The Late Effects of Ethanol Intake on the Glucose Response to Subcutaneous Glucagon in Type 1 Diabetes (ALCO1)

Hvidovre University Hospital

Status and phase

Completed

Phase 4

Conditions

Hypoglycemia

Diabetes Mellitus, Type 1

Treatments

Dietary Supplement: Alcohol

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02881060

H-16027080

Details and patient eligibility

About

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:

To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to restore plasma glucose after an episode of mild hypoglycemia.
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.

Enrollment

12 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

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.