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

NCT04671043 | Completed DMC

• 1 other identifier: DE-CAF
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caffeine and Carbohydrate; Carbohydrate Only; Placebo

Keywords

caffeine; type 1 diabetes; exercise; hypoglycemia; glucose

Outcome Measures

Primary Outcomes (1)

• Hypoglycaemia

  Time to hypoglycaemia (plasma glucose \<3.9mmol/l) during the 60 min of exercise

  60 minutes from start of exercise

Secondary Outcomes (11)

• Change in blood glucose concentration

  60 minutes from start of exercise

• Mean glucose concentration

  60 minutes from start of exercise

• Area under the glucose curve

  60 minutes from start of exercise

• %-Time in target glycaemic range during recovery

  24 hours

• %-Time in target glycaemic range during exercise

  60 minutes

Study Arms (3)

CAF+lowCHO

EXPERIMENTAL

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

Dietary Supplement: Caffeine and glucose

10g CHO

ACTIVE COMPARATOR

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

Dietary Supplement: Glucose alone

placebo

PLACEBO COMPARATOR

A drink containing an artificial sweetener (aspartame) dissolved in 200 mL of tap water

Dietary Supplement: Placebo

Interventions

Caffeine and glucose DIETARY_SUPPLEMENT

Caffeine and glucose powder dissolved in water

CAF+lowCHO

Glucose alone DIETARY_SUPPLEMENT

Glucose powder dissolved in water

10g CHO

Placebo DIETARY_SUPPLEMENT

Artificial sweetener dissolved in water

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 diabetes for ≥1 year and negative C-peptide (\<100pmol/l)
• Male and female aged 18-45 years old
• HbA1c \<8.5% (69 mmol/mol) based on analysis from the central laboratory unit of Bern University Hospital
• Using multiple daily injections
• Using insulin degludec (Tresiba; Novo Nordisk A/S, Bagsværd, Denmark) as basal insulin for a minimum of 3 months
• Written informed consent
• Able and willing to adhere to safe contraception during the study and for 2 weeks after completion of the study. Safe contraception comprises double barrier methods (hormonal contraception \[like: oral contraceptive pills or intrauterine contraceptive devices\] together with a mechanical barrier \[like: condom, diaphragm\]).

You may not qualify if:

• Physical or psychological disease likely to interfere with the normal conduct of the study as judged by the investigator
• Continuous subcutaneous insulin infusion (using an insulin pump)
• Hypoglycaemic unawareness (Gold likert score ≥4) or having experienced any episode of a severe hypoglycaemic event within the last 6 months (i.e. need of third-party assistance).
• Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, SGLT2 inhibitors, Glucagon like 1 peptide- receptor agonists, or metformin.
• Relevant diabetic complications as judged by the investigator and based on medical record check (no cardiovascular disease and no significant microvascular disease)
• Microalbuminuria (as defined by area under the curve \>30 mg/g)
• Body mass index more than or equal to 30 kg/m2
• Uncontrolled hypertension (\>180/100 mmHg)
• Pregnant or planning to become pregnant during the study period (females only)
• Breastfeeding

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland

Bern, 3010, Switzerland

Location

Related Publications (25)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Interventions

Caffeine; Glucose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Christoph Stettler, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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)
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre, randomised, double-blind crossover design

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: February 4, 2022
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)