Caffeine and CarbohydrateDE-CAFNCT04671043
Caffeine Ingestion to Counter the Exercise-mediated Fall in Glycaemia in Type 1 Diabetes
A study testing Caffeine and glucose and Glucose alone in people with Caffeine and Carbohydrate and Carbohydrate Only, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine and Carbohydrate, Carbohydrate Only, Placebo
- What is being tested?
- Caffeine and glucose and Glucose alone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Feb 2022to 2 Feb 2023
- Phase
- Interventional
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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]).
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
Bern, 3010
About this study
Official title: Does Combined Caffeine and Carbohydrate Ingestion Counter the Exercise-mediated Fall in Glycaemia in Individuals With Type 1 Diabetes on Insulin Degludec? The DE-CAF Study
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.
Read the detailed description
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
- Caffeine and Carbohydrate, Carbohydrate Only, Placebo
- Being tested
- Caffeine and glucose, Glucose alone, Placebo
- Keywords
- caffeine, type 1 diabetes, exercise, hypoglycemia, glucose
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine and glucoseDietary supplement
Caffeine and glucose powder dissolved in water
Glucose aloneDietary supplement
Glucose powder dissolved in water
PlaceboDietary supplement
Artificial sweetener dissolved in water
| Study group | Role | What they receive |
|---|---|---|
| CAF+lowCHO | Experimental | A drink containing caffeine and 10 g rapid-acting carbohydrate (glucose) dissolved in 200 mL of tap water Receives: 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 Receives: Dietary Supplement: Glucose alone |
| placebo | Placebo comparator | A drink containing an artificial sweetener (aspartame) dissolved in 200 mL of tap water Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycaemia
Time to hypoglycaemia (plasma glucose <3.9mmol/l) during the 60 min of exercise
Measured: 60 minutes from start of exercise
Secondary outcomes (11)
Change in blood glucose concentration
Change in blood glucose concentration, calculated based on the participants' glucose at the start of exercise and the last value measured at the end of exercise. If the exercise is stopped early because of hypoglycaemia, the last exercise glucose value will be used for analysis.
Measured: 60 minutes from start of exercise
Mean glucose concentration
Mean glucose concentration during the exercise bout
Measured: 60 minutes from start of exercise
Area under the glucose curve
Area under the glucose curve during exercise
Measured: 60 minutes from start of exercise
%-Time in target glycaemic range during recovery
Time in target glycaemic range (4-10 mmol/l) in the recovery period and overnight
Measured: 24 hours
%-Time in target glycaemic range during exercise
Time in target glycaemic range (4-10 mmol/l) during exercise
Measured: 60 minutes
Incidence of hypoglycaemia during exercise
Incidence of hypoglycaemia (≤3.9 mmol/l) during exercise
Measured: 60 minutes
Incidence of hypoglycaemia during recovery
Incidence of hypoglycaemia (≤3.9 mmol/l for 15 min or more) during the 24 hour post exercise recovery period
Measured: 24 hours
% Time below target range (< 3.9 mmol/L) during nighttime after exercise
The % time of glucose sensor measurements < 3.9 mmol/L in the night following the exercise visits will be documented
Measured: 12:00 am until 06:00 am after each exercise visit
% Time below target range (> 10.0 mmol/L) during nighttime after exercise
The % time of glucose sensor measurements > 10.0 mmol/L in the night following the exercise visits will be documented
Measured: 12:00 am until 06:00 am after each exercise visit
Mean sensor glucose overnight
The mean sensor glucose in mmol/L in the nights following the exercise visits will be documented
Measured: 12:00 am until 06:00 am after each exercise visit
Area under the glucose curve post exercise
The sensor glucose in mmol/L within 30 minutes following the exercise visits will be documented and the area under the curve will be calculated
Measured: 30 minutes after stop of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start4 Feb 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Caffeine and CarbohydrateStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-centre, randomised, double-blind crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Stettler, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671043
- Sponsor's protocol ID
- DE-CAF
- Acronym
- DE-CAF
- Status last verified
- Mar 2023
- First submitted
- 10 Dec 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brazeau AS, Rabasa-Lhoret R, Strychar I, Mircescu H. Barriers to physical activity among patients with type 1 diabetes. Diabetes Care. 2008 Nov;31(11):2108-9. doi: 10.2337/dc08-0720. Epub 2008 Aug 8.
PubMed 18689694Buzzetti R, Zampetti S, Pozzilli P. Impact of obesity on the increasing incidence of type 1 diabetes. Diabetes Obes Metab. 2020 Jul;22(7):1009-1013. doi: 10.1111/dom.14022. Epub 2020 Mar 24.
PubMed 32157790Campbell MD, Walker M, Bracken RM, Turner D, Stevenson EJ, Gonzalez JT, Shaw JA, West DJ. Insulin therapy and dietary adjustments to normalize glycemia and prevent nocturnal hypoglycemia after evening exercise in type 1 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 May 12;3(1):e000085. doi: 10.1136/bmjdrc-2015-000085. eCollection 2015.
PubMed 26019878Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.
PubMed 27926890Costill DL, Dalsky GP, Fink WJ. Effects of caffeine ingestion on metabolism and exercise performance. Med Sci Sports. 1978 Fall;10(3):155-8.
PubMed 723503Debrah K, Sherwin RS, Murphy J, Kerr D. Effect of caffeine on recognition of and physiological responses to hypoglycaemia in insulin-dependent diabetes. Lancet. 1996 Jan 6;347(8993):19-24. doi: 10.1016/s0140-6736(96)91557-3.
PubMed 8531542Dedrick S, Sundaresh B, Huang Q, Brady C, Yoo T, Cronin C, Rudnicki C, Flood M, Momeni B, Ludvigsson J, Altindis E. The Role of Gut Microbiota and Environmental Factors in Type 1 Diabetes Pathogenesis. Front Endocrinol (Lausanne). 2020 Feb 26;11:78. doi: 10.3389/fendo.2020.00078. eCollection 2020.
PubMed 32174888Francescato MP, Geat M, Fusi S, Stupar G, Noacco C, Cattin L. Carbohydrate requirement and insulin concentration during moderate exercise in type 1 diabetic patients. Metabolism. 2004 Sep;53(9):1126-30. doi: 10.1016/j.metabol.2004.03.015.
PubMed 15334372Ganio MS, Klau JF, Casa DJ, Armstrong LE, Maresh CM. Effect of caffeine on sport-specific endurance performance: a systematic review. J Strength Cond Res. 2009 Jan;23(1):315-24. doi: 10.1519/JSC.0b013e31818b979a.
PubMed 19077738Graham TE, Sathasivam P, Rowland M, Marko N, Greer F, Battram D. Caffeine ingestion elevates plasma insulin response in humans during an oral glucose tolerance test. Can J Physiol Pharmacol. 2001 Jul;79(7):559-65.
PubMed 11478588Greer F, Hudson R, Ross R, Graham T. Caffeine ingestion decreases glucose disposal during a hyperinsulinemic-euglycemic clamp in sedentary humans. Diabetes. 2001 Oct;50(10):2349-54. doi: 10.2337/diabetes.50.10.2349.
PubMed 11574419Jackman M, Wendling P, Friars D, Graham TE. Metabolic catecholamine, and endurance responses to caffeine during intense exercise. J Appl Physiol (1985). 1996 Oct;81(4):1658-63. doi: 10.1152/jappl.1996.81.4.1658.
PubMed 8904583Kerr D, Sherwin RS, Pavalkis F, Fayad PB, Sikorski L, Rife F, Tamborlane WV, During MJ. Effect of caffeine on the recognition of and responses to hypoglycemia in humans. Ann Intern Med. 1993 Oct 15;119(8):799-804. doi: 10.7326/0003-4819-119-8-199310150-00005.
PubMed 8379601Kosinski C, Herzig D, Laesser CI, Nakas CT, Melmer A, Vogt A, Vogt B, Laimer M, Bally L, Stettler C. A Single Load of Fructose Attenuates the Risk of Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin: A Randomized, Open-Label, Crossover Proof-of-Principle Study. Diabetes Care. 2020 Sep;43(9):2010-2016. doi: 10.2337/dc19-2250. Epub 2020 Jun 26.
PubMed 32591421Lane W, Bailey TS, Gerety G, Gumprecht J, Philis-Tsimikas A, Hansen CT, Nielsen TSS, Warren M; Group Information; SWITCH 1. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):33-44. doi: 10.1001/jama.2017.7115.
PubMed 28672316
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Combined Caffeine and Carbohydrate Ingestion Counter the Exercise-mediated Fall in Glycaemia in Individuals With Type 1 Diabetes on Insulin Degludec? The DE-CAF Study
- ClinicalTrials.gov ID
- NCT04671043
- Acronym / sponsor ID
- DE-CAF / DE-CAF
- Conditions
- Caffeine and Carbohydrate, Carbohydrate Only, Placebo
- Keywords
- caffeine, type 1 diabetes, exercise, hypoglycemia, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Single-centre, randomised, double-blind crossover design
| Arm | Type | Receives |
|---|---|---|
| CAF+lowCHO | Experimental | Dietary Supplement: Caffeine and glucoseA drink containing caffeine and 10 g rapid-acting carbohydrate (glucose) dissolved in 200 mL of tap water |
| 10g CHO | Active comparator | Dietary Supplement: Glucose aloneA drink containing 10 g rapid-acting carbohydrate (glucose) dissolved in 200 mL of tap water |
| placebo | Placebo comparator | Dietary Supplement: PlaceboA drink containing an artificial sweetener (aspartame) dissolved in 200 mL of tap water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine and glucoseCaffeine and glucose powder dissolved in water | Dietary supplement | CAF+lowCHO |
| Glucose aloneGlucose powder dissolved in water | Dietary supplement | 10g CHO |
| PlaceboArtificial sweetener dissolved in water | Dietary supplement | placebo |
Primary outcome
Hypoglycaemia
Time frame: 60 minutes from start of exercise
Time to hypoglycaemia (plasma glucose <3.9mmol/l) during the 60 min of exercise
11 secondary outcomes
Change in blood glucose concentration
Time frame: 60 minutes from start of exercise
Mean glucose concentration
Time frame: 60 minutes from start of exercise
Area under the glucose curve
Time frame: 60 minutes from start of exercise
%-Time in target glycaemic range during recovery
Time frame: 24 hours
%-Time in target glycaemic range during exercise
Time frame: 60 minutes
Incidence of hypoglycaemia during exercise
Time frame: 60 minutes
Incidence of hypoglycaemia during recovery
Time frame: 24 hours
% Time below target range (< 3.9 mmol/L) during nighttime after exercise
Time frame: 12:00 am until 06:00 am after each exercise visit
% Time below target range (> 10.0 mmol/L) during nighttime after exercise
Time frame: 12:00 am until 06:00 am after each exercise visit
Mean sensor glucose overnight
Time frame: 12:00 am until 06:00 am after each exercise visit
Area under the glucose curve post exercise
Time frame: 30 minutes after stop of exercise
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 14 Mar 2023.
- Background: PubMed 18689694Brazeau AS, Rabasa-Lhoret R, Strychar I, Mircescu H. Barriers to physical activity among patients with type 1 diabetes. Diabetes Care. 2008 Nov;31(11):2108-9. doi: 10.2337/dc08-0720. Epub 2008 Aug 8.
- Background: PubMed 32157790Buzzetti R, Zampetti S, Pozzilli P. Impact of obesity on the increasing incidence of type 1 diabetes. Diabetes Obes Metab. 2020 Jul;22(7):1009-1013. doi: 10.1111/dom.14022. Epub 2020 Mar 24.
- Background: PubMed 26019878Campbell MD, Walker M, Bracken RM, Turner D, Stevenson EJ, Gonzalez JT, Shaw JA, West DJ. Insulin therapy and dietary adjustments to normalize glycemia and prevent nocturnal hypoglycemia after evening exercise in type 1 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 May 12;3(1):e000085. doi: 10.1136/bmjdrc-2015-000085. eCollection 2015.
- Background: PubMed 27926890Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.
- Background: PubMed 723503Costill DL, Dalsky GP, Fink WJ. Effects of caffeine ingestion on metabolism and exercise performance. Med Sci Sports. 1978 Fall;10(3):155-8.
- Background: PubMed 8531542Debrah K, Sherwin RS, Murphy J, Kerr D. Effect of caffeine on recognition of and physiological responses to hypoglycaemia in insulin-dependent diabetes. Lancet. 1996 Jan 6;347(8993):19-24. doi: 10.1016/s0140-6736(96)91557-3.
- Background: PubMed 32174888Dedrick S, Sundaresh B, Huang Q, Brady C, Yoo T, Cronin C, Rudnicki C, Flood M, Momeni B, Ludvigsson J, Altindis E. The Role of Gut Microbiota and Environmental Factors in Type 1 Diabetes Pathogenesis. Front Endocrinol (Lausanne). 2020 Feb 26;11:78. doi: 10.3389/fendo.2020.00078. eCollection 2020.
- Background: PubMed 15334372Francescato MP, Geat M, Fusi S, Stupar G, Noacco C, Cattin L. Carbohydrate requirement and insulin concentration during moderate exercise in type 1 diabetic patients. Metabolism. 2004 Sep;53(9):1126-30. doi: 10.1016/j.metabol.2004.03.015.
- Background: PubMed 19077738Ganio MS, Klau JF, Casa DJ, Armstrong LE, Maresh CM. Effect of caffeine on sport-specific endurance performance: a systematic review. J Strength Cond Res. 2009 Jan;23(1):315-24. doi: 10.1519/JSC.0b013e31818b979a.
- Background: PubMed 11478588Graham TE, Sathasivam P, Rowland M, Marko N, Greer F, Battram D. Caffeine ingestion elevates plasma insulin response in humans during an oral glucose tolerance test. Can J Physiol Pharmacol. 2001 Jul;79(7):559-65.
- Background: PubMed 11574419Greer F, Hudson R, Ross R, Graham T. Caffeine ingestion decreases glucose disposal during a hyperinsulinemic-euglycemic clamp in sedentary humans. Diabetes. 2001 Oct;50(10):2349-54. doi: 10.2337/diabetes.50.10.2349.
- Background: PubMed 8904583Jackman M, Wendling P, Friars D, Graham TE. Metabolic catecholamine, and endurance responses to caffeine during intense exercise. J Appl Physiol (1985). 1996 Oct;81(4):1658-63. doi: 10.1152/jappl.1996.81.4.1658.
- Individual participant dataSharing planned: No
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.
Christoph Stettler, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine and glucose and Glucose alone in people with Caffeine and Carbohydrate and Carbohydrate Only, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 inclusion and 10 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 14 Mar 2023. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Hypoglycaemia (time frame: 60 minutes from start of exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04671043, which also lists 26 linked publications.
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 14 Mar 2023.