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Sponsored by: |
Central South University |
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Information provided by: | Central South University |
ClinicalTrials.gov Identifier: | NCT00501488 |
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.
Condition | Intervention |
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Diabetes Mellitus |
Drug: rosiglitazone |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Enrollment: | 42 |
Study Start Date: | March 2006 |
Study Completion Date: | February 2007 |
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.
Ages Eligible for Study: | 25 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
China, Hunan | |
Central South University | |
Changsha, Hunan, China, 410078 |
Principal Investigator: | Zhao-Qian Liu, MD, Ph.D | Central South University Xiangya School of Medicine |
Study ID Numbers: | Zhao-Qian Liu |
Study First Received: | July 13, 2007 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00501488 |
Health Authority: | China: Ethics Committee |
pharmacodynamics insulin resistance therapy volunteer |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Endocrinopathy Insulin Resistance |
Metabolic disorder Glucose Metabolism Disorders Rosiglitazone Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |