Type 1 Diabetes MellitusFruDegNCT03497260
Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec
A study testing Fructose and Plain water in people with Type 1 Diabetes Mellitus and Diabetes Complications, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
To determine and compare the time-to-hypoglycaemia (defined as plasma glucose <3.9mmol/L) in individuals with type 1 diabetes treated with ultra-Long acting insulin degludec during aerobic exercise with or without prior ingestion of a single oral fructose load. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Type 1 Diabetes Mellitus, Diabetes Complications
- What is being tested?
- Fructose and Plain water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jan 2019to 8 Sep 2019
- 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes as defined by the World Health Organization (WHO) for at least 1 year or confirmed negative C-peptide (<100pmol/l with concomitant blood glucose >4 mmol/l)
- Male subjects aged between 18-45 years
- HbA1c <8.0% (64mmol/mol) based on analysis from the central laboratory unit of the University Hospital Bern.
- Basal/Bolus-insulin regimen with insulin degludec for at least 3 months, with good knowledge of insulin self-management
- Regular physical activity (at least 30 min of moderate exercise 3 times weekly)
- Written informed consent
Who cannot join
- Relevant diabetic complications as judged by the investigator
- Total daily insulin dose >2 IU/kg/day
- Hypoglycaemia unawareness (Gold score > 4) or any episode of severe hypoglycaemia as defined by the American Diabetes Association within the last 6 months
- Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Current treatment with drugs known to interfere with metabolism, e.g. systemic corticosteroids, statins etc.
- Known fructose-intolerance or malabsorption
- Known allergy to one of the study drugs
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital
Bern, 3010
About this study
Official title: Fructose to Reduce Exercise-associated Hypoglycaemia in Individuals With Type 1 Diabetes Treated With Insulin Degludec: Questioning a Paradigm and Offering a Novel Strategy
To determine and compare the time-to-hypoglycaemia (defined as plasma glucose <3.9mmol/L) in individuals with type 1 diabetes treated with ultra-Long acting insulin degludec during aerobic exercise with or without prior ingestion of a single oral fructose load.
Read the detailed description
Glycaemic control remains complex and demanding during exercise for type 1 diabetes (T1D) patients. Traditional treatment guidelines for exercise emphasizing the reduction of insulin doses and/or ingestion of additional carbohydrates are of limited applicability for patients treated with ultra-long acting basal insulin analogues. Dose reductions may require two to three days for modern basal insulin analogues in order to achieve an adapted steady state, hereby increasing the risk of inadequate insulin-following exercise. If T1D patients engage in recreational exercise - as recommended by every international treatment guideline - current treatment strategies may simply not be sufficient.
As a consequence for patients treated with modern basal insulin analogues, it seems more adequate not to modify insulin doses but to apply alternative strategies for recreational exercise. The ingestion of fructose, an insulin-independent carbohydrate, which increases lipid oxidation but attenuates the dependency on carbohydrates may offer a novel strategy. Up to date, only preliminary data for fructose have been produced regarding clinical effectiveness and underlying mechanisms in the prevention of hypoglycaemia. The present comprehensive study aims to investigate the clinical efficacy, feasibility, and safety of a pre-exercise oral fructose load without modification of insulin degludec in T1D patients.
- Conditions
- Type 1 Diabetes Mellitus, Diabetes Complications
- Being tested
- Fructose, Plain water
- Keywords
- Type 1 Diabetes, Fructose, Exercise, Hypoglycaemia, Degludec
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Complications, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructoseDietary supplement
Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
Plain waterOther
Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
| Study group | Role | What they receive |
|---|---|---|
| Fructose in water first, water only second | Experimental | Intake of 20 g of fructose dissolved in 200 ml of tap water at first visit; intake of 200 ml of tap water at second visit Receives: Dietary Supplement: Fructose; Other: Plain water |
| Water only first, Fructose in water second | Experimental | Intake of 200 ml of tap water at first visit; intake of 200 ml of 20 g of fructose dissolved in 200 ml of tap water at second visit Receives: Dietary Supplement: Fructose; Other: Plain water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l)
The development of hypoglycaemia will be determined by repeated measurement of plasma glucose.
