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Vitamin D and Type 2 Diabetes - a Cross Sectional Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695474
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : July 14, 2009
Aarhus University Hospital
Regionshospitalet Silkeborg
Information provided by:
University of Aarhus

Brief Summary:
The purpose of the study is to describe vitamin D status among patients with type 2 diabetes and to determine the association between serum 25-hydroxyvitamin D and glycemic control, markers of inflammation and blood pressure

Condition or disease
Hypovitaminosis D Type 2 Diabetes Mellitus

Detailed Description:

It has been estimated that 1 billion people worldwide have vitamin D deficiency or insufficiency. It is well known that vitamin D deficiency causes osteoporosis, increases the risk of fracture and causes muscle weakness. But there is now evidence that calcium malnutrition and hypovitaminosis D are predisposing conditions for various common chronic diseases such as malignancies (particularly colon, breast and prostate) chronic inflammatory and autoimmune disease (inflammatory bowel disease, multiple sclerosis) as well as metabolic disorders (metabolic syndrome, hypertension).

It has also been reported that vitamin D deficiency may predispose to glucose intolerance, altered insulin secretion and type 2 diabetes mellitus.

The purpose of this study is to determine vitamin D status among type 2 diabetics in our outpatient clinic and examine the relationship between vitamin D status , calcium and phosphorous metabolism, inflammatory markers, glycemic control, blood pressure and lipid profile.

Moreover the patients are asked to answer a questionnaire regarding lifestyle, exercise, sun exposure and food intake.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Vitamin D and Type 2 Diabetes - a Cross Sectional Study
Study Start Date : June 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

The cohort consists of type 2 diabetics from the outpatient clinic at Silkeborg Hospital.

Primary Outcome Measures :
  1. Vitamin D status and its association with inflammation, glycemic control, lipids and blood pressure. [ Time Frame: December 08 ]

Secondary Outcome Measures :
  1. Lifestyle (exercise, sun exposure, food intake) [ Time Frame: December 08 ]

Biospecimen Retention:   Samples With DNA
Blood samples, urine.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of Danish type 2 diabetics from the outpatient clinic at Silkeborg Hospital.

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Patients of Danish extraction
  • Written consent

Exclusion Criteria:

  • Renal failure (Urea > 12 mmol/l)
  • Age < 18 years
  • malabsorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00695474

Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Regionshospitalet Silkeborg
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Principal Investigator: Lotte Oeskov, MD Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
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Responsible Party: MD, Med. Sci. Lotte Oerskov, Medical Department, Silkeborg Hospital Identifier: NCT00695474    
Other Study ID Numbers: M-20080061
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009
Keywords provided by University of Aarhus:
Hypovitaminosis D
Type 2 diabetes
Glycemic control
Blood pressure
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Deficiency Diseases
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders