Phase 4
N=15
Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02516150 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: AOCGIR (Area Over the Curve for Glucose Infusion Rate) — 1996; 1981 mg*minute/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ethanol (Drug); Glucagon (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AOCGIR (Area Over the Curve for Glucose Infusion Rate) |
1996; 1981 | — |
| SECONDARY Maximum Change in GIR (Glucose Infusion Rate) From Baseline |
83.0; 101.7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02516150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.