Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105066
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2005-03-03
Brief Title:
The Effects of Metformin on Blood Vessel Structure and Function
Sponsor:
National Institute on Aging NIA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome MET Trial
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on the blood vessels of individuals with the Metabolic Syndrome MeS
Detailed Description:
Individuals with the Metabolic Syndrome MeS are at increased risk for developing cardiovascular diseases This increased risk may in part be related to abnormalities in the blood vessels MeS is defined as having 3 or more of the following 5 criteria
Abdominal obesity waist measurement 398 inches in men 344 inches in women
Elevated triglycerides 150 mgdl
Low HDL or good cholesterol 40 mgdl in men or 50 mgdl in women
Elevated blood pressure 13085 or treatment for high blood pressure
Elevated fasting blood sugar 100 mgdl
Metformin is a medication that is approved by the Food and Drug Administration FDA for the treatment of diabetes however it can also be safely administered to non-diabetic subjects We are evaluating whether Metformin reduces the stiffness of blood vessels and improves endothelial function
This study requires 4 visits to the NIA Clinical Research Center located on the premises of Harbor Hospital over a 5-month period At the initial visit patients will be given a physical examination with blood and urine tests and an EKG They will be randomized into one of two groups one group will receive Metformin 1700 mg per day while the other group will receive a placebo Participants will take the medication for 4 months Subsequent visits will include additional blood tests ultrasound and echo exams
Taking part in this study is entirely voluntary All testing and medications will be provided at no cost to the participant or their family
Abdominal obesity waist measurement 398 inches in men 344 inches in women
Elevated triglycerides 150 mgdl
Low HDL or good cholesterol 40 mgdl in men or 50 mgdl in women
Elevated blood pressure 13085 or treatment for high blood pressure
Elevated fasting blood sugar 100 mgdl
Metformin is a medication that is approved by the Food and Drug Administration FDA for the treatment of diabetes however it can also be safely administered to non-diabetic subjects We are evaluating whether Metformin reduces the stiffness of blood vessels and improves endothelial function
This study requires 4 visits to the NIA Clinical Research Center located on the premises of Harbor Hospital over a 5-month period At the initial visit patients will be given a physical examination with blood and urine tests and an EKG They will be randomized into one of two groups one group will receive Metformin 1700 mg per day while the other group will receive a placebo Participants will take the medication for 4 months Subsequent visits will include additional blood tests ultrasound and echo exams
Taking part in this study is entirely voluntary All testing and medications will be provided at no cost to the participant or their family
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