ObesityNCT03229044
Tetranectin as a Novel Obesity-associated Adipokine for Regulating Lipid Accumulation
An observational study of Obesity and Metabolic Syndrome, run by National Taiwan University Hospital.
Trial summary
Adipose tissue is strongly correlated to obesity and diabetes which are two major problems in the worldwide. Adipose tissue is involved in modulating glucose and energy metabolism locally and systemically by secreting factors, called adipocytokines. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Tetranectin
- How many people
- 289 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2005to 5 Dec 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage.
Who may be able to join
- Must be above age 20 years old.
- Subjects must sign the written informed consent form.
- Must have residual fat after surgery.
- Clinical diagnosis of liposuction and tumor resection.
Who cannot join
- Terminal cancer.
- Subjects have no fat tissue after surgery.
- Pregnant subjects.
About this study
Adipose tissue is strongly correlated to obesity and diabetes which are two major problems in the worldwide. Adipose tissue is involved in modulating glucose and energy metabolism locally and systemically by secreting factors, called adipocytokines. Tetranectin (TN), a novel adipocytokine, is secreted by adipose tissues. TN may regulate the glucose/energy homeostasis to affect lipid accumulation.The role of TN in adipocytes with or without TN on regulation of adipose tissue growth and lipid metabolism is valuable to be studied.
Materials and methods: Secreted proteins from human adipocyte culture medium were deciphered using 2-D polyacrylamide gel electrophoresis and determined by LC/MS with MALDI-TOF analysis of proteins. Adipose tissues were obtained from the breast of 15 women undergoing mastectomy. Serum samples from 200 normal healthy people and 54 breast cancer patients were assigned to either a lean or obese group according to the body mass index. The TN protein concentration was measured in the culture medium of stromal-vascular fraction (SVF)-derived adipocytes from healthy humans, breast cancer patients, pigs and also from 3T3-L1 cells. Associations between plasma TN and other biomarkers were assessed with Pearson's correlations and multivariable linear regression.
Read the detailed description
Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage. All participants gave permission and the study was approved by the Ethics Committee of National Taiwan University Hospital as no. 9461701203.
From 2012 to 2013 in National Taiwan University Hospital, a cross-sectional sampling of 21 to 78 -year old people included women and men who were living in Taiwan. Blood samples were collected after an overnight fasting. Serum was separated by centrifugation and stored at -80 ℃ until analysis. Plasma triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), cholesterol, glucose and insulin were measured. Fasting serum samples were obtained from 193 randomly selected persons having health check-ups. To investigate the relationship among TN and breast cancer, fasting serum samples also obtained from 54 randomly selected breast cancer patients who were 25 to 59 years old with elected surgery for breast cancer stage 0 and 1.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Tetranectin
- Keywords
- adipokine, tetranectin, lipid metabolism, body mass index
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetranectinGenetic
Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage. The subjects were 33-51 y of age (mean = 43.6, SD = 6.2) with a BMI of 16-33 kg/m2 (mean = 21.5, SD = 4.5). Blood samples were collected after an overnight fasting. Serum was separated by centrifugation and stored at -80 ℃ until analysis. Plasma Tetranectin,triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), cholesterol, glucose and insulin were measured. And the tetranectin mRNA and protein level was measure in adipose tissue
| Study group | Role | What they receive |
|---|---|---|
| BMI 18-21 | Tetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 18-21 kg/m2 Receives: Genetic: Tetranectin | |
| BMI 33-39 | Tetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 33-39 kg/m2 Receives: Genetic: Tetranectin | |
| BMI 25-30 | Tetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 25-30 kg/m2 Receives: Genetic: Tetranectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tetranectin expression measure
Detect Tetranectin expression in adipose tissue by qPCR or Western blotting
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start6 Dec 2005
- Primary completion5 Dec 2008
- Study completion5 Dec 2008
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shih-Torng Ding, Ph D, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229044
- Sponsor's protocol ID
- 9461701203
- Status last verified
- Dec 2005
- First submitted
- 13 Jul 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Serum samples and adipose tissue from breast cancer patients were assigned to either a lean or obese group according to the body mass index. The TN protein concentration was measured in the serum samples and culture medium of stromal-vascular fraction (SVF)-derived adipocytes from breast cancer patients,
Publications
Jaquinod M, Holtet TL, Etzerodt M, Clemmensen I, Thogersen HC, Roepstorff P. Mass spectrometric characterisation of post-translational modification and genetic variation in human tetranectin. Biol Chem. 1999 Nov;380(11):1307-14. doi: 10.1515/BC.1999.166.
PubMed 10614823Iba K, Durkin ME, Johnsen L, Hunziker E, Damgaard-Pedersen K, Zhang H, Engvall E, Albrechtsen R, Wewer UM. Mice with a targeted deletion of the tetranectin gene exhibit a spinal deformity. Mol Cell Biol. 2001 Nov;21(22):7817-25. doi: 10.1128/MCB.21.22.7817-7825.2001.
PubMed 11604516
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tetranectin as a Novel Obesity-associated Adipokine for Regulating Lipid Accumulation
- ClinicalTrials.gov ID
- NCT03229044
- Acronym / sponsor ID
- 9461701203
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- adipokine, tetranectin, lipid metabolism, body mass index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Dec 2005 (actual)
- Primary completion
- 5 Dec 2008 (actual)
- Study completion
- 5 Dec 2008 (actual)
- First posted
- 25 Jul 2017 (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.
Adipose tissue is strongly correlated to obesity and diabetes which are two major problems in the worldwide. Adipose tissue is involved in modulating glucose and energy metabolism locally and systemically by secreting factors, called adipocytokines. Tetranectin (TN), a novel adipocytokine, is secreted by adipose tissues. TN may regulate the glucose/energy homeostasis to affect lipid accumulation.The role of TN in adipocytes with or without TN on regulation of adipose tissue growth and lipid metabolism is valuable to be studied.
Materials and methods: Secreted proteins from human adipocyte culture medium were deciphered using 2-D polyacrylamide gel electrophoresis and determined by LC/MS with MALDI-TOF analysis of proteins. Adipose tissues were obtained from the breast of 15 women undergoing mastectomy. Serum samples from 200 normal healthy people and 54 breast cancer patients were assigned to either a lean or obese group according to the body mass index. The TN protein concentration was measured in the culture medium of stromal-vascular fraction (SVF)-derived adipocytes from healthy humans, breast cancer patients, pigs and also from 3T3-L1 cells. Associations between plasma TN and other biomarkers were assessed with Pearson's correlations and multivariable linear regression.
Detailed description
Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage. All participants gave permission and the study was approved by the Ethics Committee of National Taiwan University Hospital as no. 9461701203.
From 2012 to 2013 in National Taiwan University Hospital, a cross-sectional sampling of 21 to 78 -year old people included women and men who were living in Taiwan. Blood samples were collected after an overnight fasting. Serum was separated by centrifugation and stored at -80 ℃ until analysis. Plasma triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), cholesterol, glucose and insulin were measured. Fasting serum samples were obtained from 193 randomly selected persons having health check-ups. To investigate the relationship among TN and breast cancer, fasting serum samples also obtained from 54 randomly selected breast cancer patients who were 25 to 59 years old with elected surgery for breast cancer stage 0 and 1.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMI 18-21 | – | Genetic: TetranectinTetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 18-21 kg/m2 |
| BMI 33-39 | – | Genetic: TetranectinTetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 33-39 kg/m2 |
| BMI 25-30 | – | Genetic: TetranectinTetranectin mRNA and protein level were measure in the adipose tissues which were belonging to body mass index is 25-30 kg/m2 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage.
Key inclusion criteria (4 listed)
- Must be above age 20 years old.
- Subjects must sign the written informed consent form.
- Must have residual fat after surgery.
- Clinical diagnosis of liposuction and tumor resection.
Key exclusion criteria (3 listed)
- Terminal cancer.
- Subjects have no fat tissue after surgery.
- Pregnant subjects.
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 |
|---|---|---|
| TetranectinAdipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage. The subjects were 33-51 y of age (mean = 43.6, SD = 6.2) with a BMI of 16-33 kg/m2 (mean = 21.5, SD = 4.5). Blood samples were collected after an overnight fasting. Serum was separated by centrifugation and stored at -80 ℃ until analysis. Plasma Tetranectin,triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), cholesterol, glucose and insulin were measured. And the tetranectin mRNA and protein level was measure in adipose tissue | Genetic | BMI 18-21, BMI 25-30, BMI 33-39 |
Primary outcome
Tetranectin expression measure
Time frame: through study completion, an average of 2 years
Detect Tetranectin expression in adipose tissue by qPCR or Western blotting
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 28 Jul 2017.
- Background: PubMed 10614823Jaquinod M, Holtet TL, Etzerodt M, Clemmensen I, Thogersen HC, Roepstorff P. Mass spectrometric characterisation of post-translational modification and genetic variation in human tetranectin. Biol Chem. 1999 Nov;380(11):1307-14. doi: 10.1515/BC.1999.166.
- Background: PubMed 11604516Iba K, Durkin ME, Johnsen L, Hunziker E, Damgaard-Pedersen K, Zhang H, Engvall E, Albrechtsen R, Wewer UM. Mice with a targeted deletion of the tetranectin gene exhibit a spinal deformity. Mol Cell Biol. 2001 Nov;21(22):7817-25. doi: 10.1128/MCB.21.22.7817-7825.2001.
- Individual participant dataSharing planned: Undecided. Serum samples and adipose tissue from breast cancer patients were assigned to either a lean or obese group according to the body mass index. The TN protein concentration was measured in the serum samples and culture medium of stromal-vascular fraction (SVF)-derived adipocytes from breast cancer patients,
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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.
Shih-Torng Ding, Ph D principal investigator
National Taiwan University
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Metabolic Syndrome, run by National Taiwan University Hospital.
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 4 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 28 Jul 2017. 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?
Tetranectin expression measure (time frame: through study completion, an average of 2 years). 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 NCT03229044, 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 28 Jul 2017.