Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04823442
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2021-03-26
Brief Title:
Activation of Brown Adipose Tissue Metabolism Using Mirabegron
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Sympathomimetics and Sympatholytics in Type 2 Diabetes Teaching Old Drugs New Tricks
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GB9
Brief Summary:
Could sympathomimetics and sympatholytics drugs safe for the management of Type 2 Diabetes T2D Based on recent evidence we propose that pharmacological stimulation of Beta-3 adrenergic receptor ADBR3 at higher doses of Mirabegron may be required to elicit changes in glycemia but should be combined with Beta-1 adrenergic receptor ADRB1 antagonists to suppress the unwanted effects on the cardiovascular system
Together several results establish a previously unappreciated cross-talk between Gs-coupled ADRB1 and ADRB3 in adipose tissue for the control of glucose homeostasis Moreover these data suggest that antagonizing ADRB1 may be a good way to significantly lower the dose of ADRB3 agonist required for glucose control
Therefore we believe that there are therapeutic opportunities in targeting adrenergic receptors for the treatment of T2D at least in youngmiddle aged people
Together several results establish a previously unappreciated cross-talk between Gs-coupled ADRB1 and ADRB3 in adipose tissue for the control of glucose homeostasis Moreover these data suggest that antagonizing ADRB1 may be a good way to significantly lower the dose of ADRB3 agonist required for glucose control
Therefore we believe that there are therapeutic opportunities in targeting adrenergic receptors for the treatment of T2D at least in youngmiddle aged people
Detailed Description:
In brief participants will take part in 2 metabolic studies A and B performed in random order and at an interval of 7 to 14 days Each metabolic study will last 85 hours with a baseline period of 25 hours Participants will ingest either 200 mg of the ADRB3 agonist mirabegron Myrbetriq Astellas Pharma Canada alone study A or in combination with 10 mg of bisoprolol an ADRB1-antagonist study B at time 0
The radioactive PET tracers PET positron emission tomography used in this study are the 11C-acetate and 18F-FDG to estimate BAT oxidative metabolism and glucose metabolism respectively The perfusion of 66 D2-glucose 11233-2H-glycerol and U-13C-palmitate stable isotopes will also be performed in this study from time -150 min to 300 min to examine the systemic appearance rate of glucose glycerol and fatty acids respectively These studies will be almost identical same perfusion of stable and radioactive tracers same number of PET acquisitions except for the drug which will be administered orally at time 0
The radioactive PET tracers PET positron emission tomography used in this study are the 11C-acetate and 18F-FDG to estimate BAT oxidative metabolism and glucose metabolism respectively The perfusion of 66 D2-glucose 11233-2H-glycerol and U-13C-palmitate stable isotopes will also be performed in this study from time -150 min to 300 min to examine the systemic appearance rate of glucose glycerol and fatty acids respectively These studies will be almost identical same perfusion of stable and radioactive tracers same number of PET acquisitions except for the drug which will be administered orally at time 0
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None