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CompletedNCT02881060ALCO1Updated Jul 24, 2017

The Late Effects of Ethanol Intake on the Glucose Response to Subcutaneous Glucagon in Type 1 Diabetes

A Phase 4 interventional study of Alcohol and Placebo in Hypoglycemia and Diabetes Mellitus, Type 1, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-24.

Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the dual hormone treatment in preventing hypoglycaemia.

The purpose of this study is to determine, whether ethanol influences the glucose response to subcutaneous glucagon during mild hypoglycaemia.

The investigators hypothesize that prior evening ethanol consumption does not reduce the effect of a glucagon bolus to raise plasma glucose compared with no prior ethanol consumption.

The study aims:

  1. To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to restore plasma glucose after an episode of mild hypoglycemia.
  2. To determine the late effects of ethanol on the counter-regulatory hormones and hypoglycaemia awareness during mild hypoglycaemia

A double-blinded placebo-controlled study will be conducted. Participants will serve as their own controls. Eligible participants will after an informed consent complete two study visits, one with and one without ethanol consumption, in a random order. On each study visit, participants are induced a insulin induced hypoglycemia, seven-eight hours after a meal with or without ethanol. Once plasma glucose is below 3.9 mmol/l, a subcutaneous injection of 100 mcg glucagon is administered. Two hours later a second bolus is administered.

02

Conditions studied

  • Hypoglycemia
  • Diabetes Mellitus, Type 1

Keywords

  • Glucagon
  • Ethanol
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 12 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 - 70 years
  • T1D ≥ 3 year
  • BMI 20-28 kg/m2
  • CSII ≥ 1 year
  • Caucasian origin
  • Hypoglycaemia awareness (assessed by Gold, Clarke and Pedersen-Bjergaard methods)
  • Use of carbohydrate counting and the insulin pump bolus calculator for all meals
  • Ethanol exposure once within 1 year consisting of at least 4 drinks (1 drink contains 12 gram ethanol) within four hours

Exclusion criteria

Exclusion Criteria:

  • Allergy or intolerance to lactose or Glucagen®(Novo Nordisk, Bagsværd, DK)
  • Allergy for ethanol or any food ingredients that will be used in the study.
  • Impaired renal function (eGFR \< 60 ml/min/1.73m2)
  • Liver disease with ALAT > 2.5 times the upper limit of the reference interval
  • Gastropareses (beat-beat variation \< 10 beats per min and/or orthostatic systolic blood pressure > 20 mmHg)
  • Insomnia, sleep apnoea or any troubles with sleeping that according to the investigator's assessment makes the individual unsuitable for study participation.
  • Aldehyde dehydrogenase deficiency as determined by a screening questionnaire
  • Unable to refrain from the consumption of ethanol at least 24 hours prior to study start
  • History of drinking problems or alcoholism, regardless of whether active or in remission.
  • Use of benzodiazepines or barbiturates or opiates or other central nervous system depressant drugs that could act synergistically with ethanol to lower the level of consciousness
  • History of drug abuse
  • Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject.
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
  • Use of medications that are known to cause QT interval prolongation
  • Presence of pheochromocytoma
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation
  • Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
  • Females who have different basal insulin pattern depending on their menstrual cycle.
  • Inability to understand the individual information and to give informed consent.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Ethanol

    Drinking a cocktail of ethanol (0.8 g ethanol per kg body weight), diet lemonade and water of 1:1:1 (volume distribution).

    Dietary Supplement: Alcohol

  • Placebo comparator
    Non-ethanol

    Drinking a cocktail of diet lemonade and water of 1:2 (volume distribution).

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementAlcohol

    Also known as: Cocktail

  • Dietary supplementPlacebo

    Also known as: Mocktail

06

What researchers measure

Primary outcomes

  1. Increase in plasma glucose

    The primary endpoint is difference in increase in plasma glucose value after the first injection of 100 µg s.c. glucagon on study nights with ethanol vs. study nights without ethanol consumption.

    Time frame: 0-120 min after the first glucagon injection

Secondary outcomes

  1. Peak plasma glucose

    Maximal plasma glucose after the first and second glucagon injection

    Time frame: 0-240 min after the first glucagon injection

  2. Increase in plasma glucose

    Increase in plasma glucose caused by the second glucagon injection.

