Effect of Adiponectin Genetic Polymorphism on Rosiglitazone Response

NCT ID: NCT00501488

Last Updated: 2007-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-02-28

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: DEFINED_POPULATION
• Study Time Perspective: PROSPECTIVE

Interventions

rosiglitazone

Intervention Type: DRUG

Eligibility Criteria

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)

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central South University

OTHER

Sponsor Role: lead

Principal Investigators

Zhao-Qian Liu, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Central South University Xiangya School of Medicine

Locations

Central South University

Changsha, Hunan, China

Countries

China

Related Links

http://www.csupharmacol.com

Related Info

Other Identifiers

Zhao-Qian Liu

Identifier Type: -

Identifier Source: org_study_id