N/A Completed N=11 Randomized Single-blind Treatment

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

Metabolic Syndrome · Insulin Sensitivity

Source: ClinicalTrials.gov NCT02633488 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcomePrimary: Flow Mediated Dilation - Endothelial Function — 6.1; 6.2 percentage of artery dilation — p=>0.05

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Flow Mediated Dilation - Endothelial Function	6.1; 6.2	>0.05

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02633488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.