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The Effects of Metformin on Blood Vessel Structure and Function

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ClinicalTrials.gov Identifier: NCT00105066
Recruitment Status : Completed
First Posted : March 4, 2005
Results First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on the blood vessels of individuals with the Metabolic Syndrome (MeS).

Condition or disease Intervention/treatment Phase
Obesity Hypertension Hypercholesterolemia Hyperglycemia Drug: Metformin Drug: Placebo Phase 2

Detailed Description:

Individuals with the Metabolic Syndrome (MeS) are at increased risk for developing cardiovascular diseases. This increased risk may, in part, be related to abnormalities in the blood vessels. MeS is defined as having 3 or more of the following 5 criteria:

  • Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women)
  • Elevated triglycerides (>150 mg/dl)
  • Low HDL or "good" cholesterol (<40 mg/dl in men or <50 mg/dl in women)
  • Elevated blood pressure (>130/85) or treatment for high blood pressure
  • Elevated fasting blood sugar (>100 mg/dl)

Metformin is a medication that is approved by the Food and Drug Administration (FDA) for the treatment of diabetes; however, it can also be safely administered to non-diabetic subjects. We are evaluating whether Metformin reduces the stiffness of blood vessels and improves endothelial function.

This study requires 4 visits to the NIA Clinical Research Center (located on the premises of Harbor Hospital) over a 5-month period. At the initial visit, patients will be given a physical examination with blood and urine tests, and an EKG. They will be randomized into one of two groups; one group will receive Metformin (1700 mg per day), while the other group will receive a placebo. Participants will take the medication for 4 months. Subsequent visits will include additional blood tests, ultrasound and echo exams.

Taking part in this study is entirely voluntary. All testing and medications will be provided at no cost to the participant or their family.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial)
Study Start Date : January 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
placebo
 Drug: Placebo
placebo tablet once a day for one month, then twice a day for 3 months
Experimental: Metformin
Metformin 850 mg twice daily
 Drug: Metformin
850mg tablet once a day for one month, then twice a day for 3 months
Other Name: Fortamet®; Glucophage®; Glumetza™; Riomet™


Outcome Measures
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Primary Outcome Measures :
  1. Change in Arterial Stiffness Compared to Baseline [ Time Frame: Baseline and 4.5 months ]
  2. Change in Flow Mediated Dilation (FMD) [ Time Frame: Baseline and 4.5 months ]
    to evaluate improvement in endothelial function


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants with the Metabolic Syndrome, which is defined as having 3 or more of the following 5 alterations:

  • Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women)
  • Elevated triglycerides (>150 mg/dl)
  • Low HDL or "good" cholesterol (<40 mg/dl in men or <50 mg/dl in women)
  • Elevated blood pressure (>130/85) or treatment for high blood pressure
  • Elevated fasting blood sugar (>100 mg/dl)

Exclusion Criteria:

  • Diabetes treated with medication
  • Blood pressure >160/100 mmHg
  • Clinical Congestive Heart Failure
  • Anemia with hematocrit <32%
  • Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring daily medication or use of home oxygen therapy
  • Major surgery planned within the next six months
  • A recent, unexplained weight loss of >10% of body weight in the past 6 months
  • A known allergy or hypersensitivity to Metformin
  • History of hepatitis or cirrhosis
  • History of kidney disease (defined as serum creatinine >1.4 mg/dL in men, >1.3 mg/dL in women)
  • Pregnancy or the absence of an effective method of contraception
  • Illicit drug or alcohol abuse
  • Cancer requiring treatment currently or recently completed treatment in the last 2 months
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105066


Locations
United States, Maryland
National Institute on Aging (NIA), Harbor Hospital
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Luigi Ferrucci, MD National Institute on Aging (NIA)
Principal Investigator: James Strait, M.D., Ph.D. National Institute on Aging (NIA)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00105066     History of Changes
Other Study ID Numbers: AG0017
First Posted: March 4, 2005    Key Record Dates
Results First Posted: January 18, 2017
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ):
Metabolic Syndrome
triglycerides
HDL
LDL
 High Blood Pressure
High Cholesterol
High Blood Sugar

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperglycemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Glucose Metabolism Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs