Acute Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon

Short name Glucagon

NCTNCT01155206Other id07-0394-A

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 9 participants (actual)
Sponsor: University Health Network, Toronto · Other
Design: Randomized · Single masking
Countries: 1 country
Canada
Start: Jun 2009
Primary completion: Jan 2010
Completion: Jan 2010
First posted: 1 Jul 2010 (estimated)
Last update posted: 2 Dec 2015 (estimated)
Conditions: Diabetes

Timeline

1 trial · 1 completed

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

200920102011

Ph 4
Glucagon
NCT01155206
Jun 2009 to Jan 2010

Registry summary

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

Insulin resistant states are characterized by hepatic lipoprotein (VLDL) particle overproduction. Numerous hormonal and nutritional factors are known to influence hepatic lipoprotein particle production, including insulin and free fatty acids (FFA). In contrast to the liver, the intestine has traditionally been viewed as a 'passive' organ with respect to lipoprotein production, with intestinal lipoprotein particle production determined mainly by the amount of fat ingested and absorbed. Glucagon plays a key role in the regulation of carbohydrate and fatty acid metabolism and has recently been shown for the first time to regulate hepatic lipoprotein production in mice. Ours will be the first study to investigate the effect of glucagon on hepatic and intestinal lipoprotein production in humans.

Interventions

glucagonDrug

Arms2

Experimental
high glucagon
For one of the two studies to be performed in random order, the subject will receive an infusion of glucagon at a dose that has been shown to achieve high physiological plasma levels. The IV glucagon will be administered at a rate of 3ng/kg/min.
Experimental
low glucagon
For one of the two studies to be performed in random order, the subject will receive an infusion of glucagon at a low rate that is designed to mimic basal plasma glucagon concentration. The IV glucagon will be administered at a rate of 0.65ng/kg/min.

Primary outcomes1

Outcomes the sponsor listed as primary.

Triglyceride-rich lipoprotein production rate
Time frame · 0-10 hours

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Men and women, aged 18 to 40 years 2. Body mass index 20 kg/m2 to 25 kg/m2 3. Hemoglobin above 130g/L. 4. Normal glucose tolerance in response to a 75g, 2-hr OGTT Exclusion Criteria: 1. Subject has a history of hepatitis/hepatic disease that has been active within the previous two years. 2. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP \> 100 or systolic \> 180) or proliferative retinopathy 3. Fasting blood glucose \> 6.0 mmol/l or known diabetes. 4. Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure. 5. Any laboratory values: AST \> 2x ULN; ALT \> 2x ULN TSH \> 6 mU/l 6. Current addiction to alcohol or substances of abuse as determined by the investigator. 7. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 8. Taking any prescription or non-prescription medications at the time of the study 9. Having donated blood three months prior to and three months post study procedures 10. A pregnancy test will be performed 1 to 3 days prior to each study in all female subjects. Those who test positive for pregnancy will be excluded.

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