Physiologic Response to Glucagon at Varying Insulin Levels

NCTNCT01483651Other idkw02

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 11 participants (actual)
Sponsor: Legacy Health System · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: Nov 2011
Primary completion: Mar 2013
Completion: Mar 2013
First posted: 1 Dec 2011 (estimated)
Last update posted: 29 Mar 2016 (estimated)
Conditions: Type 1 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2011201220132014

N/A
Physiologic Response to Glucagon at Varying Insulin Levels
NCT01483651
Nov 2011 to Mar 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this research study is to test how different levels of insulin block the effect of glucagon. Insulin is a hormone that lowers blood glucose. Glucagon raises blood glucose. Both are natural hormones made by people without diabetes. Sensor-based blood glucose control studies have been done by our research group using glucagon in small doses to prevent hypoglycemia (low blood sugar). However, sometimes glucagon does not work to raise blood sugar. The investigators believe this is because of too much insulin in the body. This study will help determine how different levels of insulin in the body affect the ability of glucagon to raise blood sugar.

Interventions

GlucagonDrug
InsulinDrug

Arms6

Experimental
Low, Medium and High insulin infusion
All study subjects in this arm were randomized as follows: First study is regular insulin infused at lowest level with glucagon administration. Second study is regular insulin infused at medium level with glucagon adminstration. Third study is regular insulin infused at highest level with glucagon administration.
Experimental
Low, High and Medium insulin infusion
All study subjects in this arm were randomized as follows: First study is regular insulin infused at lowest level with glucagon administration. Second study is regular insulin infused at highest level with glucagon adminstration. Third study is regular insulin infused at medium level with glucagon administration.
Experimental
Medium, Low and High insulin infusion
All study subjects in this arm were randomized as follows: First study is regular insulin infused at medium level with glucagon administration. Second study is regular insulin infused at lowest level with glucagon adminstration. Third study is regular insulin infused at highest level with glucagon administration.
Experimental
Medium, High and Low insulin infusion
All study subjects in this arm were randomized as follows: First study is regular insulin infused at medium level with glucagon administration. Second study is regular insulin infused at highest level with glucagon adminstration. Third study is regular insulin infused at lowest level with glucagon administration.
Experimental
High, Low and Medium insulin infusion
All study subjects in this arm were randomized as follows: First study is regular insulin infused at highest level with glucagon administration. Second study is regular insulin infused at lowest level with glucagon adminstration. Third study is regular insulin infused at medium level with glucagon administration.
Experimental
High, Medium and Low insulin infusion
All study subjects in this arm were randomized as follows: First study is regular insulin infused at highest level with glucagon administration. Second study is regular insulin infused at medium level with glucagon adminstration. Third study is regular insulin infused at lowest level with glucagon administration.

Primary outcomes1

Outcomes the sponsor listed as primary.

Area Under the Curve for Glucose Above Baseline
Time frame · 60 minutes after each glucagon administration
Registry description
The change in the rate of glucose appearance will be assessed by measuring the stable glucose isotope (dideuterated glucose, D2) using a gas chromatography-mass spectrometry assay. The units of the area under the curve are defined as milligrams per kilogram of glucose, since the dependent variable is a rate of glucose production \[mg/kg/min\] measured over time \[min\]. The time variable therefore cancels out. Additionally, this area under the curve is being normalized per microgram of glucagon delivered.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 60 minutes after each glucagon administration

Area Under the Curve for Glucose Above Baseline

Group	Value (mg/kg glucose per mcg glucagon)	Spread
Low Insulin Infusion Rate	0.623	0.3
Medium Insulin Infusion Rate	0.59	0.4
High Insulin Infusion Rate	0.03	0.16

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Low Insulin InfusionRegular insulin infused at lowest level with glucagon administration.	–	0 / 10	7 / 10
Medium Insulin InfusionRegular insulin infused at medium level with glucagon administration.	–	0 / 9	8 / 9
High Insulin Infusionregular insulin infused at highest level with glucagon administration.	–	0 / 10	5 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus for at least 1 year * Male or female subjects 21 to 65 years of age * Current use of an insulin pump * Willingness to sign informed consent and HIPAA documents and follow all study procedures Exclusion Criteria: * Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study * Renal insufficiency (serum creatinine of 2.0 mg/dL or greater) * Liver abnormalities: Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2 * Adrenal insufficiency * Hematocrit of less than or equal to 34% * A history of cerebrovascular disease or coronary artery disease regardless of the time since occurrence * Congestive heart failure, NYHA class III or IV * Cardiac rhythm disturbance characterized by: 2nd or 3rd degree heart block, bradycardia of less than 50 bpm (exception of bradycardia in an aerobic athlete), tachycardia of greater than 100 bpm, or any arrhythmia judged by the investigator to be exclusionary * Any active infection * Active foot ulceration * Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication * Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator) * Active malignancy, except basal cell or squamous cell skin cancers * Major surgical operation within 30 days prior to screening * Seizure disorder * Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen * Chronic usage of any immunosuppressive medication * Current administration of oral or parenteral corticosteroids * Use of an investigational drug within 30 days prior to screening * Bleeding disorder, treatment with warfarin, or platelet count below 50,000 * Allergy to glucagon * Past history of pheochromocytoma or a family history of MEN 2, neurofibromatosis, or von Hippel-Lindau disease * Insulin resistance requiring more than 200 units per day

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