MutationNCT02808715
Identification and Metabolic Characterization of a Cohort of Human Subjects With Mutations in PRDM-16
An observational study of Mutation and Obesity, run by National Heart Centre Singapore.
Trial summary
Chinese male subjects will be invited to participate in a research study of brown fat, a special tissue in the body that is designed to burn energy to make heat. The objective is to learn the importance of a gene called "PRDM-16" for the function of brown fat. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mutation, Obesity, Dyslipidemia
- What is being tested?
- Blood Sample Collection
- How many people
- 247 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jan 2016
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 500 subjects will be recruited from the IMU healthy volunteer database. The investigators will enroll male Chinese volunteers. Women, children and the elderly are excluded from our initial study since prior research suggests that age and sex has an effect on brown fat function. In order to study the role of PRDM-16 in brown fat function the investigators wish to keep other contributing variables static in our study.
Who may be able to join
- Male
- Chinese
- Age >= 21 and =< 50
- BMI >=18.5 and =< 30
- Ability to provide written, informed consent.
- To control for this the investigators will include only adult Chinese men less than 50 years old.
- Since obesity also alters brown fat function the investigators will exclude those with BMI>30.
Who cannot join
- Diagnosis of DM2
- Use of beta blockers, TZD (ie rosiglitazone/pioglitazone) or metformin Since the subjects will be recruited from the IMU healthy volunteer database there should be no prior history of DM2 or medication use. Nevertheless, diagnosis of DM2 and use of the drugs listed can alter brown fat activity and interfere with our analysis.
- Presence of pacemakers or foreign metallic objects in the eyes. Future planned experiments with the identified cohort include cardiac MRI. Subjects with pacemakers or foreign metallic objects in the eyes will be ineligible for this potential follow-up study.
About this study
Chinese male subjects will be invited to participate in a research study of brown fat, a special tissue in the body that is designed to burn energy to make heat. The objective is to learn the importance of a gene called "PRDM-16" for the function of brown fat. Subjects were selected as a possible subject in this study because they fulfil the age and weight criteria.
500 subjects from the Singhealth Investigational Medicine Unit healthy volunteer database will be recruited over a period of 2 years. All of the subjects will have their PRDM-16 gene sequenced. The objective is to identify subjects with mutations, or changes, in their PRDM-16 gene. About 12 subjects with PRDM-16 mutations are expected to be identified.
Samples of blood obtained during the course of this study will be stored and analysed only for the purposes of this study for a period not exceeding 2 years, and will be destroyed after completion of the study, unless subject is agreeable to donate the samples to the National Heart Centre Singapore for continuous storage for future studies that are approved by the institutional review board..
Read the detailed description
The long-term objective of this study is to develop new treatments for obesity and obesity-associated disorders such as diabetes and dyslipidemia. The recent finding of active brown fat depots in adult humans provides an exciting new strategy for the treatment of these diseases. Brown fat is a specialized organ found primarily in small mammals. Brown fat has the unique capability to burn fuel at high rates in order to generate heat. The role of brown fat in mammals is to defend against cold exposure. Human infants have active brown fat deposits located in the intra-scapular region. This brown fat depot regresses with age and it was long thought that adult humans had no brown fat tissue. Recent studies have demonstrated the presence of brown fat activity in adult humans following exposure to cold. Brown fat in adult humans is concentrated in the cervical region and displays some sex-specific differences. Furthermore the size of the depot is inversely correlated with BMI and age of the subjects. This finding has generated intense interest as it opens up the possibility of harnessing brown fat as a means of combating obesity and obesity-related disorders in man. Indeed, maneuvers that activate brown fat in humans have been shown to cause reductions in fat mass.
Much of our understanding of brown fat biology comes from work in mice. Of particular relevance for the treatment of human disease are several findings. First, increasing brown fat activity in mice renders the animals resistant to the development of obesity on a high fat diet. Second, levels of insulin sensitivity are directly related to brown fat activity. Finally, the transcription factor factor PR-domain containing protein 16 (PRDM-16) is crucial for directing the biology of brown fat.
