Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Endocrine, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | June 2019 |
| Contact: | Linda Jahn, RN, MEd |
| Email: | las6e@virginia.edu |
| Phone: | 434-924-1134 |
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.
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.
In our protocol, we will study vascular function using pulse wave velocity (PWV)
augmentation index (AI), flow mediated dilation (FMD) and contrast enhanced ultrasound (CEU)
as well as insulin sensitivity (euglycemic clamp) in 50 adults with metabolic syndrome, age
18-60 years. They will each be studied 4 times,before and after two 12-wk interventions
(randomly assigned) as follows: 1) Placebo and 2) Metformin . This is a cross-over design.
augmentation index (AI), flow mediated dilation (FMD) and contrast enhanced ultrasound (CEU)
as well as insulin sensitivity (euglycemic clamp) in 50 adults with metabolic syndrome, age
18-60 years. They will each be studied 4 times,before and after two 12-wk interventions
(randomly assigned) as follows: 1) Placebo and 2) Metformin . This is a cross-over design.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Eugene J Barrett, MD
Phone: 434-924-1134
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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