Obesity Clinical Trial
— exe01Official title:
The Effect of Exenatide on Brown Adipose Tissue Activity and Energy Expenditure in Healthy Young Men
NCT number | NCT03002675 |
Other study ID # | P16.078 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | December 15, 2016 |
Last updated | December 21, 2016 |
Start date | August 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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 30 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Ingrid Jazet | AstraZeneca |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of exenatide on BAT activity and energy expenditure in healthy young South Asian compared to white Caucasian men | End of the study, up to 21 months | No | |
Secondary | Visualisation of BAT as measured with MRI scan compared to FDG-PET CT | End of the study, up to 21 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |