Diabetes MellitusNCT00975169
Association Study of Genetic Polymorphisms of Candidate Genes With Thiazolidinedione-Related Peripheral Edema and Drug Responsiveness
An observational study of Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
According to the above evidence, though the exact mechanism contributing to the Thiazolidinediones (TZDs) associated peripheral edema is still unclear, the investigators hypothesize that the genetic variations of certain candidate genes involved in peroxisome proliferator-activated receptor (PPAR) gamma itself and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2009to Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: TZDs User, no insulin; CHF, according to New York heart Association III-V, liver cirrhosis or renal insufficiency (Cr ≥ 1.7 mg/dL) before initiation of treatment with TZDs will be excluded.
Who may be able to join
- Clinical diagnosis of DM and with use TZDs
Who cannot join
- Patients with the diagnosis of congestive heart failure
- Liver cirrhosis (according to abdominal echo)
- Renal insufficiency (Cr ≥ 1.7 mg/dL)
- Patient with concomitant use of insulin, and/or diuretics before TZDs were excluded
- Pregnant
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, National Taiwan University Hospital
Taipei
Linda Huang, 886 9 67670020, linda590203@gmail.com
Tien-Jyun Chang, Ph D
About this study
According to the above evidence, though the exact mechanism contributing to the Thiazolidinediones (TZDs) associated peripheral edema is still unclear, the investigators hypothesize that the genetic variations of certain candidate genes involved in peroxisome proliferator-activated receptor (PPAR) gamma itself and PPAR gamma-regulated genes may contribute to TZDs-associated peripheral edema. Therefore, the investigators plan to conduct a case-control study to test the association between single nucleotide polymorphisms (SNPs) in certain candidate genes and TZDs related peripheral edema.
A large fraction of individuals, both with type 2 diabetes (38-41) or who are at risk for type 2 diabetes, do not respond to TZD therapy. In individuals with type 2 diabetes, non-response has not been carefully characterized, but data from studies in at-risk individuals suggests that a lack of improvement in insulin sensitivity (Si) may account for the lack of response to TZD therapy. In the Troglitazone In the Prevention Of Diabetes (TRIPOD) study, around 30% of treated women did not show an improvement in Si; they gained no protection from type 2 diabetes when compared with the placebo group. Assessment of baseline clinical and physiologic measurements revealed similar levels of adiposity, fasting glucose and insulin, Si and β-cell function, fasting lipids, contraceptive use, and compliance with study medication between responders and nonresponders, suggesting that these measures do not predict TZD response.
Read more
The adipose tissue-derived hormone adiponectin improves insulin sensitivity and its circulating levels are decreased in obesity induced insulin resistance. In ob/ob mice lacking adiponectin, the ability of PPARγ agonists, TZDs, to improve glucose tolerance is diminished. It implied that adiponectin is an important contributor to PPARγ-mediated improvements in glucose tolerance through mechanisms that involve the activation of the AMPK pathway. On the other hand, it has been shown that FOXO1 repressed PPARγ1 and γ2 promoters in primary adipocytes. It has also been reported that peroxisome proliferators activated receptor-γ coactivator-1α (PGC-1α) gene expression in brown and white adipocytes is a direct target of TZDs and activators of retinoid X receptor (RXR). Taken together, both FOXO1 and PGC-1α potentially played important roles on the antidiabetic action of TZDs.
In summary, though TZDs have been widely used in patients with type 2 diabetes mellitus, some of patients experienced TZD-related peripheral edema and some of patients had no good responsiveness to TZDs. The underlying contributing factors and molecular mechanisms have not been clearly elucidated. In this study, the investigators will identify the contributing factors of TZD-related peripheral edema and responsiveness to TZDs. The investigators will also identify the association of single nucleotide polymorphisms (SNPs) of certain candidate genes with TZD related peripheral edema and responsiveness to TZDs. It may identify some clinical and pharmacogenetic factors to predict the occurrence of TZD-related edema and the responsiveness to TZDs.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TZDs User | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
we plan to conduct a case-control study to test the association between single nucleotide polymorphisms (SNPs) in certain candidate genes and TZDs related peripheral edema
Measured: 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tien-Jyun Chang, Ph D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975169
- Sponsor's protocol ID
- 200902005R
- Status last verified
- Mar 2010
- First submitted
- 10 Sep 2009
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Study of Genetic Polymorphisms of Candidate Genes With Thiazolidinedione-Related Peripheral Edema and Drug Responsiveness
- ClinicalTrials.gov ID
- NCT00975169
- Acronym / sponsor ID
- 200902005R
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 11 Sep 2009 (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.
According to the above evidence, though the exact mechanism contributing to the Thiazolidinediones (TZDs) associated peripheral edema is still unclear, the investigators hypothesize that the genetic variations of certain candidate genes involved in peroxisome proliferator-activated receptor (PPAR) gamma itself and PPAR gamma-regulated genes may contribute to TZDs-associated peripheral edema. Therefore, the investigators plan to conduct a case-control study to test the association between single nucleotide polymorphisms (SNPs) in certain candidate genes and TZDs related peripheral edema.
A large fraction of individuals, both with type 2 diabetes (38-41) or who are at risk for type 2 diabetes, do not respond to TZD therapy. In individuals with type 2 diabetes, non-response has not been carefully characterized, but data from studies in at-risk individuals suggests that a lack of improvement in insulin sensitivity (Si) may account for the lack of response to TZD therapy. In the Troglitazone In the Prevention Of Diabetes (TRIPOD) study, around 30% of treated women did not show an improvement in Si; they gained no protection from type 2 diabetes when compared with the placebo group. Assessment of baseline clinical and physiologic measurements revealed similar levels of adiposity, fasting glucose and insulin, Si and β-cell function, fasting lipids, contraceptive use, and compliance with study medication between responders and nonresponders, suggesting that these measures do not predict TZD response.
The adipose tissue-derived hormone adiponectin improves insulin sensitivity and its circulating levels are decreased in obesity induced insulin resistance. In ob/ob mice lacking adiponectin, the ability of PPARγ agonists, TZDs, to improve glucose tolerance is diminished. It implied that adiponectin is an important contributor to PPARγ-mediated improvements in glucose tolerance through mechanisms that involve the activation of the AMPK pathway. On the other hand, it has been shown that FOXO1 repressed PPARγ1 and γ2 promoters in primary adipocytes. It has also been reported that peroxisome proliferators activated receptor-γ coactivator-1α (PGC-1α) gene expression in brown and white adipocytes is a direct target of TZDs and activators of retinoid X receptor (RXR). Taken together, both FOXO1 and PGC-1α potentially played important roles on the antidiabetic action of TZDs.
In summary, though TZDs have been widely used in patients with type 2 diabetes mellitus, some of patients experienced TZD-related peripheral edema and some of patients had no good responsiveness to TZDs. The underlying contributing factors and molecular mechanisms have not been clearly elucidated. In this study, the investigators will identify the contributing factors of TZD-related peripheral edema and responsiveness to TZDs. The investigators will also identify the association of single nucleotide polymorphisms (SNPs) of certain candidate genes with TZD related peripheral edema and responsiveness to TZDs. It may identify some clinical and pharmacogenetic factors to predict the occurrence of TZD-related edema and the responsiveness to TZDs.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TZDs User | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- TZDs User, no insulin; CHF, according to New York heart Association III-V, liver cirrhosis or renal insufficiency (Cr ≥ 1.7 mg/dL) before initiation of treatment with TZDs will be excluded.
Key inclusion criteria (1 listed)
- Clinical diagnosis of DM and with use TZDs
Key exclusion criteria (5 listed)
- Patients with the diagnosis of congestive heart failure
- Liver cirrhosis (according to abdominal echo)
- Renal insufficiency (Cr ≥ 1.7 mg/dL)
- Patient with concomitant use of insulin, and/or diuretics before TZDs were excluded
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
we plan to conduct a case-control study to test the association between single nucleotide polymorphisms (SNPs) in certain candidate genes and TZDs related peripheral edema
Time frame: 34 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
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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.
Tien-Jyun Chang, Ph D principal investigator
National Taiwan 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 Diabetes Mellitus, run by National Taiwan University Hospital 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 1 inclusion and 5 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 18 Mar 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Huang (886 9 37670020, linda590203@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
we plan to conduct a case-control study to test the association between single nucleotide polymorphisms (SNPs) in certain candidate genes and TZDs related peripheral edema (time frame: 34 weeks). 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 18 Mar 2010.