Back to resultsRegulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose (glucose)
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intraduodenal glucose or fructose
Sponsored by
About this trial
This is an interventional basic science trial for Hyperlipidemia focused on measuring Intestinal lipoprotein, Apo B48 and apoB100, Pancreatic clamp
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
-
Sites / Locations
- Toronto General Hopital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraduodenal glucose or fructose
Arm Description
Outcomes
Primary Outcome Measures
Assessment of intestinal and hepatic lipoprotein production
Secondary Outcome Measures
Full Information
NCT ID
NCT01694446
First Posted
September 24, 2012
Last Updated
March 6, 2015
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01694446
Brief Title
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
Acronym
glucose
Official Title
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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, glucagon and growth hormone) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Intestinal lipoprotein, Apo B48 and apoB100, Pancreatic clamp
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraduodenal glucose or fructose
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Intraduodenal glucose or fructose
Primary Outcome Measure Information:
Title
Assessment of intestinal and hepatic lipoprotein production
Time Frame
10 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
-
Facility Information:
Facility Name
Toronto General Hopital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
We'll reach out to this number within 24 hrs