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

NCT02607839 | Completed Phase 2

• 1 other identifier: 12-5569-B
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

lipid handling by the gut and liver

Outcome Measures

Primary Outcomes (1)

• Production of TRL-apoB48 between treatments

  10 hours

Secondary Outcomes (1)

• Production of TRL-apoB100 between treatments

  10 hours

Study Arms (2)

normal saline

PLACEBO COMPARATOR

normal saline intravenous infusion

Biological: glucose or normal saline

glucose

ACTIVE COMPARATOR

glucose intravenous infusion

Biological: glucose or normal saline

Interventions

glucose or normal saline BIOLOGICAL

20% glucose solution or normal saline, intravenous infusion

glucose; normal saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women, aged 18 to 60 years
• Body mass index 20 kg/m2 to 27 kg/m2
• Hemoglobin above 130g/L
• Normal glucose tolerance in response to a 75g, 2-hr OGTT

You may not qualify if:

• Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
• Any subject with active bleeding, bleeding diathesis, clotting abnormalities or recent surgery (within past 1 month)
• 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).
• History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
• 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.
• Any laboratory values: AST \> 2x ULN; ALT \> 2x ULN TSH \> 6 mU/l
• Current addiction to alcohol or substances of abuse as determined by the investigator.
• Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
• Taking any prescription or non-prescription medications at the time of the study
• Having donated blood three months prior to and three months post study procedures
• 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.
• Known allergy, hypersensitivity or contraindication to receiving study medications.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Tornto General Hospital, UHN

Toronto, Ontario, M5G 1L7, Canada

Location

Related Publications (1)

• 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.

  PMID: 27150393 DERIVED

MeSH Terms

Interventions

Glucose; Saline Solution

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 18, 2015
• Study Start: February 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

CA (1)