Exenatide and Brown Adipose Tissue (exe01)
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|ClinicalTrials.gov Identifier: NCT03002675|
Recruitment Status : Unknown
Verified December 2016 by Ingrid Jazet, Leiden University Medical Center.
Recruitment status was: Recruiting
First Posted : December 26, 2016
Last Update Posted : December 26, 2016
The obesity epidemic has led to a enormous increase in the prevalence of type 2 diabetes mellitus (T2D), dyslipidemia and cardiovascular events. Particularly South Asians, who comprise 1/5 of the world population, are at increased risk of developing a disadvantageous metabolic phenotype and these diseases. Moreover, T2D occurs at a younger age and at a lower BMI when compared to white Caucasians. Recent research has shown that South Asians not only have a lower energy expenditure than their Caucasian counterparts, but also less active brown adipose tissue (BAT).
For some time, it has been known that adult humans have active BAT. This metabolic tissue produces heat by combusting triglycerides, in contrast to white adipose tissue, which stores this form of energy. It has been shown that activation of BAT has a positive effect on whole body metabolism, via increasing energy expenditure and improving glucose- and lipid metabolism. For this matter, BAT has been proposed as a major key player in energy homeostasis, which may be implemented in the current combat against the obesity epidemic. Aside from cold exposure, more research focuses on pharmacological activation of BAT.
Glucagon-like peptide 1 (GLP-1) is an incretin hormone which is produced by intestinal L-cells and upon food intake stimulates insulin secretion by pancreatic beta cells. The GLP-1 analogue Exenatide is a currently much used antidiabetic drug to reduce hyperglycemia via this aforementioned mechanism. Beyond its blood glucose-improving effects, Exenatide has also shown to lower body weight and improve dyslipidemia in T2D patients. Elucidation of the underlying mechanism of these beneficial effects is highly relevant.
Recent preclinical research in our group has shown that central activation of the GLP-1 receptor through exenatide increases BAT activity and thereby contributes to weight loss and improvement of dyslipidemia. The aim of this research project is to investigate whether exenatide is also able to activate BAT and increase resting energy expenditure, thereby improving glucose- and lipid metabolism and reducing fat mass and body weight in humans. Moreover, the investigators aim to validate the MRI scan as a novel way to measure BAT activity. The investigators hope that these forthcoming findings lead to the discovery of new treatment strategies against obesity.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: Bydureon||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Exenatide on Brown Adipose Tissue Activity and Energy Expenditure in Healthy Young Men|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||June 2018|
Participants will receive exenatide (Bydureon, 2mg s.c. 1x/wk, AstraZeneca) during 12 weeks
exenatide (Bydureon) 2mg s.c. 1x/wk
Other Name: exenatide
- The effect of exenatide on BAT activity and energy expenditure in healthy young South Asian compared to white Caucasian men [ Time Frame: End of the study, up to 21 months ]
- Visualisation of BAT as measured with MRI scan compared to FDG-PET CT [ Time Frame: End of the study, up to 21 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002675
|Contact: Ingrid Jazet Jazet, MDfirstname.lastname@example.org|
|Principal Investigator:||Ingrid Jazet, MD||Leiden University Medical Center|