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Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec (FruDeg)

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ClinicalTrials.gov Identifier: NCT03497260
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Diabetes Complications Dietary Supplement: Fructose Other: Plain water Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fructose in water first, water only second
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
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.

Experimental: Water only first, Fructose in water second
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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Glucose levels before exercise [ Time Frame: Time point -30 minutes until time point 0 minutes (initiation of exercise) ]
    Plasma glucose will be measured repeatedly every 5 minutes

  2. Glucose levels during exercise [ Time Frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia ]
    Plasma glucose will be measured repeatedly every 5 minutes

  3. Glucose levels after exercise [ Time Frame: From time point 0 minutes until time point 90 minutes ]
    Plasma glucose will be measured repeatedly every 5 minutes

  4. Lactate levels before exercise [ Time Frame: From time point -30 minutes until time point 0 minutes (initiation of exercise) ]
    Lactate will be measured repeatedly every 5 minutes

  5. Lactate levels during exercise [ Time Frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia ]
    Lactate will be measured repeatedly every 5 minutes

  6. Lactate levels after exercise [ Time Frame: From time point 0 minutes until time point 90 minutes ]
    Lactate will be measured repeatedly every 5 minutes

  7. Insulin levels before exercise [ Time Frame: Time point -30 minutes until time point 0 minutes (initiation of exercise) ]
    Lactate will be measured repeatedly every 15 minutes

  8. Insulin levels during exercise [ Time Frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia ]
    Insulin will be measured repeatedly every 15 minutes

  9. Insulin levels after exercise [ Time Frame: From time point 0 minutes until time point 150 minutes ]
    Insulin will be measured repeatedly every 15 minutes

  10. Heart rate before exercise [ Time Frame: Time point -30 minutes until time point 0 minutes (initiation of exercise) ]
    Heart rate will be measured using an electro-cardio-gramme

  11. Heart rate during exercise [ Time Frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia ]
    Heart rate will be measured using an electro-cardio-gramme

  12. Oxygen consumption before exercise [ Time Frame: Between 15 minutes and 5 minutes before initiation of exercise ]
    Oxygen consumption will be measured via spirometry

  13. Oxygen consumption during exercise [ Time Frame: Between 15 minutes and 20 minutes during exercise ]
    Oxygen consumption will be measured via spirometry

  14. Carbon dioxide production before exercise [ Time Frame: Between 15 minutes and 5 minutes before initiation of exercise ]
    Carbon dioxide production will be measured via spirometry

  15. Carbon dioxide production during exercise [ Time Frame: Between 15 minutes and 20 minutes during exercise ]
    Carbon dioxide production will be measured via spirometry



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497260


Contacts
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Contact: Lia Bally, MD PhD + 41 31 632 40 70 lia.bally@insel.ch
Contact: Andreas Melmer, MD PhD + 41 31 632 40 70 Andreas.Melmer@insel.ch

Locations
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Switzerland
Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Principal Investigator: Christoph Stettler, Professor, MD         
Sub-Investigator: Lia Bally, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Christoph Stettler, MD Inselspital, Bern University Hospital, University of Bern

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03497260     History of Changes
Other Study ID Numbers: FruDeg
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Inselspital, Berne:
Type 1 Diabetes, Fructose, Exercise, Hypoglycaemia, Degludec

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases