Expired Study
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Boston, Massachusetts 02114


Purpose:

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.


Study 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. 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.


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.


NCT ID:

NCT02516150


Primary Contact:

Principal Investigator
Steven J Russell, MD, PhD
Massachusetts General Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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