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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
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ingrid Jazet, Leiden University Medical Center

Tracking Information
First Submitted Date  ICMJE December 15, 2016
First Posted Date  ICMJE December 26, 2016
Last Update Posted Date December 26, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
Visualisation of BAT as measured with MRI scan compared to FDG-PET CT [ Time Frame: End of the study, up to 21 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exenatide and Brown Adipose Tissue
Official Title  ICMJE The Effect of Exenatide on Brown Adipose Tissue Activity and Energy Expenditure in Healthy Young Men
Brief Summary

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.

Detailed Description The current study is an open-label single arm prospective design, including 24 healthy young lean males (BMI between 18 and 25 kg/m2), of whom 12 Dutch South Asians and 12 Dutch Caucasians. After a medical screening, included subjects will receive 12 weeks of treatment with the GLP-1 analogue exenatide (Bydureon; 2 mg s.c. 1x/wk). Study subjects will visit the LUMC weekly. Before and after treatment there will be a study day, in which BAT (by means of 18F-FDG PET-CT scan and MRI scan), resting energy expenditure (measured by indirect calorimetry) and fat mass (by bio-impedance analysis) will be measured. Moreover, blood will be drawn to investigate the effects of exenatide on lipid- and glucose metabolism.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Drug: Bydureon
exenatide (Bydureon) 2mg s.c. 1x/wk
Other Name: exenatide
Study Arms  ICMJE Experimental: exenatide
Participants will receive exenatide (Bydureon, 2mg s.c. 1x/wk, AstraZeneca) during 12 weeks
Intervention: Drug: Bydureon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 21, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Dutch South Asian or white Caucasian male, 20-30 years
  • BMI ≥ 18 and ≤ 25 kg/m2
  • Good general health

Exclusion Criteria:

  • BMI > 25 kg/m2 or < 18 kg/m2
  • Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g. beta blockers)
  • Any significant chronic disease
  • Renal, hepatic or endocrine disease
  • Smoking
  • Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
  • Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
  • Contraindications for undergoing an MRI scan:
  • Presence of non-MR safe metal implants or objects in the body.
  • Pacemaker, neurostimulator, hydrocephalus pump, drug pump, non-removable hearing aid, large recent tattoos.
  • Claustrophobia
  • Tinnitus or hyperacusis
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03002675
Other Study ID Numbers  ICMJE P16.078
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ingrid Jazet, Leiden University Medical Center
Study Sponsor  ICMJE Ingrid Jazet
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Ingrid Jazet, MD Leiden University Medical Center
PRS Account Leiden University Medical Center
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP