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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Ethanol; Glucagon; Glucagon-Like Peptide 1; Hypoglycemic Agents

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.