Vitamin D and Type 2 Diabetes - a Cross Sectional Study

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Vitamin D and Type 2 Diabetes - a Cross Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695474
• Other study ID #: M-20080061
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: July 10, 2009
• Start date: June 2008
• Est. completion date: April 2009

Study information

• Verified date: July 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus

• Patients of Danish extraction

• Written consent

Exclusion Criteria:

• Renal failure (Urea > 12 mmol/l)

• Age < 18 years

• malabsorption

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Avitaminosis
• Diabetes Mellitus, Type 2
• Hypovitaminosis D
• Rickets
• Type 2 Diabetes Mellitus
• Vitamin D Deficiency

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Regionshospitalet Silkeborg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D status and its association with inflammation, glycemic control, lipids and blood pressure.		December 08	No
Secondary	Lifestyle (exercise, sun exposure, food intake)		December 08	No