Effect of Adiponectin Genetic Polymorphism on Rosiglitazone Response

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501488
• Other study ID #: Zhao-Qian Liu
• Status: Completed
• Phase: N/A
• First received: July 13, 2007
• Last updated: July 19, 2007
• Start date: March 2006
• Est. completion date: February 2007

Study information

• Verified date: July 2007
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aims of the present study were to investigate the association between adiponectin gene polymorphisms and the response to rosiglitazone monotherapy in T2D patients.

A total of 255 T2D patients and 120 health volunteers were enrolled in this study. 42 T2D patients with -11377(C/G) or +45(T/G) genotypes were selected to administrate orally 4mg rosiglitazone daily for 12 consecutive weeks.

Description:

The aims of the present study were to investigate the association between adiponectin allele +45(T/G) and -11377(C/G) polymorphisms and the response to rosiglitazone monotherapy in T2D patients.

A total of 255 T2D patients (138 males, 117 females) aged from 25 to 70 years (mean 48.6 ± 10.7 years) and 120 healthy controls (53 females, 67 males) aged from 25 to 70 years(mean 47.1 ± 11.0 years) were enrolled to participate in this study. Physical examination, medical history and serum biochemical tests were performed to identify healthy or T2D subjects. The diagnosis criteria of T2D patients were made according to the World Health Organization in 1997 by fasting plasma glucose (FPG  7.0 mmol/L) and/or postprandial plasma glucose test (PPG  11.1 mmol/L). The inclusion criteria of all subjects were that subjects had the range of body mass index (BMI) from 18.5 to 30 kg/m2 and did not administrate any PPAR agonists in the last 3 months. Patients who were receiving insulin treatment, pregnant or lactating women, or with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, and kidney disease or liver disease were excluded from this study. Table 1 showed the characteristic profiles of T2D patients and healthy controls. There were no statistical differences in the age, height, weight, and BMI value between T2D patients and healthy controls. All subjects were recruited from local residents in Changsha city, Hunan Province, P. R. China. The study protocol was approved by the Ethics Committee of Xiangya School of Medicine, Central South University and written informed consents were obtained before the start of this study. A total of 42 T2D patients (23 male, 19 female) were randomly selected to be only treated with 4mg rosiglitazone daily for 12 consecutive weeks without change in previous medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• The diagnosis criteria of T2D patients were made according to the World Health Organization in 1997 by fasting plasma glucose (FPG ? 7.0 mmol/L) and/or postprandial plasma glucose test (PPG ? 11.1 mmol/L)

• The inclusion criteria of all subjects were that subjects had the range of body mass index (BMI) from 18.5 to 30 kg/square meter and did not administrate any PPAR agonists in the last 3 months.

Exclusion Criteria:

• Patients who were receiving insulin treatment, pregnant or lactating women, or with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, and kidney disease or liver disease were excluded from this study.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• rosiglitazone

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

External Links

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