Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon like peptide 1) reduces intestinal production of lipoprotein particles. The investigators therefore hypothesise that the drug sitagliptin which prevents the breakdown of GLP-1 will reduce intestinal lipoprotein production in humans. The investigators are unable to speculate whether sitagliptin will affect hepatic lipoprotein production because of lack of of data from animal studies or in vitro data. Sitagliptin is already an approved treatment for type 2 diabetes.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Merck Frosst Canada Ltd.
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

1. Men and women, aged 18 to 60 years

2. Body mass index 20 kg/m2 to 27 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.