- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00561704
Adiponectin in Obese Women With T2DN and Effects by RAS Blocker
November 20, 2007 updated by: Shanghai Jiao Tong University School of Medicine
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Type 2 diabetic nephropathy
- CKD at stage 1~4
Exclusion Criteria:
- Type 1 diabetes or nondiabetic renal disease
- An elevated plasma K level.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GFR, HbA1c and the adiponectin concentration.
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: hui min Jin, MD, shanghai No 3 people's hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
November 20, 2007
First Submitted That Met QC Criteria
November 20, 2007
First Posted (Estimate)
November 21, 2007
Study Record Updates
Last Update Posted (Estimate)
November 21, 2007
Last Update Submitted That Met QC Criteria
November 20, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Urologic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Kidney Diseases
- Diabetic Nephropathies
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Losartan
Other Study ID Numbers
- ADL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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