ObeseNCT00561704
Adiponectin in Obese Women With T2DN and Effects by RAS Blocker
A study testing losartan in people with Obese and Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Insulin resistance typically characterizes type 2 diabetes (T2DM) and prediabetic states and is the prominent feature of the metabolic syndrome.Adiponectin plays an important part in glucose metabolism,insulin resistance, the deterioration of renal function.we hypothesize there is a difference serum adiponectin levels… Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Obese, Type 2 Diabetes, Diabetic Nephropathy
- What is being tested?
- losartan
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Oct 2007
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic nephropathy
- CKD at stage 1~4
Who cannot join
- Type 1 diabetes or nondiabetic renal disease
- An elevated plasma K level.
About this study
Insulin resistance typically characterizes type 2 diabetes (T2DM) and prediabetic states and is the prominent feature of the metabolic syndrome.Adiponectin plays an important part in glucose metabolism,insulin resistance, the deterioration of renal function.we hypothesize there is a difference serum adiponectin levels between obese and non-obese women with type 2 diabetic nephropathy. Furthermore, these two groups would respond difference to the RAs blocker(Losartan).
Read the detailed description
it would be a prospective cohort study. According to BMI, all the women, aged>30yr, diagnosed type 2 diabetic nephropathy, chronic kidney disease stage range from 1 to 4, will be divided to two group. Renal function index(included SCr, GFR, et al),glucose metabolism index( fasting glucose, plasma insulin et al),and adiponectin concentration will be observed and recorded. both two groups females will accept the treatment of RAS blocker(losartan, 100mg daily, 6 month). during the study, the above mentioned parameters will also be recorded 3 month intervals. Meanwhile, any side effects would be pay attention.
- Conditions
- Obese, Type 2 Diabetes, Diabetic Nephropathy, Glucose Metabolism, Angiotensin II Type 1 Receptor Blockers
- Being tested
- losartan
- Keywords
- obese female, Type 2 Diabetes, Diabetic Nephropathy, Glucose Metabolism, Angiotensin II Type 1 Receptor Blockers, Adiponectin
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
losartanDrug
losartan, 100mg daily,
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR, HbA1c and the adiponectin concentration.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startApr 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- hui min Jin, MD, Principal investigator, shanghai No 3 people's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561704
- Sponsor's protocol ID
- ADL
- Status last verified
- Nov 2007
- First submitted
- 20 Nov 2007
- Last updated
- 21 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiponectin in Obese Women With T2DN and Effects by RAS Blocker
- ClinicalTrials.gov ID
- NCT00561704
- Acronym / sponsor ID
- ADL
- Conditions
- Obese, Type 2 Diabetes, Diabetic Nephropathy, Glucose Metabolism, Angiotensin II Type 1 Receptor Blockers
- Keywords
- obese female, Type 2 Diabetes, Diabetic Nephropathy, Glucose Metabolism, Angiotensin II Type 1 Receptor Blockers, Adiponectin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 21 Nov 2007 (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.
Insulin resistance typically characterizes type 2 diabetes (T2DM) and prediabetic states and is the prominent feature of the metabolic syndrome.Adiponectin plays an important part in glucose metabolism,insulin resistance, the deterioration of renal function.we hypothesize there is a difference serum adiponectin levels between obese and non-obese women with type 2 diabetic nephropathy. Furthermore, these two groups would respond difference to the RAs blocker(Losartan).
Detailed description
it would be a prospective cohort study. According to BMI, all the women, aged>30yr, diagnosed type 2 diabetic nephropathy, chronic kidney disease stage range from 1 to 4, will be divided to two group. Renal function index(included SCr, GFR, et al),glucose metabolism index( fasting glucose, plasma insulin et al),and adiponectin concentration will be observed and recorded. both two groups females will accept the treatment of RAS blocker(losartan, 100mg daily, 6 month). during the study, the above mentioned parameters will also be recorded 3 month intervals. Meanwhile, any side effects would be pay attention.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetic nephropathy
- CKD at stage 1~4
Key exclusion criteria (2 listed)
- Type 1 diabetes or nondiabetic renal disease
- An elevated plasma K level.
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 |
|---|---|---|
| losartanlosartan, 100mg daily, | Drug | – |
Primary outcome
GFR, HbA1c and the adiponectin concentration.
Time frame: 6 month
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 21 Nov 2007.
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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.
hui min Jin, MD principal investigator
shanghai No 3 people's hospital
Questions about this trial
What is this clinical trial studying?
A study testing losartan in people with Obese and Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine.
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 21 Nov 2007. 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?
GFR, HbA1c and the adiponectin concentration. (time frame: 6 month). 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 21 Nov 2007.