Exenatide (Byetta ®) Regulation of Intestinal and Hepatic Lipoprotein Particle Production in Humans

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Exenatide acutely inhibits intestinal lipoprotein particle production. We are unable to speculate whether exenatide affects hepatic lipoprotein production in humans since there is currently no evidence from animal models or in vitro studies that have demonstrated an effect

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide

Criteria

Inclusion Criteria:

1. Men and women, aged 18 to 60 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. History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.

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.

11. No clinical evidence of neoplasms which have been known to overexpress GLP-1 receptors i.e. pheochromocytomas, brain tumors and embryonic tumors.

12. Hypersensitivity to egg-, soya-,or peanut protein or previous allergy to intralipid

13. Those with known sensitivity to metoclopramide