Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501488
Status:
COMPLETED
Last Update Posted:
2007-07-20
First Post:
2007-07-13
Brief Title:
Effect of Adiponectin Genetic Polymorphism on Rosiglitazone Response
Sponsor:
Central South University
Organization:
Central South University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 -11377CG or 45TG genotypes were selected to administrate orally 4mg rosiglitazone daily for 12 consecutive weeks
A total of 255 T2D patients and 120 health volunteers were enrolled in this study 42 T2D patients with -11377CG or 45TG 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 45TG and -11377CG 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 486 107 years and 120 healthy controls 53 females 67 males aged from 25 to 70 yearsmean 471 110 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 70 mmolL andor postprandial plasma glucose test PPG 111 mmolL The inclusion criteria of all subjects were that subjects had the range of body mass index BMI from 185 to 30 kgm2 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
A total of 255 T2D patients 138 males 117 females aged from 25 to 70 years mean 486 107 years and 120 healthy controls 53 females 67 males aged from 25 to 70 yearsmean 471 110 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 70 mmolL andor postprandial plasma glucose test PPG 111 mmolL The inclusion criteria of all subjects were that subjects had the range of body mass index BMI from 185 to 30 kgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None