Status:
COMPLETED
Determining the Responsiveness of Intestinal Lipoprotein Production to an Elevation of Plasma Free Fatty Acids
Lead Sponsor:
University Health Network, Toronto
Conditions:
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Lipoproteins are large complexes of molecules that transport lipids (primarily triglycerides and cholesterol) through the blood. The intestine has traditionally been viewed as a 'passive' organ with r...
Detailed Description
This study proposes to use a published stable isotope method to study the kinetics of apoB48 and apoB100 in the constant fed state in healthy subjects. These studies will be performed in 10 healthy, l...
Eligibility Criteria
Inclusion
- Non-diabetic men and women aged 18-65 years old
- Written informed consent obtained
- Body mass index (BMI) \< 27 kg/m2
- Fasting triglycerides \< 2.5 mmol/l
- Waist circumference \< 90 cm
- Fasting blood glucose \< 6 mmol/l
- Haemoglobin above 130 g/L.
Exclusion
- Patient has a history of hepatitis/hepatic disease that has been active within the previous 2 years.
- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (creatinine \[Cr\] \> 1.5 mg/dL) genitourinary, or hematological systems; or severe uncontrolled treated or untreated hypertension (sitting diastolic blood pressure \[BP\] \> 100 or systolic \> 180); or proliferative retinopathy.
- Fasting blood glucose \> 6 mmol/l or known diabetes.
- Any history of a myocardial infarction (MI) or clinically significant, active, cardiovascular history including a history of arrhythmias or conduction delays on electrocardiogram (ECG), unstable angina, or decompensated heart failure.
- Any laboratory values: AST \> 2x upper limit of normal (ULN); ALT \> 2x ULN; thyroid-stimulating hormone (TSH) \> 6 mU/l.
- Known or suspected allergy to the medication or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions.
- Current addiction to alcohol or substances of abuse as determined by the investigator.
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
- Any lipid lowering or hypoglycemic agents
- Will not donate blood three months before start or three months after completing study.
- Thrombocytopenia
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00152945
Start Date
April 1 2005
End Date
October 1 2008
Last Update
October 2 2012
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2c4