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NCT00561704 Clinical Trial

Adiponectin in Obese Women With T2DN and Effects by RAS Blocker

Type 2 Diabetes Clinical Trial

Official title:
Adiponectin in Obese Women With T2DN and Effects by RAS Blocker

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00561704
Other study ID # ADL
Secondary ID
Status Completed
Phase N/A
First received November 20, 2007
Last updated November 20, 2007
Start date April 2007
Est. completion date October 2007

Study information
Verified date November 2007
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical 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 between obese and non-obese women with type 2 diabetic nephropathy. Furthermore, these two groups would respond difference to the RAs blocker(Losartan).

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 30 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• losartan
losartan, 100mg daily,

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome
Type Measure Description Time frame Safety issue
Primary GFR, HbA1c and the adiponectin concentration. 6 month
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