Vitamin D and Type 2 Diabetes - a Cross Sectional Study

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Regionshospitalet Silkeborg
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00695474
First received: June 9, 2008
Last updated: July 10, 2009
Last verified: July 2009
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lifestyle (exercise, sun exposure, food intake) [ Time Frame: December 08 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MD, Med. Sci. Lotte Oerskov, Medical Department, Silkeborg Hospital
ClinicalTrials.gov Identifier: NCT00695474     History of Changes
Other Study ID Numbers: M-20080061
Study First Received: June 9, 2008
Last Updated: July 10, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

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
Rickets
Avitaminosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014