Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03497260
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE April 6, 2018
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE January 4, 2019
Actual Primary Completion Date September 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03497260 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • Lactate levels after exercise [ Time Frame: From time point 0 minutes until time point 90 minutes ]
    Lactate will be measured repeatedly every 5 minutes
  • 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
  • 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
  • Insulin levels after exercise [ Time Frame: From time point 0 minutes until time point 150 minutes ]
    Insulin will be measured repeatedly every 15 minutes
  • 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
  • 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
  • Oxygen consumption before exercise [ Time Frame: Between 15 minutes and 5 minutes before initiation of exercise ]
    Oxygen consumption will be measured via spirometry
  • Oxygen consumption during exercise [ Time Frame: Between 15 minutes and 20 minutes during exercise ]
    Oxygen consumption will be measured via spirometry
  • 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
  • Carbon dioxide production during exercise [ Time Frame: Between 15 minutes and 20 minutes during exercise ]
    Carbon dioxide production will be measured via spirometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec
Official Title  ICMJE Fructose to Reduce Exercise-associated Hypoglycaemia in Individuals With Type 1 Diabetes Treated With Insulin Degludec: Questioning a Paradigm and Offering a Novel Strategy
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Type 1 Diabetes Mellitus
  • Diabetes Complications
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Dietary Supplement: Fructose
    • Other: Plain water
  • 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
    Interventions:
    • Dietary Supplement: Fructose
    • Other: Plain water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2019)
15
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2018)
20
Actual Study Completion Date  ICMJE September 8, 2019
Actual Primary Completion Date September 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03497260
Other Study ID Numbers  ICMJE FruDeg
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christoph Stettler, MD Inselspital, Bern University Hospital, University of Bern
PRS Account University Hospital Inselspital, Berne
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP