Diabetes MellitusNCT01372852
Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Xijing Hospital at 1 site in China.
Trial summary
The objective of present study were to compare plasma adiponectin isoform status, their bioactivities newly diagnosed Chinese with healthy volunteer. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2010to 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study enrolls a group of 30-70years patients from primary care clinic who have diabetes history within 12 months and without taking any treatment.
Who may be able to join
- Having a diabetic history within 12 months
- BMI smaller than 30kg/m2
Who cannot join
- Having any kinds of treatment affecting glucose
- pregnant
- uncontrolled hypertension, active cardiac disease, or other major liver, kidney disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Ling Tao, MD,PhD, +86-15002955798, lingtao2006@gmail.com
About this study
Official title: Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated T2DM Patients in Chinese Population
The objective of present study were to compare plasma adiponectin isoform status, their bioactivities newly diagnosed Chinese with healthy volunteer.
Read the detailed description
Adiponectin, circulates as trimer, hexamer and high molecular weight form (HMW) in human blood, is a promising biomarker for indication diabetes and cardiovascular disease. Both adiponectin complexes concentration and their bioactivities are decreased in pathological state. Disulfide-bond A oxidoreductase-like protein (DsbA-L) is a key regulator for adiponectin biosynthesis and its expression level is down-regulated in obese mice and humans. However, the alteration of circulating adiponectin multimers distribution, their bioactivities and adiponectin regulator, DsbA-L level, in newly diagnosed Chinese type 2 diabetes patients are unknown. The objective of present study were to compare plasma adiponectin isoform status, their bioactivities and DsbA-L concentration in newly diagnosed Chinese with healthy volunteer.
- Conditions
- Diabetes Mellitus
- Keywords
- 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 |
|---|---|---|
| T2DM patients | newly diagnosed T2DM patients and untreated with any drugs. | |
| Non-diabetic Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma adiponectin concentration, isoform distribution and activity.
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMay 2010
- Primary completionOct 2011 (estimated)
- Study 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 Xijing 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ling Tao, M.D Ph.D, Principal investigator, Department of Cardiology of Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372852
- Sponsor's protocol ID
- xjyy110501
- Status last verified
- May 2010
- First submitted
- 11 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated T2DM Patients in Chinese Population
- ClinicalTrials.gov ID
- NCT01372852
- Acronym / sponsor ID
- xjyy110501
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 14 Jun 2011 (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.
The objective of present study were to compare plasma adiponectin isoform status, their bioactivities newly diagnosed Chinese with healthy volunteer.
Detailed description
Adiponectin, circulates as trimer, hexamer and high molecular weight form (HMW) in human blood, is a promising biomarker for indication diabetes and cardiovascular disease. Both adiponectin complexes concentration and their bioactivities are decreased in pathological state. Disulfide-bond A oxidoreductase-like protein (DsbA-L) is a key regulator for adiponectin biosynthesis and its expression level is down-regulated in obese mice and humans. However, the alteration of circulating adiponectin multimers distribution, their bioactivities and adiponectin regulator, DsbA-L level, in newly diagnosed Chinese type 2 diabetes patients are unknown. The objective of present study were to compare plasma adiponectin isoform status, their bioactivities and DsbA-L concentration in newly diagnosed Chinese with healthy volunteer.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM patients | – | –newly diagnosed T2DM patients and untreated with any drugs. |
| Non-diabetic Control Group | – | – |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolls a group of 30-70years patients from primary care clinic who have diabetes history within 12 months and without taking any treatment.
Key inclusion criteria (2 listed)
- Having a diabetic history within 12 months
- BMI smaller than 30kg/m2
Key exclusion criteria (3 listed)
- Having any kinds of treatment affecting glucose
- pregnant
- uncontrolled hypertension, active cardiac disease, or other major liver, kidney disease
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
plasma adiponectin concentration, isoform distribution and activity.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
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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.
Ling Tao, M.D Ph.D principal investigator
Department of Cardiology of Xijing Hospital, Fourth Military Medical University
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 Xijing Hospital at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 14 Jun 2011. 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 China. 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 Ling Tao, M.D Ph.D (+86-15002955798, lingtao2006@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma adiponectin concentration, isoform distribution and activity. (time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week). 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 14 Jun 2011.