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

NCT02633488 | Completed Results

• 1 other identifier: 16121
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome; Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Dilation - Endothelial Function

  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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

12 weeks of Placebo tablet 3 x daily

Drug: Placebos

Metformin

EXPERIMENTAL

12 weeks of Metformin tablet 850 mg 3 x daily

Drug: metformin

Interventions

Placebos DRUG

A 12 week single blind placebos

Also known as: inactive substance

Placebo

metformin DRUG

A 12 week single blind metformin

Also known as: glucophage

Metformin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

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MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Eugene J. Barrett MD PhD
• Organization: University of Virginia

ejb8x@virginia.edu

434-924-1263

Study Officials

• Eugene Barett, MD, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: December 17, 2015
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)