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

NCT ID: NCT02607839

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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normal saline

normal saline intravenous infusion

Group Type PLACEBO_COMPARATOR

glucose or normal saline

Intervention Type BIOLOGICAL

20% glucose solution or normal saline, intravenous infusion

glucose

glucose intravenous infusion

Group Type ACTIVE_COMPARATOR

glucose or normal saline

Intervention Type BIOLOGICAL

20% glucose solution or normal saline, intravenous infusion

Interventions

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glucose or normal saline

20% glucose solution or normal saline, intravenous infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Gary Lewis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tornto General Hospital, UHN

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Xiao C, Dash S, Morgantini C, Lewis GF. Intravenous Glucose Acutely Stimulates Intestinal Lipoprotein Secretion in Healthy Humans. Arterioscler Thromb Vasc Biol. 2016 Jul;36(7):1457-63. doi: 10.1161/ATVBAHA.115.307044. Epub 2016 May 5.

Reference Type DERIVED
PMID: 27150393 (View on PubMed)

Other Identifiers

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12-5569-B

Identifier Type: -

Identifier Source: org_study_id