Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec

NCT03497260 | Completed DMC

• 1 other identifier: FruDeg
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus; Diabetes Complications

Keywords

Type 1 Diabetes, Fructose, Exercise, Hypoglycaemia, Degludec

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Glucose levels before exercise

  Time point -30 minutes until time point 0 minutes (initiation of exercise)

• Glucose levels during exercise

  From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia

• Glucose levels after exercise

  From time point 0 minutes until time point 90 minutes

• Lactate levels before exercise

  From time point -30 minutes until time point 0 minutes (initiation of exercise)

• Lactate levels during exercise

  From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia

Study Arms (2)

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

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

Dietary Supplement: Fructose; Other: Plain water

Interventions

Fructose DIETARY_SUPPLEMENT

Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise.

Fructose in water first, water only second; Water only first, Fructose in water second

Plain water OTHER

Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise.

Fructose in water first, water only second; Water only first, Fructose in water second

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32591421 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Complications; Motor Activity; Hypoglycemia

Interventions

Fructose

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)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Christoph Stettler, MD

  Inselspital, Bern University Hospital, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: January 4, 2019
• Primary Completion: September 6, 2019
• Study Completion: September 8, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

CH (1)