Morbid ObesityNCT01684280
Obesity-related Genes in Taiwanese Undergoing Weight Loss
An observational study of Morbid Obesity, run by Sung Ling Yeh at 1 site in Taiwan.
Trial summary
To investigate: 1. Associations between miRNA and insulin signaling-related gene expressions in abdominal adipose tissues in obese subjects. 2. Differences in miRNAs expressed by intrabdominal omental adipose tissues between genders. Read more about this study
- Who is it for?
- Ages 19 to 63 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- gender
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2010to Sep 2010
- 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 19 to 63 years
- All sexes
- No healthy volunteers
- Adult
Study population: Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men (n = 9) and women (n =10) who underwent bariatric surgery. Their BMI were all over 40 kg/ m2, and ages between 19-63 years.
Who may be able to join
- Morbid obesity,BMIs> 40 kg/m2
- Subjects who underwent bariatric surgery
Who cannot join
- Obese subjects with complicated metabolic disorders
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Searching for the Most Influential Obesity-related Diabetic Genes and Exploring the Expression Profiles of Those Genes in Taiwanese Undergoing Weight Loss
To investigate:
- Associations between miRNA and insulin signaling-related gene expressions in abdominal adipose tissues in obese subjects.
- Differences in miRNAs expressed by intrabdominal omental adipose tissues between genders.
Read the detailed description
Compared the differences in microRNA expressions of abdominal adipose tissue in morbid obese male and female subjects to elucidate the possible regulatory role of microRNA in insulin signaling-related gene expression levels and its association with biochemical markers. We hope to find a miRNA that can be used to predict the syndrome associated with obesity.
- Conditions
- Morbid Obesity
- Being tested
- gender
- Keywords
- abdominal adipose tissue; microRNA
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genderGenetic
Also called BMI were all over 40 kg/ m2
Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| gender | Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery. Receives: Genetic: gender |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicroRNA expression in abdominal omental adipose tissues
MicroRNA-125a-3p expression in abdominal omental adipose tissues is associated with insulin signaling-related gene expression levels in morbid obesity
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Morbid 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sung Ling Yeh
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor-investigator, Sung Ling Yeh, Taipei Medical University Hospital
- Investigators
- Wang Weu, Study director, Comprehensive Weight Management Center Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684280
- Sponsor's protocol ID
- CRC-06-09-10
- Status last verified
- Sep 2012
- First submitted
- 10 Sep 2012
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brennecke J, Stark A, Russell RB, Cohen SM. Principles of microRNA-target recognition. PLoS Biol. 2005 Mar;3(3):e85. doi: 10.1371/journal.pbio.0030085.
PubMed 15723116Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.
PubMed 14744438Hilton C, Neville MJ, Karpe F. MicroRNAs in adipose tissue: their role in adipogenesis and obesity. Int J Obes (Lond). 2013 Mar;37(3):325-32. doi: 10.1038/ijo.2012.59. Epub 2012 Apr 24.
PubMed 22531086Krotkiewski M, Bjorntorp P, Sjostrom L, Smith U. Impact of obesity on metabolism in men and women. Importance of regional adipose tissue distribution. J Clin Invest. 1983 Sep;72(3):1150-62. doi: 10.1172/JCI111040.
PubMed 6350364Jiang L, Huang Q, Zhang S, Zhang Q, Chang J, Qiu X, Wang E. Hsa-miR-125a-3p and hsa-miR-125a-5p are downregulated in non-small cell lung cancer and have inverse effects on invasion and migration of lung cancer cells. BMC Cancer. 2010 Jun 22;10:318. doi: 10.1186/1471-2407-10-318.
PubMed 20569443Herrera BM, Lockstone HE, Taylor JM, Wills QF, Kaisaki PJ, Barrett A, Camps C, Fernandez C, Ragoussis J, Gauguier D, McCarthy MI, Lindgren CM. MicroRNA-125a is over-expressed in insulin target tissues in a spontaneous rat model of Type 2 Diabetes. BMC Med Genomics. 2009 Aug 18;2:54. doi: 10.1186/1755-8794-2-54.
PubMed 19689793John B, Enright AJ, Aravin A, Tuschl T, Sander C, Marks DS. Human MicroRNA targets. PLoS Biol. 2004 Nov;2(11):e363. doi: 10.1371/journal.pbio.0020363. Epub 2004 Oct 5.
PubMed 15502875Kanehisa M, Goto S. KEGG: kyoto encyclopedia of genes and genomes. Nucleic Acids Res. 2000 Jan 1;28(1):27-30. doi: 10.1093/nar/28.1.27.
PubMed 10592173Gustafson B. Adipose tissue, inflammation and atherosclerosis. J Atheroscler Thromb. 2010 Apr 30;17(4):332-41. doi: 10.5551/jat.3939. Epub 2010 Feb 3.
PubMed 20124732O'Connell J, Lynch L, Cawood TJ, Kwasnik A, Nolan N, Geoghegan J, McCormick A, O'Farrelly C, O'Shea D. The relationship of omental and subcutaneous adipocyte size to metabolic disease in severe obesity. PLoS One. 2010 Apr 1;5(4):e9997. doi: 10.1371/journal.pone.0009997.
PubMed 20376319Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.
PubMed 15864338Niswender KD, Morrison CD, Clegg DJ, Olson R, Baskin DG, Myers MG Jr, Seeley RJ, Schwartz MW. Insulin activation of phosphatidylinositol 3-kinase in the hypothalamic arcuate nucleus: a key mediator of insulin-induced anorexia. Diabetes. 2003 Feb;52(2):227-31. doi: 10.2337/diabetes.52.2.227.
PubMed 12540590
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for the Most Influential Obesity-related Diabetic Genes and Exploring the Expression Profiles of Those Genes in Taiwanese Undergoing Weight Loss
- ClinicalTrials.gov ID
- NCT01684280
- Acronym / sponsor ID
- CRC-06-09-10
- Conditions
- Morbid Obesity
- Keywords
- abdominal adipose tissue; microRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sung Ling YehUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Sep 2012 (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.
To investigate:
- Associations between miRNA and insulin signaling-related gene expressions in abdominal adipose tissues in obese subjects.
- Differences in miRNAs expressed by intrabdominal omental adipose tissues between genders.
Detailed description
Compared the differences in microRNA expressions of abdominal adipose tissue in morbid obese male and female subjects to elucidate the possible regulatory role of microRNA in insulin signaling-related gene expression levels and its association with biochemical markers. We hope to find a miRNA that can be used to predict the syndrome associated with obesity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gender | – | Genetic: genderPaired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery. |
Who may qualify
- Ages
- 19 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men (n = 9) and women (n =10) who underwent bariatric surgery. Their BMI were all over 40 kg/ m2, and ages between 19-63 years.
Key inclusion criteria (2 listed)
- Morbid obesity,BMIs> 40 kg/m2
- Subjects who underwent bariatric surgery
Key exclusion criteria (2 listed)
- Obese subjects with complicated metabolic disorders
- Thyroid disease
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 |
|---|---|---|
| genderAlso: BMI were all over 40 kg/ m2Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery. | Genetic | gender |
Primary outcome
MicroRNA expression in abdominal omental adipose tissues
Time frame: up to 28 weeks
MicroRNA-125a-3p expression in abdominal omental adipose tissues is associated with insulin signaling-related gene expression levels in morbid obesity
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 13 Sep 2012.
- Background: PubMed 15723116Brennecke J, Stark A, Russell RB, Cohen SM. Principles of microRNA-target recognition. PLoS Biol. 2005 Mar;3(3):e85. doi: 10.1371/journal.pbio.0030085.
- Background: PubMed 14744438Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.
- Background: PubMed 22531086Hilton C, Neville MJ, Karpe F. MicroRNAs in adipose tissue: their role in adipogenesis and obesity. Int J Obes (Lond). 2013 Mar;37(3):325-32. doi: 10.1038/ijo.2012.59. Epub 2012 Apr 24.
- Background: PubMed 6350364Krotkiewski M, Bjorntorp P, Sjostrom L, Smith U. Impact of obesity on metabolism in men and women. Importance of regional adipose tissue distribution. J Clin Invest. 1983 Sep;72(3):1150-62. doi: 10.1172/JCI111040.
- Results publication: PubMed 20569443Jiang L, Huang Q, Zhang S, Zhang Q, Chang J, Qiu X, Wang E. Hsa-miR-125a-3p and hsa-miR-125a-5p are downregulated in non-small cell lung cancer and have inverse effects on invasion and migration of lung cancer cells. BMC Cancer. 2010 Jun 22;10:318. doi: 10.1186/1471-2407-10-318.
- Results publication: PubMed 19689793Herrera BM, Lockstone HE, Taylor JM, Wills QF, Kaisaki PJ, Barrett A, Camps C, Fernandez C, Ragoussis J, Gauguier D, McCarthy MI, Lindgren CM. MicroRNA-125a is over-expressed in insulin target tissues in a spontaneous rat model of Type 2 Diabetes. BMC Med Genomics. 2009 Aug 18;2:54. doi: 10.1186/1755-8794-2-54.
- Results publication: PubMed 15502875John B, Enright AJ, Aravin A, Tuschl T, Sander C, Marks DS. Human MicroRNA targets. PLoS Biol. 2004 Nov;2(11):e363. doi: 10.1371/journal.pbio.0020363. Epub 2004 Oct 5.
- Results publication: PubMed 10592173Kanehisa M, Goto S. KEGG: kyoto encyclopedia of genes and genomes. Nucleic Acids Res. 2000 Jan 1;28(1):27-30. doi: 10.1093/nar/28.1.27.
- Results publication: PubMed 20124732Gustafson B. Adipose tissue, inflammation and atherosclerosis. J Atheroscler Thromb. 2010 Apr 30;17(4):332-41. doi: 10.5551/jat.3939. Epub 2010 Feb 3.
- Results publication: PubMed 20376319O'Connell J, Lynch L, Cawood TJ, Kwasnik A, Nolan N, Geoghegan J, McCormick A, O'Farrelly C, O'Shea D. The relationship of omental and subcutaneous adipocyte size to metabolic disease in severe obesity. PLoS One. 2010 Apr 1;5(4):e9997. doi: 10.1371/journal.pone.0009997.
- Results publication: PubMed 15864338Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.
- Results publication: PubMed 12540590Niswender KD, Morrison CD, Clegg DJ, Olson R, Baskin DG, Myers MG Jr, Seeley RJ, Schwartz MW. Insulin activation of phosphatidylinositol 3-kinase in the hypothalamic arcuate nucleus: a key mediator of insulin-induced anorexia. Diabetes. 2003 Feb;52(2):227-31. doi: 10.2337/diabetes.52.2.227.
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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.
Wang Weu study director
Comprehensive Weight Management Center Taipei Medical University 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 Morbid Obesity, run by Sung Ling Yeh at 1 site in Taiwan.
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 2 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 13 Sep 2012. 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 Taiwan. 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?
MicroRNA expression in abdominal omental adipose tissues (time frame: up to 28 weeks). 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 NCT01684280, which also lists 12 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 13 Sep 2012; AzTrials last refreshed its copy on 7 Nov 2026.