Vitamin D Retrospective Study
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Purpose
Vitamin D deficiency is associated with a heightened risk for developing type 2 diabetes, hypertension, and osteopenia/osteoporosis. Vitamin D is made in the skin when it is exposed to sunlight and it is also obtained from the diet and dietary supplements. Older people, individuals with high skin pigmentation, obese and sedentary individuals have low levels of Vitamin D because pigmentation blocks Vitamin D production in the skin, aging and physical inactivity are associated with reduced exposure to sunlight, and obesity is associated with the storage of Vitamin D in fat preventing its utilization by muscle, bone and other tissues that require its metabolic action. These conditions are also associated with heightened risk for developing type 2 diabetes, glucose intolerance, hypertension, and osteopenia/osteoporosis in older and obese individuals. This is particularly heightened in older women who tend to have increased body fat, are more physically inactive and are at high risk for central obesity and its metabolic consequences of diabetes, hypertension and osteoporosis.
The heightened prevalence of obesity in aging especially in postmenopausal women suggests that interventions to raise Vitamin D levels might be preventive of these diseases. Investigators have completed studies of the effects of weight loss and exercise interventions in approximately 400 older women and men over the last 15 years, many of whom are obese. Investigators have data on glucose tolerance, blood pressure and bone density in these studies and stored plasma in which investigators can analyze Vitamin D levels. Vitamin D may be an important risk factor for these metabolic diseases and the availability of these samples for Vitamin D analysis will allow investigators to perform a cross-sectional study to address relationships of Vitamin D levels to glucose intolerance and diabetes, hypertension/blood pressure status, bone mineral density, the degree of obesity, and physical activity status measured as maximal aerobic capacity and accelerometry in these older men and women.
The results of this study have the potential to impact clinical practice in the prevention and treatment of diabetes, hypertension, and osteopenia/osteoporosis. This would circumvent the current dilemma for prevention of these chronic diseases through treatment of obesity, as these data would provide immediate prospects for changing the recommended doses of Vitamin D beneficial for reducing risk for these diseases.
The purpose of this study is to 1) determine the prevalence of Vitamin D deficiency in obese, older men and postmenopausal women and 2) the association of Vitamin D levels to glucose tolerance, blood pressure, bone mineral density, and hyperlipidemia, as well as association with Vitamin D receptor gene polymorphisms affecting metabolic responses to Vitamin D.
| Condition | Intervention |
|---|---|
|
Vitamin D Status Glucose Tolerance Blood Pressure Bone Mineral Density Hyperlipidemia |
Other: Vitamin D |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Association of Vitamin D With Diabetes, Osteoporosis and Cardiovascular Risk |
- Vitamin D [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Vitamin D level ng/dl
- IGF-1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Insulin like growth factor
- IGF binding proteins [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Insulin Growth Factor Binding protein levels
- PTH [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Parathyroid Hormone levels
Biospecimen Retention: Samples With DNA
Vitamin D, IGF-1, and PTH levels will be measured in coded plasma samples belonging to the PI and collaborating Investigators within the GRECC that are stored in our freezers (from previously approved studies: HP-00040261,HP-00040975, HP-00041166 and HP-00041199) . The Nutrition Obesity research center genetics core will determine Vitamin D receptor polymorphisms on de-identified samples. No clinical information will accompany the samples.
| Enrollment: | 362 |
| Study Start Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Vitamin D
Specimen analysis
|
Other: Vitamin D
N/A, frozen specimen study
|
Eligibility| Ages Eligible for Study: | 45 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
obese, older men and postmenopausal women
Inclusion Criteria: 45-85 years of age
Exclusion Criteria: none
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Contacts and Locations
More Information
No publications provided
| Responsible Party: | Andrew P. Goldberg, Chair BVAMC GRECC, Baltimore VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT01798030 History of Changes |
| Other Study ID Numbers: | 43973 |
| Study First Received: | February 21, 2013 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Baltimore VA Medical Center:
|
Vitamin D Diabetes Osteoporosis Cardiovascular Risk |
Additional relevant MeSH terms:
|
Hyperlipidemias Osteoporosis Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Vitamin D Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013