Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome (EJB044)

March 9, 2020 updated by: Eugene Barrett, University of Virginia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
12 weeks of Placebo tablet 3 x daily
Drug: Placebos
A 12 week single blind placebos
Other Names:
  • inactive substance
Experimental: Metformin
12 weeks of Metformin tablet 850 mg 3 x daily
Drug: metformin
A 12 week single blind metformin
Other Names:
  • glucophage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow Mediated Dilation - Endothelial Function
Time Frame: before and after 12 weeks on placebo or metformin
brachial artery ultrasonography % flow-mediated dilatation (FMD) for assessing endothelial function before and after an insulin clamp to assess insulin's effect on the vasculature
before and after 12 weeks on placebo or metformin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Eugene Barett, MD, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be reported as composite for the entire population. In some figures individual data point are displayed but not identified with individual subjects.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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