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

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

NCT02516150•Massachusetts General Hospital

Summary

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.

Detailed Description

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. The study will aim to quantify the effect of a blood alcohol content on the anti-hypoglycemic efficacy of glucagon using a hyperinsulinemic -normoglycemic clamp technique in volunteers with type 1 diabetes in a randomized crossover trial.

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (1)

Massachusetts General Hospital Diabetes Research Center

Boston, Massachusetts, United States

Key Dates

Start Date

March 1, 2016

Primary Completion Date

May 1, 2017

Completion Date

June 1, 2017

Last Updated

August 31, 2017

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes Mellitus

Interventions

Ethanol

DRUG

Glucagon

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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