Diabetes Mellitus Type 2Phase 2DIVINENCT00992797
Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity
A Phase 2 study testing Cholecalciferol and Orange juice in people with Diabetes Mellitus Type 2 and Hypovitaminosis D, run by University Hospital, Aker at 1 site in Norway.
Trial summary
The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Hypovitaminosis D
- What is being tested?
- Cholecalciferol and Orange juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Dec 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate (S-25OHD 25-50 nmol/l) to severe (S-25OHD < 25 nmol/l) vitamin D deficiency measured at Visit 1.
- Patients with type 2 diabetes, including drug naïve subjects, subjects using oral anti-diabetic medication and subjects on insulin treatment. All medication must be in stable doses during the 4 week lead-in period.
- HbA1c < 11 % at Visit 1.
- Able to communicate in Norwegian.
- Men and women ≥ 18 years.
- Norwegian or South Asian ethnicity.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study. All WOCBP must have negative serum or urine pregnancy test at enrollment, randomization, titration visit and final study assessment.
- Antihypertensive medication, lipid lowering drugs, oral contraceptives, hormone replacement therapy, multivitamin supplements and nutritional supplements are allowed if the subjects adhere to the same regimen during the study
Who cannot join
- Subjects not having type 2 diabetes.
- SBP ≥ 160 or DBP ≥ 95 at Visit 1.
- Significant renal disease or chronic renal impairment, GFR< 30 ml/min.
- Significant liver disease or ASAT or ALAT >3x UNL.
- Malignancy during the last five years.
- Hypercalcemia at Visit 1.
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- A history of kidney stone disease
- WOCBP unwilling or unable to use an acceptable method to avoid pregnancy.
- Pregnant or breastfeeding women.
- Chronic inflammatory disease in active phase
- Long term (>2 weeks) use of corticosteroids last 3 months
- Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the study.
- Drug or alcohol abuse.
- BMI > 45 kg/m2 or bariatric surgery (<5 years).
- Anemia
- Cardiovascular disease (myocardial infarction, unstable angina pectoris or stroke) during the last 6 months.
- Any medical condition that in the judgment of the investigator would jeopardize the subject's safety or evaluation of the study drug for efficacy and safety.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Diabetes Laboratory, Oslo University Hospital Aker
Oslo, 0514
4722894745, diabeteslab@aus.no
Kåre I Birkeland, MD PhD
About this study
Official title: A Randomized Controlled Trial of the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Subjects With Type 2 Diabetes of Nordic and Sub-Indian Ethnicity .
The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.
Read the detailed description
Accumulating evidence suggests that hypovitaminosis D may be associated with the development of type 2 diabetes and disturbances in glucose and insulin metabolism. There is lack of data from randomized, controlled studies of sufficient duration and with the use of sufficient doses of vitamin D to assess the importance of vitamin D supplementation in glucose metabolism in type 2 diabetes.
- Conditions
- Diabetes Mellitus Type 2, Hypovitaminosis D
- Being tested
- Cholecalciferol, Orange juice
- Keywords
- Insulin resistance, Insulin secretory dysfunction, Inflammation, Vascular stiffness
- Medical subject headings
- Diabetes Mellitus, Type 2, Vitamin D Deficiency, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D, ZymaD
Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D < 100 nmol/L. If serum 25(OH)D > 100 placebo will be given. The cholecalciferol will be given in orange juice.
Orange juiceOther
Orange juice at randomization day and at week 5.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Experimental | Not described Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | Not described Receives: Other: Orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp
Measured: Before and after the 6 months intervention period
Secondary outcomes (9)
Insulin secretion measured with IVGTT
Measured: At 0 and 6 months
Physical activity/muscle strength
Measured: At 0 and 6 months
HbA1c and fasting glucose
Measured: At 0, 3 and 6 months
Arterial stiffness
Measured: At 0 and 6 months
Differences in inflammatory markers, endothelial function and bone specific laboratory markers.
Measured: At 0, 3 and 6 months
Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction.
Measured: Entire intervention period, samples taken at 0,1,3, and 6 months
Change from baseline in quality of life score between groups (SF-36).
Measured: At 0 and 6 months
Effect on serum lipid levels and other biochemical markers
Measured: At 0, 3 and 6 months
Metabolomics analyses.
