Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome

Completed · Not applicable · Has a placebo group

Conditions studied: Metabolic Syndrome, Insulin Sensitivity

In brief

The purpose of this study is to look at how insulin (a hormone that helps the cells get energy from sugar) in our body affects blood vessels (elasticity in the bigger blood vessels and blood flow in the smaller blood vessels in the arm) and how Metformin (a drug that makes you more sensitive to insulin) affects insulin's action on the blood vessels.

Key facts

Study ID

NCT02633488

Run by

University of Virginia

People needed

19

Starts

2014-06-01

Expected to finish

2016-07-01

Last updated by the study team

2020-03-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-60
• No smoking the past 6 months
• Normal screening labs or no clinically significant values-except those listed below
• Must have 3 of the following 4 characteristics established by NCEP-AHA-NHLBI
• Males waist circumference greater than 40 inches, females greater than 35 inches
• Blood pressure greater than 130/85 or on treatment with one or more antihypertensive agent
• Fasting plasma triglycerides >150 or HDL <40 (males) <50 (females)
• Fasting blood sugar >100 but <126
• Subject may participate if on the following drugs, provided the drugs can remain at stable doses throughout the 12 week treatment interval.
• Ace inhibitor
• ARB
• HMG CoA reductase inhibitor
• Beta blocker
• Calcium channel blockers
• Alpha-adrenergic antagonist

You may not qualify if…

• Smoking presently or in the past 6 months
• HbA1c ≥ 6.5
• Glucocorticoids-eg: prednisone, dexamethasone
• Any known sensitivity or intolerance to Metformin
• Any chronic GI disorders such as Irritable Bowel Syndrome or Crohns disease
• History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease.
• History of malignant or metabolic disorders including diabetes
• Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI)
• Hypersensitivity to perflutren (contained in Definity)
• Pregnant or breastfeeding

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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