- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037660
Effects of Lipemia and Metformin on Endothelial Function
March 8, 2017 updated by: Naomi M Hamburg, Boston University
Eating a diet high in fat contributes to the development of atherosclerosis (hardening of the arteries).
Acute fat consumption increases levels of fat in the blood and temporarily reduces the ability of blood vessel to dilate (open up to carry additional blood).
A similar response is observed during infusion of Intra-Lipid (a fat emulsion used for intravenous nutrition).
The present study is designed to help us understand the effects of a fat load on blood vessel function.
We will measure arterial dilation using non-invasive techniques before and at the end of a 5-hour infusion of Intra-Lipid in healthy subjects.
Subjects will then take the approved drug metformin for two weeks and return for repeat studies of endothelial function with Intra-Lipid infusion.
We expect that metformin will help preserve the normal function of blood vessels during a fat load.
This study will help us understand how fat affects blood vessels and therefore will advance our knowledge of the development of atherosclerosis and potentially lead to improved methods to prevent and treat heart disease.
Study Overview
Study Type
Interventional
Enrollment (Actual)
139
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Pregnancy (defined as positive urine pregnancy test)
- Diabetes Mellitus (Clinical history or random blood glucose>140 mg/dl)
- Hypertension (Clinical history or SBP>140 or DBP>90 mmHg)
- History of adverse reaction to metformin
- Abnormal renal function (Serum creatinine>1.4 mg/dl)
- Abnormal liver function (AST or ALT greater than two times the upper limit of normal)
- Administration of iodinated contrast within 7 days
- History of congestive heart failure
- Abnormal clotting parameters (INR>1.5 or PTT>40 sec)
- Anemia (HCT<30%)
- Allergy to soy or egg
- Allergy to heparin
- The potential subject plans to perform heavy exercise in the setting of low calorie intake during the period of the study such as running or competitive road or bicycle racing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin
|
Metformin 1 gram per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brachial artery flow-mediated dilation
Time Frame: 6 hours
|
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood lipid levels
Time Frame: 6 hours
|
6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2005
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
December 19, 2009
First Submitted That Met QC Criteria
December 21, 2009
First Posted (Estimate)
December 23, 2009
Study Record Updates
Last Update Posted (Actual)
March 10, 2017
Last Update Submitted That Met QC Criteria
March 8, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-23660
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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