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

NCT02881060 | Completed Phase 4

• 1 other identifier: H-16027080
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 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. 2.To determine the late effects of ethanol on the counter-regulatory hormones and hypoglycaemia awareness during mild hypoglycaemia

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Keywords

Glucagon; Ethanol

Outcome Measures

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.

  0-120 min after the first glucagon injection

Secondary Outcomes (58)

• Peak plasma glucose

  0-240 min after the first glucagon injection

• Increase in plasma glucose

  0-120 min after the second glucagon injection

• Total AUC(0-120)

  0-240 min after the first glucagon injection

• PI-AUC(0-120)

  0-240 min after the first glucagon injection

• Tmax

  0-240 min after the first glucagon injection

Study Arms (2)

Ethanol

ACTIVE COMPARATOR

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

Non-ethanol

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Alcohol DIETARY_SUPPLEMENT

Also known as: Cocktail

Ethanol

Placebo DIETARY_SUPPLEMENT

Also known as: Mocktail

Non-ethanol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Danish Diabetes Academy: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Ajenthen Ranjan, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: January 26, 2017
• Study Completion: January 26, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

DK (1)