Hypovitaminosis DNCT00695474
Vitamin D and Type 2 Diabetes - a Cross Sectional Study
An observational study of Hypovitaminosis D and Type 2 Diabetes Mellitus, run by University of Aarhus.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypovitaminosis D, Type 2 Diabetes Mellitus
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of Danish type 2 diabetics from the outpatient clinic at Silkeborg Hospital.
Who may be able to join
- Type 2 diabetes mellitus
- Patients of Danish extraction
- Written consent
Who cannot join
- Renal failure (Urea > 12 mmol/l)
- Age < 18 years
- malabsorption
About this study
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
Read the 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.
- Conditions
- Hypovitaminosis D, Type 2 Diabetes Mellitus
- Keywords
- Hypovitaminosis D, Type 2 diabetes, Glycemic control, Inflammation, Blood pressure
- Medical subject headings
- Vitamin D Deficiency, Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | The cohort consists of type 2 diabetics from the outpatient clinic at Silkeborg Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D status and its association with inflammation, glycemic control, lipids and blood pressure.
Measured: December 08
Secondary outcomes (1)
Lifestyle (exercise, sun exposure, food intake)
Measured: December 08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg
- Investigators
- Lotte Oeskov, MD, Principal investigator, Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695474
- Sponsor's protocol ID
- M-20080061
- Status last verified
- Jul 2009
- First submitted
- 9 Jun 2008
- Last updated
- 14 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Type 2 Diabetes - a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT00695474
- Acronym / sponsor ID
- M-20080061
- Conditions
- Hypovitaminosis D, Type 2 Diabetes Mellitus
- Keywords
- Hypovitaminosis D, Type 2 diabetes, Glycemic control, Inflammation, Blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg
- Study start
- Jun 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –The cohort consists of type 2 diabetics from the outpatient clinic at Silkeborg Hospital. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of Danish type 2 diabetics from the outpatient clinic at Silkeborg Hospital.
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- Patients of Danish extraction
- Written consent
Key exclusion criteria (3 listed)
- Renal failure (Urea > 12 mmol/l)
- Age < 18 years
- malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamin D status and its association with inflammation, glycemic control, lipids and blood pressure.
Time frame: December 08
1 secondary outcome
Lifestyle (exercise, sun exposure, food intake)
Time frame: December 08
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2009.
Related trials for Hypovitaminosis D
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lotte Oeskov, MD principal investigator
Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovitaminosis D and Type 2 Diabetes Mellitus, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D status and its association with inflammation, glycemic control, lipids and blood pressure. (time frame: December 08). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2009.