Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT02516150
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT02516150
Study Brief:
Protocol Section:
NCT02516150