Back to resultsAdiponectin in Obese Women With T2DN and Effects by RAS Blocker
Primary Purpose
Obese, Type 2 Diabetes, Diabetic Nephropathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
losartan
Sponsored by
About this trial
This is an interventional treatment trial for Obese focused on measuring obese female, Type 2 Diabetes, Diabetic Nephropathy, Glucose Metabolism, Angiotensin II Type 1 Receptor Blockers, Adiponectin
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
GFR, HbA1c and the adiponectin concentration.
Secondary Outcome Measures
Full Information
NCT ID
NCT00561704
First Posted
November 20, 2007
Last Updated
November 20, 2007
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00561704
Brief Title
Adiponectin in Obese Women With T2DN and Effects by RAS Blocker
Official Title
Adiponectin in Obese Women With T2DN and Effects by RAS Blocker
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
losartan
Intervention Description
losartan, 100mg daily,
Primary Outcome Measure Information:
Title
GFR, HbA1c and the adiponectin concentration.
Time Frame
6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hui min Jin, MD
Organizational Affiliation
shanghai No 3 people's hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Adiponectin in Obese Women With T2DN and Effects by RAS Blocker
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