Clinical trial NCT02516150: Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon
Official title: Effect of Ethanol Intoxication on the Anti-hypoglycemic Action of Glucagon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes
Bionic Pancreas
Artificial Pancreas
Insulin
Glucagon
Alcohol
Alcohol Clamp
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: AOCGIR (Area Over the Curve for Glucose Infusion Rate)
timeFrame: 1 Day Visit (approximately 8 to 11 hours)
Secondary outcomes:
measure: Maximum Change in GIR (Glucose Infusion Rate) From Baseline
timeFrame: 1 Day Visit (approximately 8 to 11 hours)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Diabetes Research Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven J Russell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: