Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors in Obese Adolescents - NCT00858247-55905 (Clinical Trial 276776)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy276776.aspx
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| City: |
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Rochester |
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State:
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MN |
| Zip Code: |
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55905 |
| Conditions: |
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Obesity |
| Purpose: |
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The prevalence of obesity has reached epidemic proportions nationally as well as
internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a
risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to
vitamin D insufficient. In adults, low vitamin D status appears to be associated with the
development of type 2 diabetes and metabolic syndrome. There is little information on the
prevalence of vitamin D insufficiency and its implications in obese adolescents.
Additionally, it is unknown whether treatment of vitamin D insufficiency in adolescents
might result in improvement in insulin resistance, lipids and cardiovascular risk markers.
We hypothesize that vitamin D insufficiency correlates positively with insulin resistance
and cardiovascular risk in obese adolescents and that vitamin D3 supplementation improves
insulin resistance and cardiovascular risk factors in this population. The purpose of the
study is to determine the impact of vitamin D3 supplementation on various parameters of
insulin secretion, insulin action, lipids and C-reactive protein in obese adolescents.
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| Study summary: |
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The problem of childhood obesity has reached epidemic proportions both nationally and
internationally. The prevalence of obesity has tripled in the last three decades and
currently 16 % of American adolescents are obese. Nearly 30% of obese adolescents
demonstrate a metabolic syndrome characterized by insulin resistance and dyslipidemia. These
abnormalities lead to the development of type 2 diabetes mellitus and to increased
cardiovascular morbidity and mortality. Obesity is a well-known risk factor for vitamin D
insufficiency and up to 80% of obese adults have been found to be insufficient in vitamin D.
Observational studies in adults have shown consistent associations between low vitamin D
status and prevalence of type 2 diabetes mellitus and metabolic syndrome. There is paucity
of data on the prevalence of vitamin D insufficiency and its implications in obese
adolescents. It is also not known whether treatment of vitamin D insufficiency in children
or adults might result in improvement in insulin resistance and cardiovascular risk factors.
Hypotheses: We hypothesize that vitamin D insufficiency correlates positively with insulin
resistance and cardiovascular risk in obese adolescents and that vitamin D3 supplementation
decreases insulin resistance and cardiovascular risk factors in this population.
Objectives:
1. Determine if there is any correlation between serum 25(OH)D levels and HOMA-IR, HDL
cholesterol and C-reactive protein, in obese adolescents.
2. Study the impact of vitamin D3 supplementation on various parameters reflecting insulin
action, secretion, lipids and C-reactive protein in obese adolescents. |
| Criteria: |
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Inclusion Criteria:
1. Age between 12-18 years
2. BMI is at or greater than the 95th percentile for age and gender
Exclusion Criteria:
1. Subjects with 25 (OH)- D levels >100 ng/mL
2. Serum calcium >10.8 mg/dL
3. Current cancer
4. Those taking a multivitamin supplementation
5. Hepatic or renal disorders
6. Type 1 or type 2 diabetes mellitus.
7. Those receiving insulin, metformin or oral hypoglycemic medications
- Use of glucocorticoids and anti-seizure medications in the previous 6 months
- Malabsorption syndromes such as celiac disease |
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| Study is available at: |
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Mayo Clinic
Rochester, MN 55905
United States
Primary Contact:
Seema Kumar, M.D.
Email: kumar.seema@mayo.edu
Phone: 507-284-3300 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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