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

NCT ID: NCT02633488

Last Updated: 2020-03-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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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) Placebos and 2) Metformin . This is a cross-over design.

Conditions

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Metabolic Syndrome Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

12 weeks of Placebo tablet 3 x daily

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

A 12 week single blind placebos

Metformin

12 weeks of Metformin tablet 850 mg 3 x daily

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

A 12 week single blind metformin

Interventions

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Placebos

A 12 week single blind placebos

Intervention Type DRUG

metformin

A 12 week single blind metformin

Intervention Type DRUG

Other Intervention Names

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inactive substance glucophage

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Eugene Barrett

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugene Barett, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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Other Identifiers

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16121

Identifier Type: -

Identifier Source: org_study_id

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