The Effects of Metformin on Blood Vessel Structure and Function

Obesity Clinical Trial

Official title:

The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105066
• Other study ID #: AG0017
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2005
• Last updated: January 12, 2017
• Start date: January 2004
• Est. completion date: May 2008

Study information

• Verified date: January 2017
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperglycemia
• Hypertension
• Obesity

Intervention

Drug:
• Metformin
850mg tablet once a day for one month, then twice a day for 3 months
• Placebo
placebo tablet once a day for one month, then twice a day for 3 months

Locations

Country	Name	City	State
United States	National Institute on Aging (NIA), Harbor Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Beisswenger PJ, Howell SK, Touchette AD, Lal S, Szwergold BS. Metformin reduces systemic methylglyoxal levels in type 2 diabetes. Diabetes. 1999 Jan;48(1):198-202. — View Citation

Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65. Erratum in: Lancet 1998 Nov 7;352(9139):1558. — View Citation

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group.. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. — View Citation

Mather KJ, Verma S, Anderson TJ. Improved endothelial function with metformin in type 2 diabetes mellitus. J Am Coll Cardiol. 2001 Apr;37(5):1344-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Arterial Stiffness Compared to Baseline		Baseline and 4.5 months
Primary	Change in Flow Mediated Dilation (FMD)	to evaluate improvement in endothelial function	Baseline and 4.5 months