Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec

Type 1 Diabetes Mellitus Clinical Trial

— FruDeg  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497260
• Other study ID #: FruDeg
• Status: Completed
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: September 8, 2019

Study information

• Verified date: September 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 8, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Dietary Supplement:
• Fructose
Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise.

Other:
• Plain water
Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise.

Locations

Country	Name	City	State
Switzerland	Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l)	The development of hypoglycaemia will be determined by repeated measurement of plasma glucose.	From time point 0 minutes (initiation of exercise) to time point 60 minutes (completion of exercise) or development of hypoglycaemia
Secondary	Glucose levels before exercise	Plasma glucose will be measured repeatedly every 5 minutes	Time point -30 minutes until time point 0 minutes (initiation of exercise)
Secondary	Glucose levels during exercise	Plasma glucose will be measured repeatedly every 5 minutes	From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Secondary	Glucose levels after exercise	Plasma glucose will be measured repeatedly every 5 minutes	From time point 0 minutes until time point 90 minutes
Secondary	Lactate levels before exercise	Lactate will be measured repeatedly every 5 minutes	From time point -30 minutes until time point 0 minutes (initiation of exercise)
Secondary	Lactate levels during exercise	Lactate will be measured repeatedly every 5 minutes	From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Secondary	Lactate levels after exercise	Lactate will be measured repeatedly every 5 minutes	From time point 0 minutes until time point 90 minutes
Secondary	Insulin levels before exercise	Lactate will be measured repeatedly every 15 minutes	Time point -30 minutes until time point 0 minutes (initiation of exercise)
Secondary	Insulin levels during exercise	Insulin will be measured repeatedly every 15 minutes	From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Secondary	Insulin levels after exercise	Insulin will be measured repeatedly every 15 minutes	From time point 0 minutes until time point 150 minutes
Secondary	Heart rate before exercise	Heart rate will be measured using an electro-cardio-gramme	Time point -30 minutes until time point 0 minutes (initiation of exercise)
Secondary	Heart rate during exercise	Heart rate will be measured using an electro-cardio-gramme	From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Secondary	Oxygen consumption before exercise	Oxygen consumption will be measured via spirometry	Between 15 minutes and 5 minutes before initiation of exercise
Secondary	Oxygen consumption during exercise	Oxygen consumption will be measured via spirometry	Between 15 minutes and 20 minutes during exercise
Secondary	Carbon dioxide production before exercise	Carbon dioxide production will be measured via spirometry	Between 15 minutes and 5 minutes before initiation of exercise
Secondary	Carbon dioxide production during exercise	Carbon dioxide production will be measured via spirometry	Between 15 minutes and 20 minutes during exercise