Skip to content

Trial · Interventional

CompletedPhase 4Results postedRegistry data

Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon

NCTNCT02516150 (opens ClinicalTrials.gov in a new tab)Other id2015P001323
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
26 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2016
Primary completion
May 2017
Completion
Jun 2017
First posted
5 Aug 2015 (estimated)
Last update posted
31 Aug 2017
Conditions
Type 1 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 4

    Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon

    NCT02516150

    Mar 2016 to Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with type 1 diabetes.

Interventions

  • EthanolDrug
  • GlucagonDrug

Arms2

  • Experimental

    Glucagon with Ethanol

    Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.

  • Active comparator

    Glucagon without Ethanol

    Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. AOCGIR (Area Over the Curve for Glucose Infusion Rate)

    Time frame · 1 Day Visit (approximately 8 to 11 hours)

    Registry description

    Area over the curve for the glucose infusion rate in the hour following a subcutaneous glucagon dose with a blood alcohol content of 0 vs 0.1%

Secondary outcomes(1)

  1. Maximum Change in GIR (Glucose Infusion Rate) From Baseline

    Time frame · 1 Day Visit (approximately 8 to 11 hours)

    Registry description

    This outcome is measuring the maximum change in the glucose infusion rate from the GIR at the time of the injection through the 90 minutes after the glucagon injection in the presence and absence of ethanol. The glucose infusion rate is adjusted up to every two minutes throughout the clamp, and for 90 minutes total after the glucagon injection.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 1 Day Visit (approximately 8 to 11 hours)

AOCGIR (Area Over the Curve for Glucose Infusion Rate)

GroupValue (mg*minute/dl)Spread
Glucagon With Ethanol19961259
Glucagon Without Ethanol1981938
Secondary and other outcome results(1)
Secondary outcomeMean· 1 Day Visit (approximately 8 to 11 hours)

Maximum Change in GIR (Glucose Infusion Rate) From Baseline

GroupValue (ml/hour)Spread
Glucagon With Ethanol83.035.2
Glucagon Without Ethanol101.738.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Glucagon With EthanolVolunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection. Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1% Glucagon: injection of 50 micrograms of glucagon0 / 150 / 153 / 15
Glucagon Without EthanolVolunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection. Glucagon: injection of 50 micrograms of glucagon0 / 150 / 150 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
* Inclusion Criteria: * Age 21 to 80 years old with type 1 diabetes for at least one year. * Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), or insulin glulisine (Apidra) for at least one week prior to enrollment. * Alcohol exposure on at least one occasion in the last year consisting of at least 4 drinks in one sitting. * Exclusion Criteria: * Unable to provide informed consent. * Unable to comply with study procedures. * Unable to refrain from the consumption of alcohol at least 24 hours prior to study start. * Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject. * Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception. * Aldehyde dehydrogenase deficiency as determined by a screening questionnaire * End stage renal disease on dialysis (hemodialysis or peritoneal dialysis). * History of pheochromocytoma (because glucagon has been reported to precipitate hypertensive crisis in the setting of pheochromocytoma). Fractionated metanephrines will be tested in patients with a history increasing the risk for a catecholamine secreting tumor: * Paroxysms of tachycardia, pallor, or headache. Personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease, Episodic or treatment of refractory (requiring 4 or more medications to achieve normotension) hypertension. * History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache. * Inadequate venous access as determined by study nurse or physician at time of screening. * Liver failure or cirrhosis * Hemoglobin \< 12 gm/dl. * History of problem drinking 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 * Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.

PepBank is a research reference. Talk to a doctor before you use any peptide.