Measured: From time point 0 minutes (initiation of exercise) to time point 60 minutes (completion of exercise) or development of hypoglycaemia
Secondary outcomes (15)
Glucose levels before exercise
Plasma glucose will be measured repeatedly every 5 minutes
Measured: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Glucose levels during exercise
Plasma glucose will be measured repeatedly every 5 minutes
Measured: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Glucose levels after exercise
Plasma glucose will be measured repeatedly every 5 minutes
Measured: From time point 0 minutes until time point 90 minutes
Lactate levels before exercise
Lactate will be measured repeatedly every 5 minutes
Measured: From time point -30 minutes until time point 0 minutes (initiation of exercise)
Lactate levels during exercise
Lactate will be measured repeatedly every 5 minutes
Measured: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Lactate levels after exercise
Lactate will be measured repeatedly every 5 minutes
Measured: From time point 0 minutes until time point 90 minutes
Insulin levels before exercise
Lactate will be measured repeatedly every 15 minutes
Measured: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Insulin levels during exercise
Insulin will be measured repeatedly every 15 minutes
Measured: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Insulin levels after exercise
Insulin will be measured repeatedly every 15 minutes
Measured: From time point 0 minutes until time point 150 minutes
Heart rate before exercise
Heart rate will be measured using an electro-cardio-gramme
Measured: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Heart rate during exercise
Heart rate will be measured using an electro-cardio-gramme
Measured: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Oxygen consumption before exercise
Oxygen consumption will be measured via spirometry
Measured: Between 15 minutes and 5 minutes before initiation of exercise
Oxygen consumption during exercise
Oxygen consumption will be measured via spirometry
Measured: Between 15 minutes and 20 minutes during exercise
Carbon dioxide production before exercise
Carbon dioxide production will be measured via spirometry
Measured: Between 15 minutes and 5 minutes before initiation of exercise
Carbon dioxide production during exercise
Carbon dioxide production will be measured via spirometry
Measured: Between 15 minutes and 20 minutes during exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start4 Jan 2019
- Primary completion6 Sep 2019
- Study completion8 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 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, Inselspital, Bern University Hospital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497260
- Sponsor's protocol ID
- FruDeg
- Acronym
- FruDeg
- Status last verified
- Sep 2019
- First submitted
- 6 Apr 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kosinski 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 32591421
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose to Reduce Exercise-associated Hypoglycaemia in Individuals With Type 1 Diabetes Treated With Insulin Degludec: Questioning a Paradigm and Offering a Novel Strategy
- ClinicalTrials.gov ID
- NCT03497260
- Acronym / sponsor ID
- FruDeg / FruDeg
- Conditions
- Type 1 Diabetes Mellitus, Diabetes Complications
- Keywords
- Type 1 Diabetes, Fructose, Exercise, Hypoglycaemia, Degludec
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 8 Sep 2019 (actual)
- First posted
- 13 Apr 2018 (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.
To determine and compare the time-to-hypoglycaemia (defined as plasma glucose <3.9mmol/L) in individuals with type 1 diabetes treated with ultra-Long acting insulin degludec during aerobic exercise with or without prior ingestion of a single oral fructose load.
Detailed description
Glycaemic control remains complex and demanding during exercise for type 1 diabetes (T1D) patients. Traditional treatment guidelines for exercise emphasizing the reduction of insulin doses and/or ingestion of additional carbohydrates are of limited applicability for patients treated with ultra-long acting basal insulin analogues. Dose reductions may require two to three days for modern basal insulin analogues in order to achieve an adapted steady state, hereby increasing the risk of inadequate insulin-following exercise. If T1D patients engage in recreational exercise - as recommended by every international treatment guideline - current treatment strategies may simply not be sufficient.
As a consequence for patients treated with modern basal insulin analogues, it seems more adequate not to modify insulin doses but to apply alternative strategies for recreational exercise. The ingestion of fructose, an insulin-independent carbohydrate, which increases lipid oxidation but attenuates the dependency on carbohydrates may offer a novel strategy. Up to date, only preliminary data for fructose have been produced regarding clinical effectiveness and underlying mechanisms in the prevention of hypoglycaemia. The present comprehensive study aims to investigate the clinical efficacy, feasibility, and safety of a pre-exercise oral fructose load without modification of insulin degludec in T1D patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fructose in water first, water only second | Experimental | Dietary Supplement: Fructose, Other: Plain waterIntake of 20 g of fructose dissolved in 200 ml of tap water at first visit; intake of 200 ml of tap water at second visit |
| Water only first, Fructose in water second | Experimental | Dietary Supplement: Fructose, Other: Plain waterIntake of 200 ml of tap water at first visit; intake of 200 ml of 20 g of fructose dissolved in 200 ml of tap water at second visit |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Type 1 diabetes as defined by the World Health Organization (WHO) for at least 1 year or confirmed negative C-peptide (<100pmol/l with concomitant blood glucose >4 mmol/l)
- Male subjects aged between 18-45 years
- HbA1c <8.0% (64mmol/mol) based on analysis from the central laboratory unit of the University Hospital Bern.
- Basal/Bolus-insulin regimen with insulin degludec for at least 3 months, with good knowledge of insulin self-management
- Regular physical activity (at least 30 min of moderate exercise 3 times weekly)
Key exclusion criteria (7 listed)
- Relevant diabetic complications as judged by the investigator
- Total daily insulin dose >2 IU/kg/day
- Hypoglycaemia unawareness (Gold score > 4) or any episode of severe hypoglycaemia as defined by the American Diabetes Association within the last 6 months
- Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Current treatment with drugs known to interfere with metabolism, e.g. systemic corticosteroids, statins etc.
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 |
|---|---|---|
| FructoseIntake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise. | Dietary supplement | Fructose in water first, water only second, Water only first, Fructose in water second |
| Plain waterIntake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise. | Other | Fructose in water first, water only second, Water only first, Fructose in water second |
Primary outcome
Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l)
Time frame: From time point 0 minutes (initiation of exercise) to time point 60 minutes (completion of exercise) or development of hypoglycaemia
The development of hypoglycaemia will be determined by repeated measurement of plasma glucose.
15 secondary outcomes
Glucose levels before exercise
Time frame: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Glucose levels during exercise
Time frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Glucose levels after exercise
Time frame: From time point 0 minutes until time point 90 minutes
Lactate levels before exercise
Time frame: From time point -30 minutes until time point 0 minutes (initiation of exercise)
Lactate levels during exercise
Time frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Lactate levels after exercise
Time frame: From time point 0 minutes until time point 90 minutes
Insulin levels before exercise
Time frame: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Insulin levels during exercise
Time frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Insulin levels after exercise
Time frame: From time point 0 minutes until time point 150 minutes
Heart rate before exercise
Time frame: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Heart rate during exercise
Time frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Oxygen consumption before exercise
Time frame: Between 15 minutes and 5 minutes before initiation of exercise
Oxygen consumption during exercise
Time frame: Between 15 minutes and 20 minutes during exercise
Carbon dioxide production before exercise
Time frame: Between 15 minutes and 5 minutes before initiation of exercise
Carbon dioxide production during exercise
Time frame: Between 15 minutes and 20 minutes during 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 20 Sep 2019.
- Derived from this study: PubMed 32591421Kosinski 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.
- Individual participant dataSharing planned: Undecided
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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
Inselspital, Bern University Hospital, 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 Fructose and Plain water in people with Type 1 Diabetes Mellitus and Diabetes Complications, 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 6 inclusion and 7 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 20 Sep 2019. 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. 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?
Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l) (time frame: From time point 0 minutes (initiation of exercise) to time point 60 minutes (completion of exercise) or development of hypoglycaemia). 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 NCT03497260, which also lists 1 linked publication.
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 20 Sep 2019.