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

NCT ID: NCT02881060

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-01-26

Brief 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.

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ethanol

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

Group Type: ACTIVE_COMPARATOR

Alcohol

Intervention Type: DIETARY_SUPPLEMENT

Non-ethanol

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Alcohol

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Cocktail; Mocktail

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Diabetes Academy

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ajenthen Ranjan

MD, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ajenthen Ranjan, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Hvidovre University Hospital

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

H-16027080

Identifier Type: -

Identifier Source: org_study_id