An interventional study of Fructose and Plain water in Type 1 Diabetes Mellitus and Diabetes Complications, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-09-20.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Supportive care
Among 16 studies in Diabetes Mellitus, Type 1 by Insel Gruppe AG, University Hospital Bern — none open to participants now, none under way, none of them phase 3. Diabetes Mellitus, Type 1 · Insel Gruppe AG, University Hospital Bern.
Among the 16 studies in Diabetes Mellitus, Type 1 by Insel Gruppe AG, University Hospital Bern, this one is the 7th largest by enrollment of the 13 interventional ones that give a count, is one of 4 that started in 2019, is one of 10 with no phase, and was the 4th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →None of the 16 studies in Diabetes Mellitus, Type 1 by Insel Gruppe AG, University Hospital Bern is open now.
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 45 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 4 started in 2019.
This study's enrollment of 15 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 15 across the 13 interventional studies, 30 across the 3 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Diabetes Mellitus, Type 1 by Insel Gruppe AG, University Hospital Bern, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Dietary Supplement: Fructose · Other: Plain water
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
Dietary Supplement: Fructose · Other: Plain water
Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l)
The development of hypoglycaemia will be determined by repeated measurement of plasma glucose.
Time frame: From time point 0 minutes (initiation of exercise) to time point 60 minutes (completion of exercise) or development of hypoglycaemia
Glucose levels before exercise
Plasma glucose will be measured repeatedly every 5 minutes
Time frame: 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
Time frame: 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
Time frame: From time point 0 minutes until time point 90 minutes
Lactate levels before exercise
Lactate will be measured repeatedly every 5 minutes
Time frame: 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
Time frame: 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
Time frame: From time point 0 minutes until time point 90 minutes
Insulin levels before exercise
Lactate will be measured repeatedly every 15 minutes
Time frame: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Insulin levels during exercise
Insulin will be measured repeatedly every 15 minutes
Time frame: 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
Time frame: From time point 0 minutes until time point 150 minutes
Heart rate before exercise
Heart rate will be measured using an electro-cardio-gramme
Time frame: 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
Time frame: 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
Time frame: Between 15 minutes and 5 minutes before initiation of exercise
Oxygen consumption during exercise
Oxygen consumption will be measured via spirometry
Time frame: Between 15 minutes and 20 minutes during exercise
Carbon dioxide production before exercise
Carbon dioxide production will be measured via spirometry
Time frame: Between 15 minutes and 5 minutes before initiation of exercise
Carbon dioxide production during exercise
Carbon dioxide production will be measured via spirometry
Time frame: Between 15 minutes and 20 minutes during exercise
Plan to share: Undecided
Ran from Jan 2019 to primary completion in Sep 2019, 8 months.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 8 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fructose
Insel Gruppe AG, University Hospital Bern →