Suspended

Association of Vitamin D With Diabetes, Osteoporosis and Cardiovascular Risk

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
OtherDNA Samples
Who is being recruted

Bone Diseases+9

+ Bone Diseases, Metabolic

+ Endocrine System Diseases

From 45 to 85 Years
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: November 2009
See protocol details

Summary

Principal SponsorBaltimore VA Medical Center
Last updated: July 20, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2009

Actual date on which the first participant was enrolled.

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.

Principal SponsorBaltimore VA Medical Center
Last updated: July 20, 2021
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

362 patients to be enrolled

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

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.


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 45 to 85 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

Bone DiseasesBone Diseases, MetabolicEndocrine System DiseasesMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDyslipidemiasLipid Metabolism DisordersDiabetes MellitusHyperlipidemiasOsteoporosis

Criteria

Inclusion Criteria: 45-85 years of age Exclusion Criteria: none -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

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

Baltimore VAMC

Baltimore, United StatesOpen Baltimore VAMC in Google Maps
SuspendedOne Study Center