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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02516150
• Other study ID #: 2015P001323
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 28, 2015
• Last updated: July 6, 2017
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Ethanol
IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%
• Glucagon
injection of 50 micrograms of glucagon

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Diabetes Research Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOCGIR (Area Over the Curve for Glucose Infusion Rate)	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%	1 Day Visit (approximately 8 to 11 hours)
Secondary	Maximum Change in GIR (Glucose Infusion Rate)	Maximum change in GIR from baseline after glucagon injection in the presence and absence of ethanol	1 Day Visit (approximately 8 to 11 hours)