The Effects of Metformin on Blood Vessel Structure and Function

NCT00105066 | Completed Phase 2 Results

• 1 other identifier: AG0017
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Hypertension; Hypercholesterolemia; Hyperglycemia

Keywords

Metabolic Syndrome; triglycerides; HDL; LDL; High Blood Pressure; High Cholesterol; High Blood Sugar

Outcome Measures

Primary Outcomes (2)

• Change in Arterial Stiffness Compared to Baseline

  Baseline and 4.5 months

• Change in Flow Mediated Dilation (FMD)

  to evaluate improvement in endothelial function

  Baseline and 4.5 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Metformin

EXPERIMENTAL

Metformin 850 mg twice daily

Drug: Metformin

Interventions

Metformin DRUG

850mg tablet once a day for one month, then twice a day for 3 months

Also known as: Fortamet®; Glucophage®; Glumetza™; Riomet™

Metformin

Placebo DRUG

placebo tablet once a day for one month, then twice a day for 3 months

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute on Aging (NIA), Harbor Hospital

Baltimore, Maryland, 21225, United States

Location

Related Publications (4)

• 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. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

• 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. doi: 10.2337/diabetes.48.1.198.

  PMID: 9892243 BACKGROUND

• 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. doi: 10.1016/s0735-1097(01)01129-9.

  PMID: 11300445 BACKGROUND

• 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.

  PMID: 9742977 BACKGROUND

MeSH Terms

Conditions

Obesity; Hypertension; Hypercholesterolemia; Hyperglycemia; Metabolic Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr. James Strait
• Organization: National Institute On Aging

straitj@mail.nih.gov

4105588084

Study Officials

• Luigi Ferrucci, MD

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

• James Strait, M.D., Ph.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: January 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 18, 2017
• Results First Posted: January 18, 2017

Record last verified: 2017-01

Locations

US (1)