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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 12 weeks of Placebo tablet 3 x daily |
|
| Metformin | Experimental | 12 weeks of Metformin tablet 850 mg 3 x daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebos | Drug | A 12 week single blind placebos |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
Subject may participate if on the following drugs, provided the drugs can remain at stable doses throughout the 12 week treatment interval.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Barett, MD, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20228401 | Background | ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14. | |
| 20404853 |
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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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6 subjects failed the screening. 2 subjects voluntarily withdrew.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then Metformin | 12 weeks of Placebo tablet 3 x daily then 8 week washout then 12 weeks of metformin 500 mg 3x daily |
| FG001 | Metformin, Then Placebo | 12 weeks of metformin 500 mg tablet 3 x daily then 8 week washout then 12 weeks of placebo 3x daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, Then Metformin | 12 weeks of Placebo tablet 3 x daily, then a 8 week washout, then 12 weeks Metformin tablet 3 X daily |
| BG001 | Metformin, Then Placebo | 12 weeks of Metformin tablet 850 mg 3 x daily, then 8 week washout , then 12 weeks Placebo tablet 3X daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | percentage of artery dilation | before and after 12 weeks on placebo or metformin |
|
32 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 12 weeks of Placebo tablet 3 x daily Placebos: A 12 week single blind placebos |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eugene J. Barrett MD PhD | University of Virginia | 434-924-1263 | ejb8x@virginia.edu |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| metformin | Drug | A 12 week single blind metformin |
|
|
| Background |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Metformin | 12 weeks of Metformin tablet 850 mg 3 x daily metformin: A 12 week single blind metformin | 0 | 11 | 0 | 11 | 0 | 11 |
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