Measured: At 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aker
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Kåre I Birkeland, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992797
- Sponsor's protocol ID
- AUS-KIB-001
- Acronym
- DIVINE
- Status last verified
- Nov 2009
- First submitted
- 5 Oct 2009
- Last updated
- 3 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gulseth HL, Wium C, Angel K, Eriksen EF, Birkeland KI. Effects of Vitamin D Supplementation on Insulin Sensitivity and Insulin Secretion in Subjects With Type 2 Diabetes and Vitamin D Deficiency: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):872-878. doi: 10.2337/dc16-2302. Epub 2017 May 3.
PubMed 28468770
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Subjects With Type 2 Diabetes of Nordic and Sub-Indian Ethnicity .
- ClinicalTrials.gov ID
- NCT00992797
- Acronym / sponsor ID
- DIVINE / AUS-KIB-001
- Conditions
- Diabetes Mellitus Type 2, Hypovitaminosis D
- Keywords
- Insulin resistance, Insulin secretory dysfunction, Inflammation, Vascular stiffness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AkerUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Oct 2009 (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 aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.
Detailed description
Accumulating evidence suggests that hypovitaminosis D may be associated with the development of type 2 diabetes and disturbances in glucose and insulin metabolism. There is lack of data from randomized, controlled studies of sufficient duration and with the use of sufficient doses of vitamin D to assess the importance of vitamin D supplementation in glucose metabolism in type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Experimental | Drug: Cholecalciferol |
| Placebo | Placebo comparator | Other: Orange juice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Moderate (S-25OHD 25-50 nmol/l) to severe (S-25OHD < 25 nmol/l) vitamin D deficiency measured at Visit 1.
- Patients with type 2 diabetes, including drug naïve subjects, subjects using oral anti-diabetic medication and subjects on insulin treatment. All medication must be in stable doses during the 4 week lead-in period.
- HbA1c < 11 % at Visit 1.
- Able to communicate in Norwegian.
- Men and women ≥ 18 years.
Key exclusion criteria (17 listed)
- Subjects not having type 2 diabetes.
- SBP ≥ 160 or DBP ≥ 95 at Visit 1.
- Significant renal disease or chronic renal impairment, GFR< 30 ml/min.
- Significant liver disease or ASAT or ALAT >3x UNL.
- Malignancy during the last five years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: Vitamin D, ZymaDCholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D < 100 nmol/L. If serum 25(OH)D > 100 placebo will be given. The cholecalciferol will be given in orange juice. | Drug | Cholecalciferol |
| Orange juiceOrange juice at randomization day and at week 5. | Other | Placebo |
Primary outcome
Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp
Time frame: Before and after the 6 months intervention period
9 secondary outcomes
Insulin secretion measured with IVGTT
Time frame: At 0 and 6 months
Physical activity/muscle strength
Time frame: At 0 and 6 months
HbA1c and fasting glucose
Time frame: At 0, 3 and 6 months
Arterial stiffness
Time frame: At 0 and 6 months
Differences in inflammatory markers, endothelial function and bone specific laboratory markers.
Time frame: At 0, 3 and 6 months
Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction.
Time frame: Entire intervention period, samples taken at 0,1,3, and 6 months
Change from baseline in quality of life score between groups (SF-36).
Time frame: At 0 and 6 months
Effect on serum lipid levels and other biochemical markers
Time frame: At 0, 3 and 6 months
Metabolomics analyses.
Time frame: At 0 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2009.
- Derived from this study: PubMed 28468770Gulseth HL, Wium C, Angel K, Eriksen EF, Birkeland KI. Effects of Vitamin D Supplementation on Insulin Sensitivity and Insulin Secretion in Subjects With Type 2 Diabetes and Vitamin D Deficiency: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):872-878. doi: 10.2337/dc16-2302. Epub 2017 May 3.
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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.
Kåre I Birkeland, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol and Orange juice in people with Diabetes Mellitus Type 2 and Hypovitaminosis D, run by University Hospital, Aker at 1 site in Norway.
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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 3 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gulseth Wium, MD (4722894745, diabeteslab@aus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp (time frame: Before and after the 6 months intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00992797, which also lists 1 linked publication.
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 3 Nov 2009.