Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose (glucose)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01694446
First received: September 24, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Hyperlipidemia
Other: Intraduodenal glucose or fructose

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Assessment of intestinal and hepatic lipoprotein production [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: September 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraduodenal glucose or fructose Other: Intraduodenal glucose or fructose

Detailed Description:

Each subject will be studied twice 4-6 weeks apart in random order in this single blinded study. A nasoduodenal tube will be sited under fluoroscopic guidance the day prior to the study.In study A they will receive intraduodenal intralipid (20% at 60 ml/hour) alongside 60 ml/hour of 20% dextrose or fructose for 15 hours starting at 4am. In study B they will receive 60 ml/hour of intraduodenal intralipid with 60ml/hour of normal saline for 15 hours from 4am. A pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) along with saline/sitagliptin will be started at 7am. From 9am an iv bolus of deuterated-glycerol (d5-glycerol) along with a regular infusion of deuterated leucine (L-[5,5,5-2H3]. Regular blood samples will be drawn to assess lipoprotein kinetics.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694446

Contacts
Contact: Brenda Hughes, RN 416-340-8886 brenda.hughes@uhn.ca

Locations
Canada, Ontario
Toronto General Hopital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Brenda Hughes, RN    416-340-8886    brenda.hughes@uhn.ca   
Contact: Gary Lewis, MD FRCPC    416-340-4270    gary.lewis@uhn.ca   
Principal Investigator: Gary Lewis, MD FRCPC         
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01694446     History of Changes
Other Study ID Numbers: Glucose 090428B
Study First Received: September 24, 2012
Last Updated: September 26, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Intestinal lipoprotein
Apo B48 and apoB100
Pancreatic clamp

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 31, 2014