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Vitamin D and Type 2 Diabetes - a Cross Sectional Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695474
First Posted: June 11, 2008
Last Update Posted: July 14, 2009
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.
Collaborators:
Aarhus University Hospital
Regionshospitalet Silkeborg
Information provided by:
University of Aarhus
  Purpose
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
Hypovitaminosis D Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Vitamin D and Type 2 Diabetes - a Cross Sectional Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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

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

Biospecimen Retention:   Samples With DNA
Blood samples, urine.

Enrollment: 150
Study Start Date: June 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
The cohort consists of type 2 diabetics from the outpatient clinic at Silkeborg Hospital.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Renal failure (Urea > 12 mmol/l)
  • Age < 18 years
  • malabsorption
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00695474


Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Regionshospitalet Silkeborg
Investigators
Principal Investigator: Lotte Oeskov, MD Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
  More Information

Responsible Party: MD, Med. Sci. Lotte Oerskov, Medical Department, Silkeborg Hospital
ClinicalTrials.gov Identifier: NCT00695474     History of Changes
Other Study ID Numbers: M-20080061
First Submitted: June 9, 2008
First Posted: June 11, 2008
Last Update Posted: July 14, 2009
Last Verified: July 2009

Keywords provided by University of Aarhus:
Hypovitaminosis D
Type 2 diabetes
Glycemic control
Inflammation
Blood pressure

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Avitaminosis
Rickets
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents