Metabolically Healthy ObesityNCT05232695
Brown Fat Tissue Related Hormone Levels in Metabolically Healthy and Unhealthy Obese Individuals
An observational study of Metabolically Healthy Obesity, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
There are two types of adipose tissue in humans, white and brown adipose tissue. While the main task of white adipose tissue is energy storage, the main task of brown adipose tissue is energy expenditure. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolically Healthy Obesity
- What is being tested?
- metabolically healthy obese
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Feb 2023
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: individuals who attend to the hospital's obesity outpatient clinics.
Who may be able to join
- Body mass index ≥30
- Body fat percentage ≥30% in women, ≥25% in men
Who cannot join
- antidiabetic medication usage
- antihypetrensive mediaction usage
- lipid lowering medication usage
- pregancy
- hypo/hyperthyroidism
- steroid usage
Show all 9Show fewer
- benign/ malign tumor diagnosis
- liver disease
- secondary causes of obesity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcın City Hospital
Istanbul
About this study
Official title: Comparison of Brown Fat Tissue-related Hormone Levels in Metabolically Healthy and Unhealthy Obese Individuals
There are two types of adipose tissue in humans, white and brown adipose tissue. While the main task of white adipose tissue is energy storage, the main task of brown adipose tissue is energy expenditure. It was previously thought that only infants have brown adipose tissue, however today it is known that metabolically active brown adipose tissue exists in adult humans as well. Brown adipose tissue contributes to metabolic health through both energy expenditure and the cytokines they secrete.
Although obesity is frequently associated with many metabolic dysfunctions and cardiometabolic diseases such as insulin resistance, prediabetes, atherogenic dyslipidemia, metabolic syndrome, some obese individuals have been defined as metabolically healthy obese. The mechanisms underlying the formation of the metabolic healthy obese phenotype are not well understood. In experimental animal studies, it has been suggested that the molecular phenotype of adipose tissue is an important factor affecting metabolic health in obese individuals. One of the most important factors affecting the molecular phenotype of adipose tissue is the browning potential of adipose tissue. Based on this hypothesis, in this study it is aimed to investigate whether the browning of white adipose tissue has an effect on determining the metabolic phenotype of metabolically healthy and unhealthy obese individuals with the same amount of adipose tissue.
Read more
It is known that irisin, FGF21 and NRG4 are hormones that have the ability to brown the white adipose tissue. In our study, it was aimed to investigate whether there is a difference in serum FGF21, irisin and Neuregulin4 (NRG4) levels, which have brown adipose tissue browning potential, in metabolically healthy and unhealthy obese. In this way, it will be found out whether serum FGF21, irisin and NRG4 hormones, which have a browning effect on white adipose tissue, have an effect on the metabolic health of obese individuals and whether these hormones can be a treatment target.
In this project, participants who have BMI ≥30 kg/m2 and no criteria other than metabolic syndrome criteria, except increased waist circumference (blood pressure ≥130/85 mmHg, fasting blood glucose ≥100 mg/dl, triglyceride ≥150 mg/dl, HDL <40mg/dl in men, <50 mg/dl in women) and those without prediabetes will be defined as metabolically healthy obese, on the other hand other obese individuals will be defined as metabolic unhealthy. 10 ml blood samples will be taken from at least 60 metabolically healthy and 60 metabolically unhealthy participants. Serum FGF21, irisin and NRG4 levels will be measured and their levels in metabolically healthy and unhealthy obese individuals will be compared.
- Conditions
- Metabolically Healthy Obesity
- Being tested
- metabolically healthy obese
- Keywords
- metabolically healthy obese, irisin, FGF21, NRG4
- Medical subject headings
- Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolically healthy obeseDiagnostic test
Also called metabolically unhealthy obese
Obese individuals will be divided into 2 groups as metabolic healthy and unhealthy obese, and their batokine concentrations will be compared.
| Study group | Role | What they receive |
|---|---|---|
| metabolically healthy obese individuals | Individuals who have a body mass index equal or higher than 30 kg/m2, no medication usage, who have only high waist circumference without any other metabolic syndrome criteria. Receives: Diagnostic Test: metabolically healthy obese | |
| metabolically unhealthy obese individuals | Individuals who have a body mass index equal or higher than 30 kg/m2, no medication usage, who have more than one metabolic syndrome criteria (as defined below) including high waist circumference. Receives: Diagnostic Test: metabolically healthy obese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific batokine concentrations in metabolically healthy end unhealthy obese individuals.
The participants' irisin, FGF-21 and NRG-4 levels will be measured to compare their concentrations in metabolically healthy and unhealthy obese individuals.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Apr 2021
- Primary completion1 Dec 2022
- Study completion1 Feb 2023
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 Metabolically Healthy 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Hicran Mutlu, Istanbul Medeniyet University
- Investigators
- Hicran Mutlu, Assoc. Prof., Principal investigator, Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcın City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232695
- Sponsor's protocol ID
- Batokines-09
- Status last verified
- May 2023
- First submitted
- 13 Jan 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Publications
White JD, Dewal RS, Stanford KI. The beneficial effects of brown adipose tissue transplantation. Mol Aspects Med. 2019 Aug;68:74-81. doi: 10.1016/j.mam.2019.06.004. Epub 2019 Jun 21.
PubMed 31228478
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Brown Fat Tissue-related Hormone Levels in Metabolically Healthy and Unhealthy Obese Individuals
- ClinicalTrials.gov ID
- NCT05232695
- Acronym / sponsor ID
- Batokines-09
- Conditions
- Metabolically Healthy Obesity
- Keywords
- metabolically healthy obese, irisin, FGF21, NRG4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- 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.
There are two types of adipose tissue in humans, white and brown adipose tissue. While the main task of white adipose tissue is energy storage, the main task of brown adipose tissue is energy expenditure. It was previously thought that only infants have brown adipose tissue, however today it is known that metabolically active brown adipose tissue exists in adult humans as well. Brown adipose tissue contributes to metabolic health through both energy expenditure and the cytokines they secrete.
Although obesity is frequently associated with many metabolic dysfunctions and cardiometabolic diseases such as insulin resistance, prediabetes, atherogenic dyslipidemia, metabolic syndrome, some obese individuals have been defined as metabolically healthy obese. The mechanisms underlying the formation of the metabolic healthy obese phenotype are not well understood. In experimental animal studies, it has been suggested that the molecular phenotype of adipose tissue is an important factor affecting metabolic health in obese individuals. One of the most important factors affecting the molecular phenotype of adipose tissue is the browning potential of adipose tissue. Based on this hypothesis, in this study it is aimed to investigate whether the browning of white adipose tissue has an effect on determining the metabolic phenotype of metabolically healthy and unhealthy obese individuals with the same amount of adipose tissue.
It is known that irisin, FGF21 and NRG4 are hormones that have the ability to brown the white adipose tissue. In our study, it was aimed to investigate whether there is a difference in serum FGF21, irisin and Neuregulin4 (NRG4) levels, which have brown adipose tissue browning potential, in metabolically healthy and unhealthy obese. In this way, it will be found out whether serum FGF21, irisin and NRG4 hormones, which have a browning effect on white adipose tissue, have an effect on the metabolic health of obese individuals and whether these hormones can be a treatment target.
In this project, participants who have BMI ≥30 kg/m2 and no criteria other than metabolic syndrome criteria, except increased waist circumference (blood pressure ≥130/85 mmHg, fasting blood glucose ≥100 mg/dl, triglyceride ≥150 mg/dl, HDL <40mg/dl in men, <50 mg/dl in women) and those without prediabetes will be defined as metabolically healthy obese, on the other hand other obese individuals will be defined as metabolic unhealthy. 10 ml blood samples will be taken from at least 60 metabolically healthy and 60 metabolically unhealthy participants. Serum FGF21, irisin and NRG4 levels will be measured and their levels in metabolically healthy and unhealthy obese individuals will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metabolically healthy obese individuals | – | Diagnostic Test: metabolically healthy obeseIndividuals who have a body mass index equal or higher than 30 kg/m2, no medication usage, who have only high waist circumference without any other metabolic syndrome criteria. |
| metabolically unhealthy obese individuals | – | Diagnostic Test: metabolically healthy obeseIndividuals who have a body mass index equal or higher than 30 kg/m2, no medication usage, who have more than one metabolic syndrome criteria (as defined below) including high waist circumference. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- individuals who attend to the hospital's obesity outpatient clinics.
Key inclusion criteria (2 listed)
- Body mass index ≥30
- Body fat percentage ≥30% in women, ≥25% in men
Key exclusion criteria (9 listed)
- antidiabetic medication usage
- antihypetrensive mediaction usage
- lipid lowering medication usage
- pregancy
- hypo/hyperthyroidism
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 |
|---|---|---|
| metabolically healthy obeseAlso: metabolically unhealthy obeseObese individuals will be divided into 2 groups as metabolic healthy and unhealthy obese, and their batokine concentrations will be compared. | Diagnostic test | metabolically healthy obese individuals, metabolically unhealthy obese individuals |
Primary outcome
Specific batokine concentrations in metabolically healthy end unhealthy obese individuals.
Time frame: 1 year
The participants' irisin, FGF-21 and NRG-4 levels will be measured to compare their concentrations in metabolically healthy and unhealthy obese individuals.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 31228478White JD, Dewal RS, Stanford KI. The beneficial effects of brown adipose tissue transplantation. Mol Aspects Med. 2019 Aug;68:74-81. doi: 10.1016/j.mam.2019.06.004. Epub 2019 Jun 21.
- Individual participant dataSharing planned: Undecided. not yet decided
Related trials for Metabolically Healthy Obesity
Not yet recruiting
Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise
Obesity (BMI>30), Metabolically Healthy Obesity
Recruiting
Small Extracellular Vesicles and Insulin Action
Obesity, Insulin Resistance
Recruiting
Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in Adults With a Metabolically Challenging Profile
Aging, Adults With Overweight and Obesity
Recruiting
Gut, Immune, and Vascular Health in Metabolically Healthy Obesity
Metabolically Healthy Obesity
RecruitingObservational study
Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity
Metabolic Syndrome, Obesity & Overweight
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.
Hicran Mutlu, Assoc. Prof. principal investigator
Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcın City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolically Healthy Obesity, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 19 May 2023. 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific batokine concentrations in metabolically healthy end unhealthy obese individuals. (time frame: 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 NCT05232695, 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 19 May 2023.