Regulation of Intestinal and Hepatic Lipoprotein Particle Production by Blood Glucose in Humans

Healthy Clinical Trial

Official title:

Regulation of Intestinal and Hepatic Lipoprotein Particle Production by Blood Glucose in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607839
• Other study ID #: 12-5569-B
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2015
• Last updated: November 17, 2015
• Start date: February 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of study is to examine whether raised blood glucose enhances lipid particle production independent of effects on gastric emptying and pancreatic/ gastrointestinal hormone production.

Description:

This study will be performed on healthy, lean, non-diabetic males and females who will participate two studies each in random order, 4 to 6 weeks apart. Study A: lipoprotein turnover with intravenous infusion of normal saline. Study B: lipoprotein turnover i.v infusion of glucose. In both studies, subjects will drink a liquid formula every hour to remain in a constant fed state and will be under conditions of pancreatic clamp (with the infusion of hormones somatostatin, insulin, glucagon, growth hormone). Subjects will be blinded with regard to the treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 subject with active bleeding, bleeding diathesis, clotting abnormalities or recent surgery (within past 1 month)

3. 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).

4. History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.

5. 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.

6. Any laboratory values: AST > 2x ULN; ALT > 2x ULN TSH > 6 mU/l

7. Current addiction to alcohol or substances of abuse as determined by the investigator.

8. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation

9. Taking any prescription or non-prescription medications at the time of the study

10. Having donated blood three months prior to and three months post study procedures

11. 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.

12. Known allergy, hypersensitivity or contraindication to receiving study medications.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• glucose or normal saline
20% glucose solution or normal saline, intravenous infusion

Locations

Country	Name	City	State
Canada	Tornto General Hospital, UHN	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Production of TRL-apoB48 between treatments		10 hours	No
Secondary	Production of TRL-apoB100 between treatments		10 hours	No