Effects of Oral Glucosamine on Insulin and Blood Vessel Activity in Normal and Obese People
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|ClinicalTrials.gov Identifier: NCT00065377|
Recruitment Status : Completed
First Posted : July 22, 2003
Last Update Posted : June 26, 2006
This study will examine whether glucosamine affects the way the body responds to insulin. Insulin is a hormone that causes the body to use glucose (sugar). Insulin does not work as well in overweight people, causing a condition called insulin resistance. Insulin also increases the flow of blood into muscle by opening inactive blood vessels. This study will test whether glucosamine, a nutritional supplement that many people take to treat arthritis, can cause or worsen insulin resistance or change how blood vessels react to insulin in normal weight and overweight people.
Healthy normal weight and overweight volunteers between 21 and 65 years of age may be eligible for this study. Candidates will be screened with a brief physical examination, medical history, and blood and urine tests. After screening, participants will have three additional outpatient clinic visits for the following procedures:
- Glucose clamp test to measure the body's response to insulin: For this procedure, a needle is placed in a vein of each arm, one for drawing blood samples, and one for infusing glucose and a potassium solution. The glucose is infused continuously during this 4-hour test and blood is drawn frequently to monitor glucose and insulin levels. After the test, blood glucose levels are monitored for another 2 hours to make sure they remain at an adequate level to prevent hypoglycemia (low blood sugar).
- Blood flow measurement: Blood flow in the brachial artery of the arm is measured to assess how many capillaries (very small blood vessels) are being used to supply nutrients and oxygen to the muscle in the forearm. This test is done at the same time as the glucose clamp test. Blood flow is measured using a technique called contrast ultrasound. A small amount of contrast agent consisting of gas-filled bubbles the size of red blood cells is infused over 10 minutes through one of the catheters placed in the vein for the glucose clamp test. The contrast agent is infused twice, once at the beginning of the glucose clamp test and once at the end of the test. The contrast material creates a signal in response to ultrasound that provides information about the distribution of capillaries in the forearm.
- Assignment to medication group: Participants are randomly assigned to take either glucosamine or placebo three times a day by mouth for 6 weeks. At the end of the 6 weeks, no study drug is taken for 1 week, and then participants "cross-over" medications, those who took glucosamine for the first 6 weeks take placebo for the next 6 weeks and vice versa.
Visits 2 and 3
For these visits, the glucose clamp test and blood flow measurements are repeated. Visit 2 is scheduled at the end of the first 6-week treatment period, and Visit 3 is scheduled at the end of the second 6-week treatment period.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Insulin Resistance||Drug: Glucosamine Hydrochloride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Official Title:||An Exploratory Study of the Effects of Oral Glucosamine Administration on Insulin Sensitivity and Capillary Recruitment in Normal and Obese Subjects|
|Study Start Date :||July 2003|
|Study Completion Date :||June 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065377
|United States, Maryland|
|National Center for Complementary and Alternative Medicine (NCCAM)|
|Bethesda, Maryland, United States, 20892|