ObesityPhase 2NCT00105066
The Effects of Metformin on Blood Vessel Structure and Function
A Phase 2 study testing Metformin in people with Obesity and Hypertension, run by National Institute on Aging (NIA) at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Obesity, Hypertension, Hypercholesterolemia
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Aging (NIA), Harbor Hospital
Baltimore, Maryland, 21225
About this study
Official title: The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial)
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).
Read the 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.
- Conditions
- Obesity, Hypertension, Hypercholesterolemia, Hyperglycemia
- Being tested
- Metformin, Placebo
- Keywords
- Metabolic Syndrome, triglycerides, HDL, LDL, High Blood Pressure, High Cholesterol, High Blood Sugar
- Medical subject headings
- Obesity, Hypertension, Hypercholesterolemia, Hyperglycemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Fortamet®; Glucophage®; Glumetza™; Riomet™
850mg tablet once a day for one month, then twice a day for 3 months
PlaceboDrug
placebo tablet once a day for one month, then twice a day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
| Metformin | Experimental | Metformin 850 mg twice daily Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Arterial Stiffness Compared to Baseline
Measured: Baseline and 4.5 months
Change in Flow Mediated Dilation (FMD)
to evaluate improvement in endothelial function
Measured: Baseline and 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2005 (estimated)
- Study startJan 2004
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Luigi Ferrucci, MD, Principal investigator, National Institute on Aging (NIA)James Strait, M.D., Ph.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105066
- Sponsor's protocol ID
- AG0017
- Status last verified
- Jan 2017
- First submitted
- 3 Mar 2005
- Last updated
- 18 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 11832527Beisswenger 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.
PubMed 9892243Mather 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.
PubMed 11300445Effect 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.
PubMed 9742977
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial)
- ClinicalTrials.gov ID
- NCT00105066
- Acronym / sponsor ID
- AG0017
- Conditions
- Obesity, Hypertension, Hypercholesterolemia, Hyperglycemia
- Keywords
- Metabolic Syndrome, triglycerides, HDL, LDL, High Blood Pressure, High Cholesterol, High Blood Sugar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Jan 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 Mar 2005 (estimated)
- Results
- Posted 18 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo |
| Metformin | Experimental | Drug: MetforminMetformin 850 mg twice daily |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Fortamet®; Glucophage®; Glumetza™; Riomet™850mg tablet once a day for one month, then twice a day for 3 months | Drug | Metformin |
| Placeboplacebo tablet once a day for one month, then twice a day for 3 months | Drug | Placebo |
Primary outcome
Change in Arterial Stiffness Compared to Baseline
Time frame: Baseline and 4.5 months
Change in Flow Mediated Dilation (FMD)
Time frame: Baseline and 4.5 months
to evaluate improvement in endothelial function
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11832527Knowler 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.
- Background: PubMed 9892243Beisswenger 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.
- Background: PubMed 11300445Mather 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.
- Background: PubMed 9742977Effect 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Ferrucci, MD principal investigator
National Institute on Aging (NIA)
James Strait, M.D., Ph.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Obesity and Hypertension, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Arterial Stiffness Compared to Baseline (time frame: Baseline and 4.5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105066, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.