ObesityPhase 4MirabNCT03012113
Mirabegron and Brown Adipose Tissue
A Phase 4 study testing Mirabegron and Short term mild cooling in people with Obesity, run by Ingrid Jazet at 1 site in Netherlands.
Trial summary
Obesity and type 2 diabetes (T2D) are emerging problems worldwide. In particular South Asian individuals (representing 20% of the world population) have an increased risk of obesity and related disorders. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Mirabegron and Short term mild cooling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2016to Sep 2017
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers. 10 white Caucasians, born in the Netherlands. 10 South Asians, living in the Netherlands.
- Age: 18-30 years
- BMI ≤ 25 kg/m2
Who cannot join
- BMI > 25 kg/m2
- Recent excessive weight loss or exercise
- Alcohol and/ or drugs abuse
- Smoking
- Any significant chronic disease, including diabetes
- Renal, hepatic or endocrine disease
Show all 19Show fewer
- Heart disease or arrhythmias
- Thyroid disease or thyroid medication
- Hypertension
- Use of medication known to influence glucose and/or lipid metabolism or BAT activity (e.g. beta blockers or calcium channel blockers)
- Use of drugs that influence cardiac function or affect QT time
- Use of MAO inhibitor
- Use of systemic corticosteroids in previous six weeks
- 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.
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 Mirabegron on Brown Adipose Tissue in Healthy Young White Caucasian and South Asian Men
Obesity and type 2 diabetes (T2D) are emerging problems worldwide. In particular South Asian individuals (representing 20% of the world population) have an increased risk of obesity and related disorders. They are at higher risk for the development of T2D as compared to white Caucasians and develop T2D at a younger age and with lower BMI. The underlying mechanisms that might explain these ethnical differences have not been clarified or understood yet. As a consequence, treatment options are limited and unfocussed, and novel specific strategies are needed.
Brown adipose tissue (BAT) has recently been discovered as a major player in energy metabolism in humans. In a process known as thermogenesis, BAT takes up fatty acids (FA) and glucose from the circulation and subsequently combusts FA and glucose into heat, thereby increasing energy expenditure and improving glucose and FA metabolism. Using 18F-fluorodeoxyglucose (18F-FDG) (positron emission tomography/computed tomography) PET-CT scan analysis investigators have recently shown that South Asian individuals have less brown adipose tissue (BAT) than white Caucasians. This might suggest that they have a lower energy metabolism, which could underlie their increased predisposition for obesity and the development of T2D.
Read more
Activation of BAT, for example by cold exposure, was shown to have beneficial metabolic effects in humans. Cold acclimatization can increase BAT volume, nonshivering thermogenesis, glucose uptake by BAT, as well as decrease fat mass in healthy young men. Therefore activation of BAT is considered as a novel therapeutic target in the treatment of obesity and T2D. As cold exposure is not the most desired therapeutic strategy for humans, current pre-clinical research focuses on pharmacological activation of BAT.
β3-receptor agonists can be used to mimic sympathetic innervation of BAT. Our recent studies using mice with a human-like lipoprotein profile showed that treatment with a β3-receptor agonist decreased fat mass, improved dyslipidemia, increased insulin sensitivity and even attenuated the development of atherosclerosis. Likewise, the novel β3-receptor agonist (Mirabegron) has recently been shown to activate BAT in healthy young men as effectively as cold exposure. Therefore, ß3-receptor agonism would be a promising treatment option to activate BAT and enhance energy expenditure, especially for South Asians.
Currently the most common way to visualize BAT in humans is by 18F-FDG PET-CT scan. However this method is both expensive and invasive, as it uses ionizing radiation. Recently, MRI, which has no radiation burden, has emerged as a novel method to visualize BAT in humans. Activation of BAT results in combustion of intracellular lipid stores, which eventually leads to a lower triglyceride (TG) content. MRI can measure TG content of tissue, and using MRI technology the activation of BAT can be quantified by the relative reduction in the TG content of BAT. The use of MRI to visualize and quantify BAT activity is a safe, cost-effective and innovative alternative to PET-CT, which has a potential to become a new gold standard in the nearby future.
To investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic phenotype of South Asians, investigators will perform a randomized cross-over study in which 20 healthy young men aged 18-30 years with a lean body type (BMI <25 kg/m2) are included. Dutch South Asian individuals (n=10) and matched Dutch white Caucasian individuals (n=10) will participate in a cross-over study consisting of three different regimes.
This study will investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic phenotype of South Asians. The effects of a β3-receptor agonist on BAT activity in South Asians have never been studied before. Elucidating the effects of this β3-receptor agonist on BAT activity in South Asians might have major clinical implications, as it might result in the discovery of a potential novel treatment strategy to combat obesity and T2D in this especially vulnerable population.
Read the detailed description
In the current study, the effect of one single dose of Mirabegron (200 mg) versus placebo and cold-exposure will be studied in health young (18-30 years) Dutch South Asian (n=10) and Dutch Caucasian (n=10) men.
All study subjects will be screened. If the subject meets all the inclusion criteria, is willing to participate in the study and has signed the informed consent, he will be included. All subjects will be asked not to make any changes in their usual diets and physical activities before the start of the whole study.
At screening a thorough medical history and physical examination will be performed. Subjects will be examined while in the fasting state. Anthropometric measurements will be performed as well as a BIA measurement for determination of body fat percentage and basal blood sample will be taken by means of a venapunction. Basal blood measurements include kidney, liver, thyroid, hemoglobulin, natrium, kalium, ureum and lipid parameters as well as glucose concentrations.
If subjects are eligible to participate they first will complete Study day 1, on which we will measure BAT activity and volume before and after cold exposure. Subject will undergo a baseline oxycon and finapres measurement to determine REE and blood pressure and heart rate (30 min). After this a baseline MRI scan will be made followed by an individualized cooling protocol so that the maximum non-shivering thermogenesis is reached. During the cold exposure, skin temperature will be measured via 'iButtons'. One iButtons will be placed under the armpit as an approximation of the 'core temperature'. When shivering temperature is reached, stable cooling period will start (t=0). After 30 minutes of stable cold exposure (t=30) REE and blood pressure and heart rate will be analyzed a second time using a ventilated hood system and the finapres. Thereafter (t=60) BAT activity and volume will be measured using a second MRI scan. Furthermore, during the cooling procedure a venous blood sample will be obtained every 15 minutes to monitor dynamic changes in plasma lipids. In addition, plasma catecholamine concentrations will be determined. If there is no increased BAT activity upon cold stimulation the subject will be excluded from further participation in the study. If there is detectable BAT activity on Study day 1, subjects will participate in Study days 2 and 3 and will be randomized to receive first Mirabegron or placebo to minimize bias.
On study day 2 first baseline oxycon and finapres measurements will be performed to determine REE and blood pressure and heart rate (30 min). Thereafter, the subject will receive a single dose of 200 mg Mirabegron (four tables of 50 mg) (or placebo) (t=0). Again skin temperature will be measured via 'iButtons'. One iButton will be placed under the armpit as an approximation of the 'core temperature'. After 1, 2 and 3 hours (t=60, t=120 and t=180) REE is analyzed using a ventilated hood system and blood pressure and heart rate are monitored using the finapres. Thereafter, 3.5 hours after the administration of the compound (t=210) BAT activity and volume will be determined using an MRI scan. Furthermore, a venous blood sample will be drawn every 15 minutes to monitor changes in plasma lipids. In addition, plasma catecholamine concentrations will be determined.Study day 3 is exactly the same as study day 2, except this time the subject will receive the other compound (either 200 mg Mirabegron or placebo).
All study days will take place at the Leiden University Medical Centre (LUMC). Between study days 2 and 3 a wash-out period of 13 days will be maintained to make sure that the drug is out of the body during the next exam.
- Conditions
- Obesity
- Being tested
- Mirabegron, Short term mild cooling, Placebo Oral Capsule
- 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.
MirabegronDrug
Also called Betmiga
Short term mild coolingOther
Placebo Oral CapsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Short term mild cooling | Other | Subjects will undergo a short term mild cooling protocol consisting of personalized water cooling method for approximately 2 hours. Receives: Other: Short term mild cooling |
| Mirabegron | Active comparator | Subjects will receive one dosage of 200 mg Mirabegron (Astellas Pharma). Receives: Drug: Mirabegron |
| Placebo | Placebo comparator | Subjects will receive one dosage of Placebo, which is packed and labeled to mach the active compound. Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Mirabegron treatment on BAT activity measured by MRI in South Asians compared with white Caucasians.
Brown adipose tissue activity will be measured by means of MRI
Measured: Up to 1 year
Secondary outcomes (4)
Effect of Mirabegron treatment on REE between South Asian and white Caucasian individuals.
Indirect calorimetry will be performed to asses resting energy expenditure
Measured: Up to 1 year
Mild cold exposure and Mirabegron on plasma lipoprotein profiles
Use NMR to analyse lipoproteins in venous blood samples taken during the cooling protocol
Measured: Up to 1 year
Mirabegron treatment on plasma lipid levels between South Asian and white Caucasian individuals.
Use enzymatic assays to determine lipid levels in plasma
Measured: Up to 1 year
The effect of Mirabegron treatment on sympathetic output in South Asian and white Caucasian individuals.
Measure noradrenalin and adrenaline levels in plasma
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ingrid Jazet
- Sponsor type
- University, hospital or other
- 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
- NCT03012113
- Sponsor's protocol ID
- P16.023
- Acronym
- Mirab
- Status last verified
- Jan 2017
- First submitted
- 15 Dec 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoekx CA, Martinez-Tellez B, Straat ME, Bizino MB, van Eyk HJ, Lamb HJ, Smit JWA, Jazet IM, Nahon KJ, Janssen LGM, Rensen PCN, Boon MR. Circulating FGF21 is lower in South Asians compared with Europids with type 2 diabetes mellitus. Endocr Connect. 2025 Jan 6;14(2):e240362. doi: 10.1530/EC-24-0362. Print 2025 Feb 1.
PubMed 39641307Straat ME, Jurado-Fasoli L, Ying Z, Nahon KJ, Janssen LGM, Boon MR, Grabner GF, Kooijman S, Zimmermann R, Giera M, Rensen PCN, Martinez-Tellez B. Cold exposure induces dynamic changes in circulating triacylglycerol species, which is dependent on intracellular lipolysis: A randomized cross-over trial. EBioMedicine. 2022 Dec;86:104349. doi: 10.1016/j.ebiom.2022.104349. Epub 2022 Nov 11.
PubMed 36371986
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mirabegron on Brown Adipose Tissue in Healthy Young White Caucasian and South Asian Men
- ClinicalTrials.gov ID
- NCT03012113
- Acronym / sponsor ID
- Mirab / P16.023
- Conditions
- Obesity
- Keywords
- Adipose tissue, Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ingrid JazetUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 6 Jan 2017 (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.
Obesity and type 2 diabetes (T2D) are emerging problems worldwide. In particular South Asian individuals (representing 20% of the world population) have an increased risk of obesity and related disorders. They are at higher risk for the development of T2D as compared to white Caucasians and develop T2D at a younger age and with lower BMI. The underlying mechanisms that might explain these ethnical differences have not been clarified or understood yet. As a consequence, treatment options are limited and unfocussed, and novel specific strategies are needed.
Brown adipose tissue (BAT) has recently been discovered as a major player in energy metabolism in humans. In a process known as thermogenesis, BAT takes up fatty acids (FA) and glucose from the circulation and subsequently combusts FA and glucose into heat, thereby increasing energy expenditure and improving glucose and FA metabolism. Using 18F-fluorodeoxyglucose (18F-FDG) (positron emission tomography/computed tomography) PET-CT scan analysis investigators have recently shown that South Asian individuals have less brown adipose tissue (BAT) than white Caucasians. This might suggest that they have a lower energy metabolism, which could underlie their increased predisposition for obesity and the development of T2D.
Activation of BAT, for example by cold exposure, was shown to have beneficial metabolic effects in humans. Cold acclimatization can increase BAT volume, nonshivering thermogenesis, glucose uptake by BAT, as well as decrease fat mass in healthy young men. Therefore activation of BAT is considered as a novel therapeutic target in the treatment of obesity and T2D. As cold exposure is not the most desired therapeutic strategy for humans, current pre-clinical research focuses on pharmacological activation of BAT.
β3-receptor agonists can be used to mimic sympathetic innervation of BAT. Our recent studies using mice with a human-like lipoprotein profile showed that treatment with a β3-receptor agonist decreased fat mass, improved dyslipidemia, increased insulin sensitivity and even attenuated the development of atherosclerosis. Likewise, the novel β3-receptor agonist (Mirabegron) has recently been shown to activate BAT in healthy young men as effectively as cold exposure. Therefore, ß3-receptor agonism would be a promising treatment option to activate BAT and enhance energy expenditure, especially for South Asians.
Currently the most common way to visualize BAT in humans is by 18F-FDG PET-CT scan. However this method is both expensive and invasive, as it uses ionizing radiation. Recently, MRI, which has no radiation burden, has emerged as a novel method to visualize BAT in humans. Activation of BAT results in combustion of intracellular lipid stores, which eventually leads to a lower triglyceride (TG) content. MRI can measure TG content of tissue, and using MRI technology the activation of BAT can be quantified by the relative reduction in the TG content of BAT. The use of MRI to visualize and quantify BAT activity is a safe, cost-effective and innovative alternative to PET-CT, which has a potential to become a new gold standard in the nearby future.
To investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic phenotype of South Asians, investigators will perform a randomized cross-over study in which 20 healthy young men aged 18-30 years with a lean body type (BMI <25 kg/m2) are included. Dutch South Asian individuals (n=10) and matched Dutch white Caucasian individuals (n=10) will participate in a cross-over study consisting of three different regimes.
This study will investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic phenotype of South Asians. The effects of a β3-receptor agonist on BAT activity in South Asians have never been studied before. Elucidating the effects of this β3-receptor agonist on BAT activity in South Asians might have major clinical implications, as it might result in the discovery of a potential novel treatment strategy to combat obesity and T2D in this especially vulnerable population.
Detailed description
In the current study, the effect of one single dose of Mirabegron (200 mg) versus placebo and cold-exposure will be studied in health young (18-30 years) Dutch South Asian (n=10) and Dutch Caucasian (n=10) men.
All study subjects will be screened. If the subject meets all the inclusion criteria, is willing to participate in the study and has signed the informed consent, he will be included. All subjects will be asked not to make any changes in their usual diets and physical activities before the start of the whole study.
At screening a thorough medical history and physical examination will be performed. Subjects will be examined while in the fasting state. Anthropometric measurements will be performed as well as a BIA measurement for determination of body fat percentage and basal blood sample will be taken by means of a venapunction. Basal blood measurements include kidney, liver, thyroid, hemoglobulin, natrium, kalium, ureum and lipid parameters as well as glucose concentrations.
If subjects are eligible to participate they first will complete Study day 1, on which we will measure BAT activity and volume before and after cold exposure. Subject will undergo a baseline oxycon and finapres measurement to determine REE and blood pressure and heart rate (30 min). After this a baseline MRI scan will be made followed by an individualized cooling protocol so that the maximum non-shivering thermogenesis is reached. During the cold exposure, skin temperature will be measured via 'iButtons'. One iButtons will be placed under the armpit as an approximation of the 'core temperature'. When shivering temperature is reached, stable cooling period will start (t=0). After 30 minutes of stable cold exposure (t=30) REE and blood pressure and heart rate will be analyzed a second time using a ventilated hood system and the finapres. Thereafter (t=60) BAT activity and volume will be measured using a second MRI scan. Furthermore, during the cooling procedure a venous blood sample will be obtained every 15 minutes to monitor dynamic changes in plasma lipids. In addition, plasma catecholamine concentrations will be determined. If there is no increased BAT activity upon cold stimulation the subject will be excluded from further participation in the study. If there is detectable BAT activity on Study day 1, subjects will participate in Study days 2 and 3 and will be randomized to receive first Mirabegron or placebo to minimize bias.
On study day 2 first baseline oxycon and finapres measurements will be performed to determine REE and blood pressure and heart rate (30 min). Thereafter, the subject will receive a single dose of 200 mg Mirabegron (four tables of 50 mg) (or placebo) (t=0). Again skin temperature will be measured via 'iButtons'. One iButton will be placed under the armpit as an approximation of the 'core temperature'. After 1, 2 and 3 hours (t=60, t=120 and t=180) REE is analyzed using a ventilated hood system and blood pressure and heart rate are monitored using the finapres. Thereafter, 3.5 hours after the administration of the compound (t=210) BAT activity and volume will be determined using an MRI scan. Furthermore, a venous blood sample will be drawn every 15 minutes to monitor changes in plasma lipids. In addition, plasma catecholamine concentrations will be determined.Study day 3 is exactly the same as study day 2, except this time the subject will receive the other compound (either 200 mg Mirabegron or placebo).
All study days will take place at the Leiden University Medical Centre (LUMC). Between study days 2 and 3 a wash-out period of 13 days will be maintained to make sure that the drug is out of the body during the next exam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short term mild cooling | Other | Other: Short term mild coolingSubjects will undergo a short term mild cooling protocol consisting of personalized water cooling method for approximately 2 hours. |
| Mirabegron | Active comparator | Drug: MirabegronSubjects will receive one dosage of 200 mg Mirabegron (Astellas Pharma). |
| Placebo | Placebo comparator | Drug: Placebo Oral CapsuleSubjects will receive one dosage of Placebo, which is packed and labeled to mach the active compound. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male volunteers. 10 white Caucasians, born in the Netherlands. 10 South Asians, living in the Netherlands.
- Age: 18-30 years
- BMI ≤ 25 kg/m2
Key exclusion criteria (19 listed)
- BMI > 25 kg/m2
- Recent excessive weight loss or exercise
- Alcohol and/ or drugs abuse
- Smoking
- Any significant chronic disease, including diabetes
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 |
|---|---|---|
| MirabegronAlso: Betmiga | Drug | Mirabegron |
| Short term mild cooling | Other | Short term mild cooling |
| Placebo Oral Capsule | Drug | Placebo |
Primary outcome
The effect of Mirabegron treatment on BAT activity measured by MRI in South Asians compared with white Caucasians.
Time frame: Up to 1 year
Brown adipose tissue activity will be measured by means of MRI
4 secondary outcomes
Effect of Mirabegron treatment on REE between South Asian and white Caucasian individuals.
Time frame: Up to 1 year
Mild cold exposure and Mirabegron on plasma lipoprotein profiles
Time frame: Up to 1 year
Mirabegron treatment on plasma lipid levels between South Asian and white Caucasian individuals.
Time frame: Up to 1 year
The effect of Mirabegron treatment on sympathetic output in South Asian and white Caucasian individuals.
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Derived from this study: PubMed 39641307Hoekx CA, Martinez-Tellez B, Straat ME, Bizino MB, van Eyk HJ, Lamb HJ, Smit JWA, Jazet IM, Nahon KJ, Janssen LGM, Rensen PCN, Boon MR. Circulating FGF21 is lower in South Asians compared with Europids with type 2 diabetes mellitus. Endocr Connect. 2025 Jan 6;14(2):e240362. doi: 10.1530/EC-24-0362. Print 2025 Feb 1.
- Derived from this study: PubMed 36371986Straat ME, Jurado-Fasoli L, Ying Z, Nahon KJ, Janssen LGM, Boon MR, Grabner GF, Kooijman S, Zimmermann R, Giera M, Rensen PCN, Martinez-Tellez B. Cold exposure induces dynamic changes in circulating triacylglycerol species, which is dependent on intracellular lipolysis: A randomized cross-over trial. EBioMedicine. 2022 Dec;86:104349. doi: 10.1016/j.ebiom.2022.104349. Epub 2022 Nov 11.
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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, 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 Mirabegron and Short term mild cooling 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 19 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 6 Jan 2017. 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. Some participants in this study may receive a placebo. 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, MD (+31 75262997, 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 Mirabegron treatment on BAT activity measured by MRI in South Asians compared with white Caucasians. (time frame: Up to 1 year). 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 NCT03012113, which also lists 2 linked publications.
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 6 Jan 2017.