Completed

Oral Glucosamine Impact on Insulin Sensitivity and Capillary Recruitment in Normal and Obese Individuals

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What is being tested

Data Collection

Who is being recruted

Arthritis+16

+ Body Weight

+ Diabetes Mellitus

From 21 to 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2003
See protocol details

Summary

Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2003

Actual date on which the first participant was enrolled.

This study explores the effects of Glucosamine, a popular nutritional supplement used for treating osteoarthritis, on insulin sensitivity and capillary recruitment in both normal and obese individuals. While intravenous glucosamine has been found to cause insulin resistance and vascular endothelial dysfunction, the potential effects of oral glucosamine on these factors remain unexplored. This research is crucial as insulin resistance and vascular dysfunction contribute significantly to major public health issues like diabetes, obesity, hypertension, and cardiovascular diseases. The study involves normal healthy volunteers and obese insulin-resistant subjects. Participants will take part in a randomized double-blind, placebo-controlled, crossover study. They will receive either a placebo or oral glucosamine (500 mg three times a day for 6 weeks). The study will use the reference standard hyperinsulinemic isoglycemic glucose clamp technique to evaluate insulin sensitivity before treatment, after placebo or glucosamine, and after the crossover. Insulin-stimulated capillary recruitment will also be assessed using the ultrasound microbubble contrast technique. This will help measure blood flow in the brachial artery and capillary recruitment in forearm skeletal muscle in response to hyperinsulinemia. Additionally, plasma glucosamine levels will be measured before each glucose clamp study. The study aims to determine if oral glucosamine worsens insulin resistance and capillary recruitment in obese subjects or causes significant insulin resistance in healthy volunteers.

Official TitleAn Exploratory Study of the Effects of Oral Glucosamine Administration on Insulin Sensitivity and Capillary Recruitment in Normal and Obese Subjects
NCT00065377
Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBody WeightDiabetes MellitusEndocrine System DiseasesHyperinsulinismInsulin ResistanceJoint DiseasesMetabolic DiseasesMusculoskeletal DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesityOsteoarthritisRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

2 inclusion criteria required to participate
Males or females in good general health with no significant underlying illnesses, on no medication, between the ages of 21-65 years of age with HbA1C less than 6.5, fasting blood glucose less than 100 mg/dl, blood pressure less than 130/85, and BMI between 20-26 kg/m(2). Subjects should have never smoked tobacco or not smoked within the previous 2 years.

Males or females in good general health with no significant underlying illnesses, on no medication, between the ages of 21-65 years of age with HbA1C less than 6.5, fasting blood glucose less than 110 mg/dl, blood pressure less than 130/85, and BMI between 30-40 kg/m(2).

5 exclusion criteria prevent from participating
Subjects will be excluded if they have diabetes, hypertension, pregnancy, liver disease, pulmonary disease, renal insufficiency, coronary heart disease, heart failure, peripheral vascular disease, coagulopathy, actively smoking within last two years, in treatment for any form of cancer, positive tests for HIV, hepatitis B or C, or take systemic corticosteroids.

Subjects will be excluded if they have an allergy to shellfish since glucosamine is derived from shellfish.

Subjects will be excluded if they have taken glucosamine within the last three months.

Subjects with allergies to blood products or eggs or known hypersensitivity to albumin will also be excluded from participating because of potential adverse effects from microbubble contrast agent.

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Center for Complementary and Alternative Medicine (NCCAM)

Bethesda, United StatesOpen National Center for Complementary and Alternative Medicine (NCCAM) in Google Maps
CompletedOne Study Center