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

NCT02516150 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2015P001323
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes; Bionic Pancreas; Artificial Pancreas; Insulin; Glucagon; Alcohol; Alcohol Clamp

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maximum Change in GIR (Glucose Infusion Rate) From Baseline

  1 Day Visit (approximately 8 to 11 hours)

Study Arms (2)

Glucagon with Ethanol

EXPERIMENTAL

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.

Drug: Ethanol; Drug: Glucagon

Glucagon without Ethanol

ACTIVE COMPARATOR

Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.

Drug: Glucagon

Interventions

Ethanol DRUG

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

Also known as: Ethyl Alcohol, Alcohol

Glucagon with Ethanol

Glucagon DRUG

injection of 50 micrograms of glucagon

Glucagon with Ethanol; Glucagon without Ethanol

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Diabetes Research Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Ethanol; Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Courtney Balliro
• Organization: Massachusetts General Hospital

cballiro@partners.org

617-726-1242

Study Officials

• Steven J Russell, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 5, 2015
• Study Start: March 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 31, 2017
• Results First Posted: August 31, 2017

Record last verified: 2017-07

Locations

US (1)