    Time frame: 0-120 min after the second glucagon injection

  3. Total AUC(0-120)

    Total area under the glucose curve from 0-120 minutes after each glucagon injection

    Time frame: 0-240 min after the first glucagon injection

  4. PI-AUC(0-120)

    positive incremental area under the glucose curve from 0-120 minutes after each glucagon injection

    Time frame: 0-240 min after the first glucagon injection

  5. Tmax

    Time-to-peak glucose value after each glucagon injection glucagon injection

    Time frame: 0-240 min after the first glucagon injection

  6. Time above 4.0mM

    Duration of glucose above 4.0 mmol/l after first and second glucagon injection

    Time frame: 0-240 min after the first glucagon injection

  7. Time above baseline

    Duration of glucose above baseline after first and second glucagon injection

    Time frame: 0-240 min after the first glucagon injection

  8. Rescue rates

    Numbers of first and second glucagon injections that raises PG \> 4.9 mmol/l

    Time frame: 0-240 min after the first glucagon injection

  9. Hyperglycemia rates

    Number of first and second glucagon injections that raises PG \> 7.1 mmol/l

    Time frame: 0-240 min after the first glucagon injection

  10. Changes in plasma ketone bodies, measured as area under the curve

    Time frame: 0-240 min after the first glucagon injection

  11. Changes in plasma ketone bodies, measured as incremental peak

    Time frame: 0-240 min after the first glucagon injection

  12. Changes in plasma glucagon, measured as area under the curve

    Time frame: 0-240 min after the first glucagon injection

  13. Changes in plasma glucagon, measured as incremental peak

    Time frame: 0-240 min after the first glucagon injection

  14. Changes in insulin, measured as area under the curve

    Time frame: 0-240 min after the first glucagon injection

  15. Changes in insulin, measured as incremental peak

    Time frame: 0-240 min after the first glucagon injection

  16. Changes in growth hormones, measured as area under the curve

    Time frame: 0-240 min after the first glucagon injection

  17. Changes in growth hormones, measured as incremental peak

    Time frame: 0-240 min after the first glucagon injection

  18. Changes in serum corticole, measured as area under the curve

    Time frame: 0-240 min after the first glucagon injection

  19. Changes in serum corticole, measured as incremental peak

    Time frame: 0-240 min after the first glucagon injection

  20. Changes in plasma ethanol, measured as area under the curve

    Time frame: 0-240 min after the first glucagon injection

  21. Changes in plasma ethanol, measured as incremental peak

    Time frame: 0-240 min after the first glucagon injection

  22. Changes in free fatty acids, measured as area under the curve

    Time frame: 0-240 min after the first glucagon injection

  23. Changes in free fatty acids, measured as incremental peak

    Time frame: 0-240 min after the first glucagon injection

  24. Changes in triglycerides, measured as area under the curve

    Time frame: 0-240 min after the first glucagon injection

  25. Changes in triglycerides, measured as incremental peak

    Time frame: 0-240 min after the first glucagon injection

  26. Average in blood pressure

    Time frame: 0-240 min after the first glucagon injection

  27. Average heart rate

    Time frame: 0-240 min after the first glucagon injection

  28. Intensity of hypoglycemia

    Average changes in Edinburgh Hypoglycaemia Scale over time during insulin and glucagon phase

    Time frame: 0-240 min after the first glucagon injection

  29. Cognitive impairment

    Average scores in cognitive test 30 min before each glucagon injection.

    Time frame: 0-240 min after the first glucagon injection

  30. Side effects

    Average visual analogue scale score from 0-180 min for nausea and headache after glucagon injection

    Time frame: 0-240 min after the first glucagon injection

  31. Incidence of vomiting

    Incidence of vomiting after 0-4 hours after each glucagon injection.

    Time frame: 0-240 min after the first glucagon injection

  32. Meal induced glucose excursion

    Total and incremental area under the glucose curve from 0-120 and 0-240 min after eating the mixed meal

    Time frame: 0-3 hours after meal

  33. Meal induced hormonal changes

    Total and incremental area under the glucose curve from 0-120 and 0-240 min after eating the mixed meal

    Time frame: 0-3 hours after meal

  34. Nocturnal changes in plasma glucose

    Area under the curve during sleep

    Time frame: 0-6 hours after start of sleep

  35. Nocturnal changes in corticol

    Area under the curve during sleep

    Time frame: 0-6 hours after start of sleep

  36. Nocturnal changes in growth hormone

    Area under the curve during sleep

    Time frame: 0-6 hours after start of sleep

  37. Nocturnal changes in ketones

    Area under the curve during sleep

    Time frame: 0-6 hours after start of sleep

  38. Nocturnal changes in ethanol

    Area under the curve during sleep

    Time frame: 0-6 hours after start of sleep

  39. Nocturnal changes in glucagon

    Area under the curve during sleep

    Time frame: 0-6 hours after start of sleep

  40. Difference between the first second glucagon injection and between both study visits in peak change plasma glucose

    Time frame: 0-240 min after the first glucagon injection

  41. Difference between glucagon injections on both study visits in positive incremental area under the glucose curve from 0-120 minutes

    Time frame: 0-240 min after the first glucagon injection

  42. Difference between glucagon injections on both study visits in total area under the glucose curve from 0-120 minutes

    Time frame: 0-240 min after the first glucagon injection

  43. Difference between glucagon injections on both study visits in time-to-peak glucose value

    Time frame: 0-240 min after the first glucagon injection

  44. Difference between glucagon injections on both study visits in duration of glucose above 4.0 mmol/l after first and second glucagon injection

    Time frame: 0-240 min after the first glucagon injection

  45. Difference between glucagon injections on both study visits in duration of glucose above baseline after first and second glucagon injection

    Time frame: 0-240 min after the first glucagon injection

  46. Difference in glucose sensor data on study night with alcohol vs. study night without alcohol - Mean absolute relative difference (MARD) values of glucose sensors compared with YSI from 7 PM- 8 AM.

    Intentions to treat analysis

    Time frame: 0-10 hours after meal

  47. Difference in glucose sensor data on study night with alcohol vs. study night without alcohol - Precision absolute relative difference (PARD) 120 min before and 120 after each glucagon injection.

    Intentions to treat analysis

    Time frame: 0-10 hours after meal

  48. Difference in glucose sensor data on study night with alcohol vs. study night without alcohol - MARD values between glucose sensors 0-120 minutes after each glucagon injection.

    Intentions to treat analysis

    Time frame: 0-10 hours after meal

  49. Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Time in range (glucose sensor value =4.0-10.0mmol/l)

    Intentions to treat analysis

    Time frame: 0-2 days after the first glucagon injection

  50. Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Time in hypoglycaemia (glucose sensor value < 4.0 mmol/l)

    Intentions to treat analysis

    Time frame: 0-2 days after the first glucagon injection

  51. Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Time in hyperglycaemia (glucose sensor value >10.0mmol/l)

    Intentions to treat analysis

    Time frame: 0-2 days after the first glucagon injection

  52. Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Number of hypoglycaemia episodes (glucose sensor value < 4.0 mmol/l)

    Intentions to treat analysis

    Time frame: 0-2 days after the first glucagon injection

  53. Difference in glucose sensor data between the study period with and without alcohol - Clarke- Error Grid analysis for both sensors compared with YSI during study visit

    Intentions to treat analysis

    Time frame: -2 to 4 days after study visits

  54. Difference in glucose sensor data between the study period with and without alcohol - PARD values from day 1-7

    Intentions to treat analysis

    Time frame: -2 to 4 days after study visits

  55. Difference in glucose sensor data between the study period with and without alcohol - PARD values <4.0 mmol/L from day 1-7

    Intentions to treat analysis

    Time frame: -2 to 4 days after study visits

  56. Difference in glucose sensor data between the study period with and without alcohol - PARD values 4.0-10.0 mmol/L from day 1-7

    Intentions to treat analysis

    Time frame: -2 to 4 days after study visits

  57. Difference in glucose sensor data between the study period with and without alcohol PARD values >10.0 mmol/L from day 1-7

    Intentions to treat analysis

    Time frame: -2 to 4 days after study visits

  58. Difference in glucose sensor data between the study period with and without alcohol - Number of hypoglycaemia episodes (glucose sensor value < 4.0 mmol/l)

    Intentions to treat analysis

    Time frame: -2 to 4 days after study visits

07

Study locations

1 site
  • Hvidovre University Hospital
    Hvidovre, 2650, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02881060
Lead sponsor
Hvidovre University Hospital
Collaborators
Danish Diabetes Academy, University of Copenhagen
Responsible party
Ajenthen Ranjan (MD, PhD student, Hvidovre University Hospital) — Principal investigator
First posted
Aug 26, 2016
Start date
Aug 2016
Primary completion
Jan 26, 2017
Completion
Jan 26, 2017
Last update
Jul 24, 2017

Study contacts

Ajenthen Ranjan, MD
principal investigator · Hvidovre University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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