Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose

NCT01694446 | Completed

• 1 other identifier: Glucose 090428B
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Increased postprandial plasma triglycerides are associated with increased cardiovascular risk. Chronic consumption of carbohydrates is associated with increased levels of triglycerides. Very few studies have assessed the effect of acute consumption of carbohydrates on plasma triglycerides and lipoprotein production and clearance. The present study aims to assess the effects of acute administration of glucose and fructose on hepatic and intestinal lipoprotein production.

Conditions

Hyperlipidemia

Keywords

Intestinal lipoprotein; Apo B48 and apoB100; Pancreatic clamp

Outcome Measures

Primary Outcomes (1)

• Assessment of intestinal and hepatic lipoprotein production

  10 hours

Study Arms (1)

Intraduodenal glucose or fructose

EXPERIMENTAL

Other: Intraduodenal glucose or fructose

Interventions

Intraduodenal glucose or fructose OTHER

Intraduodenal glucose or fructose

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 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
• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hopital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Fructose

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

CA (1)