ObesityPhase 4exe01NCT03002675
Exenatide and Brown Adipose Tissue
A Phase 4 study testing Bydureon in people with Obesity, run by Ingrid Jazet at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Bydureon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2016to Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Dutch South Asian or white Caucasian male, 20-30 years
- BMI ≥ 18 and ≤ 25 kg/m2
- Good general health
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Ingrid Jazet Jazet, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Ingrid Jazet, MD, PhD, +33-715268161, i.m.jazet@lumc.nl
Mariëtte Boon, PhD, +31-715265462, m.r.boon@lumc.nl
About this study
Official title: The Effect of Exenatide on Brown Adipose Tissue Activity and Energy Expenditure in Healthy Young Men
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.
Read more
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Bydureon
- Keywords
- Adipose tissue, Type 2 diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BydureonDrug
Also called exenatide
exenatide (Bydureon) 2mg s.c. 1x/wk
| Study group | Role | What they receive |
|---|---|---|
| exenatide | Experimental | Participants will receive exenatide (Bydureon, 2mg s.c. 1x/wk, AstraZeneca) during 12 weeks Receives: Drug: Bydureon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of exenatide on BAT activity and energy expenditure in healthy young South Asian compared to white Caucasian men
Measured: End of the study, up to 21 months
Secondary outcomes (1)
Visualisation of BAT as measured with MRI scan compared to FDG-PET CT
Measured: End of the study, up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ingrid Jazet
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Ingrid Jazet, Leiden University Medical Center
- Investigators
- Ingrid Jazet, MD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002675
- Sponsor's protocol ID
- P16.078
- Acronym
- exe01
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Janssen LGM, Nahon KJ, Bracke KFM, van den Broek D, Smit R, Sardjoe Mishre ASD, Koorneef LL, Martinez-Tellez B, Burakiewicz J, Kan HE, van Velden FHP, Pereira Arias-Bouda LM, de Geus-Oei LF, Berbee JFP, Jazet IM, Boon MR, Rensen PCN. Twelve weeks of exenatide treatment increases [18F]fluorodeoxyglucose uptake by brown adipose tissue without affecting oxidative resting energy expenditure in nondiabetic males. Metabolism. 2020 May;106:154167. doi: 10.1016/j.metabol.2020.154167. Epub 2020 Jan 23.
PubMed 31982480
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exenatide on Brown Adipose Tissue Activity and Energy Expenditure in Healthy Young Men
- ClinicalTrials.gov ID
- NCT03002675
- Acronym / sponsor ID
- exe01 / P16.078
- Conditions
- Obesity
- Keywords
- Adipose tissue, Type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ingrid JazetUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2016
- Primary completion
- Jun 2018 (estimated)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exenatide | Experimental | Drug: BydureonParticipants will receive exenatide (Bydureon, 2mg s.c. 1x/wk, AstraZeneca) during 12 weeks |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Dutch South Asian or white Caucasian male, 20-30 years
- BMI ≥ 18 and ≤ 25 kg/m2
- Good general health
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BydureonAlso: exenatideexenatide (Bydureon) 2mg s.c. 1x/wk | Drug | exenatide |
Primary outcome
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
1 secondary outcome
Visualisation of BAT as measured with MRI scan compared to FDG-PET CT
Time frame: End of the study, up to 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2016.
- Derived from this study: PubMed 31982480Janssen LGM, Nahon KJ, Bracke KFM, van den Broek D, Smit R, Sardjoe Mishre ASD, Koorneef LL, Martinez-Tellez B, Burakiewicz J, Kan HE, van Velden FHP, Pereira Arias-Bouda LM, de Geus-Oei LF, Berbee JFP, Jazet IM, Boon MR, Rensen PCN. Twelve weeks of exenatide treatment increases [18F]fluorodeoxyglucose uptake by brown adipose tissue without affecting oxidative resting energy expenditure in nondiabetic males. Metabolism. 2020 May;106:154167. doi: 10.1016/j.metabol.2020.154167. Epub 2020 Jan 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Jazet Jazet, MD contact
Ingrid Jazet, MD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bydureon in people with Obesity, run by Ingrid Jazet at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingrid Jazet Jazet, MD (i.m.jazet@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2016.