Status:
COMPLETED
Evaluation of CYP450 Activities in Diabetic Patients vs. Non-diabetic Subjects
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive characterization of the ...
Detailed Description
Patients with type 2 diabetes (T2D) require various therapeutic approaches (diet, exercise and drugs) to ensure glycaemic control while minimizing the risk of hypoglycaemia. T2D is also associated wit...
Eligibility Criteria
Inclusion
- Participants will be ≥18 years old
- Body weight index ≤35,
- Non-smokers (\>3 months)
- Patients with type 2 diabetes and good glycemic control (A1C\<7) or poor glycemic control (A1C\>7.0) and healthy non-diabetic subjects will be eligible.
Exclusion
- Subjects with estimated glomerular filtration (MDRD) \<50mL/min/1.73m2
- ALT and AST 3 times above the upper limit of normal
- Organ transplant recipient, inflammatory illnesses (i.e., polyarthritis, severe cirrhosis, infectious diseases, heart failure, HIV, hepatitis)
- Previous history of or an active cancer (except non-melanoma skin cancer)
- Uncontrolled thyroid functions
- Pregnant
- History of drug or alcohol abuse
- Subjects with a history of or current inflammatory bowel diseases including ulcerous colitis and Crohn's disease, and bariatric surgery
- Drugs known to modulate CYP450 activities, subject taking one of the following therapies will be excluded: antibiotics, antivirals, anticancers, CYP450 inducers (carbamazepine, phenobarbital, phenytoin, rifampin, St-John's wort), CYP450 inhibitors (amiodarone, fluvoxamine, fluoxetine, verapamil), immunosuppressors, warfarin, INFs, antibodies or grapefruit juice (\<2-4 weeks) , CYP450 drugs with strong affinity for the selected isoform and with a long half-life, CYP450 mechanism-based inhibitors or an investigational drug
- Intolerance or hypersensitivity to probe drugs in the CRCHUM-MT cocktail or chlorzoxazone/acetaminophen
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT02291666
Start Date
April 1 2015
End Date
July 1 2019
Last Update
July 23 2019
Active Locations (1)
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1
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X0A9