The overall goal of the study is to translate the findings from mouse studies of brown fat into human subjects. This is an important first step in the process of developing brown fat-targeted therapies to treat human metabolic diseases such as obesity and insulin resistance. In view of this the investigators are interested in answering several questions. First, do humans with mutations in PRDM-16 have defects in brown fat activity? Recently, humans with mutations in PRDM-16 were identified and found to have a cardiomyopathy phenotype. The brown fat function in these individuals has not been described. By employing a genetic screen of volunteers the investigators hope to identify subjects in Singapore with defects in PRDM-16. Prior studies in humans suggest that the size of the brown fat depot is inversely correlated with BMI and age of the subjects and that depot size varies between the sexes. In order to eliminate BMI, age and sex as confounding variables the investigators will include male subjects of Chinese race between the ages of 21 and 50 and with BMI greater than 18.5 but less than 30. The investigators will include only Chinese subjects to avoid confounding our initial study with variables that relate to race of the subjects. The identification of human subjects carrying mutations in PRDM-16 will set the stage for further studies that will attempt to several research questions. These include whether humans with PRDM-16 mutations have defects in brown fat and the metabolic consequences for humans with defective brown fat.
- Conditions
- Mutation, Obesity, Dyslipidemia, Diabetes
- Being tested
- Blood Sample Collection
- Medical subject headings
- Obesity, Dyslipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
Blood draw #1 Site of blood draw: IMU Volume of blood: 20mL Purpose of blood draw: Isolation of genomic DNA Site of storage: NHRIS biobank Coding: Specimens will be identified using a research ID that will be affixed to samples using bar-coding. After the blood is collected, stored the blood at 4 degree Celsius and contact the NHCS biobank coordinator to collect the blood samples. The blood samples must be collected within 1 hour of collection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with deleterious mutations in the PRDM-16 locus, using standard genomic methods
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 posted22 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MutationStudies 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
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Tan Ru San, MBBS, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808715
- Sponsor's protocol ID
- 2014/337/C
- Status last verified
- May 2016
- First submitted
- 31 May 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Metabolic Characterization of a Cohort of Human Subjects With Mutations in PRDM-16
- ClinicalTrials.gov ID
- NCT02808715
- Acronym / sponsor ID
- 2014/337/C
- Conditions
- Mutation, Obesity, Dyslipidemia, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Singapore General Hospital
- Study start
- May 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Jun 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.
Chinese male subjects will be invited to participate in a research study of brown fat, a special tissue in the body that is designed to burn energy to make heat. The objective is to learn the importance of a gene called "PRDM-16" for the function of brown fat. Subjects were selected as a possible subject in this study because they fulfil the age and weight criteria.
500 subjects from the Singhealth Investigational Medicine Unit healthy volunteer database will be recruited over a period of 2 years. All of the subjects will have their PRDM-16 gene sequenced. The objective is to identify subjects with mutations, or changes, in their PRDM-16 gene. About 12 subjects with PRDM-16 mutations are expected to be identified.
Samples of blood obtained during the course of this study will be stored and analysed only for the purposes of this study for a period not exceeding 2 years, and will be destroyed after completion of the study, unless subject is agreeable to donate the samples to the National Heart Centre Singapore for continuous storage for future studies that are approved by the institutional review board..
Detailed description
The long-term objective of this study is to develop new treatments for obesity and obesity-associated disorders such as diabetes and dyslipidemia. The recent finding of active brown fat depots in adult humans provides an exciting new strategy for the treatment of these diseases. Brown fat is a specialized organ found primarily in small mammals. Brown fat has the unique capability to burn fuel at high rates in order to generate heat. The role of brown fat in mammals is to defend against cold exposure. Human infants have active brown fat deposits located in the intra-scapular region. This brown fat depot regresses with age and it was long thought that adult humans had no brown fat tissue. Recent studies have demonstrated the presence of brown fat activity in adult humans following exposure to cold. Brown fat in adult humans is concentrated in the cervical region and displays some sex-specific differences. Furthermore the size of the depot is inversely correlated with BMI and age of the subjects. This finding has generated intense interest as it opens up the possibility of harnessing brown fat as a means of combating obesity and obesity-related disorders in man. Indeed, maneuvers that activate brown fat in humans have been shown to cause reductions in fat mass.
Much of our understanding of brown fat biology comes from work in mice. Of particular relevance for the treatment of human disease are several findings. First, increasing brown fat activity in mice renders the animals resistant to the development of obesity on a high fat diet. Second, levels of insulin sensitivity are directly related to brown fat activity. Finally, the transcription factor factor PR-domain containing protein 16 (PRDM-16) is crucial for directing the biology of brown fat.
The overall goal of the study is to translate the findings from mouse studies of brown fat into human subjects. This is an important first step in the process of developing brown fat-targeted therapies to treat human metabolic diseases such as obesity and insulin resistance. In view of this the investigators are interested in answering several questions. First, do humans with mutations in PRDM-16 have defects in brown fat activity? Recently, humans with mutations in PRDM-16 were identified and found to have a cardiomyopathy phenotype. The brown fat function in these individuals has not been described. By employing a genetic screen of volunteers the investigators hope to identify subjects in Singapore with defects in PRDM-16. Prior studies in humans suggest that the size of the brown fat depot is inversely correlated with BMI and age of the subjects and that depot size varies between the sexes. In order to eliminate BMI, age and sex as confounding variables the investigators will include male subjects of Chinese race between the ages of 21 and 50 and with BMI greater than 18.5 but less than 30. The investigators will include only Chinese subjects to avoid confounding our initial study with variables that relate to race of the subjects. The identification of human subjects carrying mutations in PRDM-16 will set the stage for further studies that will attempt to several research questions. These include whether humans with PRDM-16 mutations have defects in brown fat and the metabolic consequences for humans with defective brown fat.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 500 subjects will be recruited from the IMU healthy volunteer database. The investigators will enroll male Chinese volunteers. Women, children and the elderly are excluded from our initial study since prior research suggests that age and sex has an effect on brown fat function. In order to study the role of PRDM-16 in brown fat function the investigators wish to keep other contributing variables static in our study.
Key inclusion criteria (7 listed)
- Male
- Chinese
- Age >= 21 and =< 50
- BMI >=18.5 and =< 30
- Ability to provide written, informed consent.
Key exclusion criteria (3 listed)
- Diagnosis of DM2
- Use of beta blockers, TZD (ie rosiglitazone/pioglitazone) or metformin Since the subjects will be recruited from the IMU healthy volunteer database there should be no prior history of DM2 or medication use. Nevertheless, diagnosis of DM2 and use of the drugs listed can alter brown fat activity and interfere with our analysis.
- Presence of pacemakers or foreign metallic objects in the eyes. Future planned experiments with the identified cohort include cardiac MRI. Subjects with pacemakers or foreign metallic objects in the eyes will be ineligible for this potential follow-up study.
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 |
|---|---|---|
| Blood Sample CollectionBlood draw #1 Site of blood draw: IMU Volume of blood: 20mL Purpose of blood draw: Isolation of genomic DNA Site of storage: NHRIS biobank Coding: Specimens will be identified using a research ID that will be affixed to samples using bar-coding. After the blood is collected, stored the blood at 4 degree Celsius and contact the NHCS biobank coordinator to collect the blood samples. The blood samples must be collected within 1 hour of collection. | Other | – |
Primary outcome
Number of participants with deleterious mutations in the PRDM-16 locus, using standard genomic methods
Time frame: 1 year
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 22 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Tan Ru San, MBBS principal investigator
National Heart Centre Singapore
Questions about this trial
What is this clinical trial studying?
An observational study of Mutation and Obesity, run by National Heart Centre Singapore.
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 7 inclusion and 3 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 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants with deleterious mutations in the PRDM-16 locus, using standard genomic methods (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2016.