Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome (EJB044)
Primary Purpose
Metabolic Syndrome, Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebos
metformin
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
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 <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
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Metformin
Arm Description
12 weeks of Placebo tablet 3 x daily
12 weeks of Metformin tablet 850 mg 3 x daily
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02633488
First Posted
September 26, 2014
Last Updated
March 9, 2020
Sponsor
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT02633488
Brief Title
Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome
Acronym
EJB044
Official Title
Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
12 weeks of Placebo tablet 3 x daily
Arm Title
Metformin
Arm Type
Experimental
Arm Description
12 weeks of Metformin tablet 850 mg 3 x daily
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
inactive substance
Intervention Description
A 12 week single blind placebos
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
glucophage
Intervention Description
A 12 week single blind metformin
Primary Outcome Measure Information:
Title
Flow Mediated Dilation - Endothelial Function
Description
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
Time Frame
before and after 12 weeks on placebo or metformin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 <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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Barett, MD, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
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Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome
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