Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01509001
Status:
COMPLETED
Last Update Posted:
2012-01-16
First Post:
2012-01-09
Brief Title:
Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2012-01
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:
Aim
The purpose of this study is to compare the effects of glimepirideG and metforminM on vascular reactivity haemostatic factors and glucose and lipid profile in patients with type 2 diabetes
Methods
A prospective study will be performed in 20 uncontrolled patients previously treated with dietary intervention Participants will randomized into M 750 to 2500 mgday or G 1 to 8 mgday therapy After 4 months the patients will be crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule
The following variables were assessed before basal values and after 4 months of each treatment period
1 Hormonal and metabolic determinations fasting plasma glucose insulin catecholamine lipid profile and HbA1 levels
2 Haemostatic factors t-PA antigen and activity PAI-1 antigen and activity platelet aggregation fibrinogen and plasminogen levels
3 Cardiovascular evaluation flow indexes of carotid and brachial arteries Also at the end of each treatment period a 12-hour metabolic profile including measurements of glucose insulin glucagon proinsulin and triglycerides levels at fasting and every 2 hours 700 am to 700 pmwill be done
The purpose of this study is to compare the effects of glimepirideG and metforminM on vascular reactivity haemostatic factors and glucose and lipid profile in patients with type 2 diabetes
Methods
A prospective study will be performed in 20 uncontrolled patients previously treated with dietary intervention Participants will randomized into M 750 to 2500 mgday or G 1 to 8 mgday therapy After 4 months the patients will be crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule
The following variables were assessed before basal values and after 4 months of each treatment period
1 Hormonal and metabolic determinations fasting plasma glucose insulin catecholamine lipid profile and HbA1 levels
2 Haemostatic factors t-PA antigen and activity PAI-1 antigen and activity platelet aggregation fibrinogen and plasminogen levels
3 Cardiovascular evaluation flow indexes of carotid and brachial arteries Also at the end of each treatment period a 12-hour metabolic profile including measurements of glucose insulin glucagon proinsulin and triglycerides levels at fasting and every 2 hours 700 am to 700 pmwill be done
Detailed Description:
Measurements were be made at fasting
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CUNHAMR | OTHER | University of Sao Paulo | None |