Vitamin D and Type 2 Diabetes - a Cross Sectional Study

July 10, 2009 updated by: University of Aarhus

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of Danish type 2 diabetics from the outpatient clinic at Silkeborg Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
A The cohort consists of type 2 diabetics from the outpatient clinic at Silkeborg Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vitamin D status and its association with inflammation, glycemic control, lipids and blood pressure. Time Frame: December 08	December 08

Secondary Outcome Measures

Outcome Measure	Time Frame
Lifestyle (exercise, sun exposure, food intake) Time Frame: December 08	December 08

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Regionshospitalet Silkeborg

Investigators

Principal Investigator: Lotte Oeskov, MD, Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria