not occur and high carbohydrate intake can be counterproductive if weight management is the target. Furthermore, modern very long-acting insulin analogues, which are favoured by many people with T1D, do not offer the option to rapidly or transiently reduce insulin before exercise. When using such insulins, dose reductions may take two to three days to achieve an adapted steady state, increasing the risk of inadequate insulin following exercise. Collectively, these factors increase the risk of further deterring patients from exercise. Simple, alternative strategies to reduce the risk of hypoglycaemia, both during and after exercise are needed.

Caffeine (1,3,7-trimethylxanthine) is the most commonly consumed chemical stimulant in the world that is naturally found in many foods and is frequently added to sports supplements due to its ergogenic effects in a range of sporting events. Caffeine has numerous physiological effects throughout the body including increased lipolysis in adipose tissues and hepatic glucose production in the liver alongside a decrease in glucose uptake in skeletal muscle. These responses have led to the suggestion that acute caffeine intake may attenuate exercise-associated hypoglycaemia in people with T1D. Ingestion of modest amounts of caffeine (200-250 mg, equivalent to 3-4 cups of coffee each day) has been shown to augment the symptomatic and hormonal responses to hypoglycaemia in participants with and without T1D. Caffeine has also been shown to reduce the frequency of moderate episodes of hypoglycaemia occurring overnight. The paucity of data on caffeine and exercise in individuals with T1D, in conjunction with caffeine's popularity both socially and as a sports supplement, suggests this deserves further attention.

A clear example whereby caffeine supplementation may be of use is in patients using an ultra-long acting basal insulin analogue such as insulin degludec. The administration is via subcutaneous injection once daily, and it has a duration of action that lasts up to 42 hours (compared to 18 to 26 hours provided by other marketed long-acting insulins such as insulin glargine and insulin detemir). On average, the half-life at steady state is approximately 25 hours independent of dose. Compared to the other basal insulin analogues, the risk of hypoglycaemia appears to be lower with insulin degludec, however, hypoglycaemia still occurs. In the case of physical exercise, the inability of the patient using such long-acting insulins to make rapid adjustments can translate to the occurrence of exercise-related hypoglycaemia due to an inability to reduce insulin already onboard, hence the need for new strategies to prevent this undesired phenomenon. When using such insulins, dose reductions may take two to three days to achieve an adapted steady state, increasing the risk of inadequate insulin following exercise. Applying a novel in-house developed lipid chromatography-mass spectrometry (LC-MS) assay, members of our research group observed that a single bout of aerobic exercise increases systemic insulin degludec concentrations in adults on stable basal insulin degludec regimens. Therefore, if these individuals wish to engage in regular exercise, as recommended in international guidelines, current treatment strategies may not be sufficient. For patients treated with modern basal insulin analogues, it seems more adequate not to modify the ultra-long acting insulin doses, as this can often result in more confusion than improvement, but to apply alternative strategies for recreational exercise. Caffeine ingestion pre or post exercise may offer a simple means to better manage glycaemia in the context of exercise in patients using these insulins and have the added benefit of reducing carbohydrate requirements in the context of exercise.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caffeine and Carbohydrate Carbohydrate Only Placebo

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single-centre, randomised, double-blind crossover design

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

In each of the conditions, participants will receive a taste-matched drink containing either • caffeine and 10 g rapid-acting carbohydrate (CAF+lowCHO); 20 g rapid acting carbohydrate (20g CHO); or placebo. The drink will be made by an independent member of the research team to ensure that neither the investigators or participants know the order of the drinks (double-blind)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CAF+lowCHO

A drink containing caffeine and 10 g rapid-acting carbohydrate (glucose) dissolved in 200 mL of tap water

Group Type EXPERIMENTAL