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

NCT ID: NCT02516150

Last Updated: 2017-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-06-30

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ethanol

Intervention Type: DRUG

IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%

Glucagon

Intervention Type: DRUG

injection of 50 micrograms of glucagon

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.

Group Type: ACTIVE_COMPARATOR

Glucagon

Intervention Type: DRUG

injection of 50 micrograms of glucagon

Interventions

Ethanol

IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%

Intervention Type: DRUG

Glucagon

injection of 50 micrograms of glucagon

Intervention Type: DRUG

Other Intervention Names

Ethyl Alcohol; Alcohol

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven J. Russell, MD, PhD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven J Russell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Diabetes Research Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015P001323

Identifier Type: -

Identifier Source: org_study_id