Type 2 Diabetes MellitusPhase 4NCT02112721
Can Vitamin D Supplementation Prevent Type 2 Diabetes?
A Phase 4 study testing Vitamin D in people with Type 2 Diabetes Mellitus, run by Monash University at 1 site in Australia.
Trial summary
The aim of this study is to determine whether vitamin D supplementation in overweight/obese individuals with vitamin D deficiency can improve insulin secretion and/or insulin resistance by decreasing subclinical inflammation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteAustralia
- Study dates
- May 2014to Nov 2016
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >18 or <60 years,
- 25(OH)D < 50 nmol/L
- Weight change < 5 kg in last 12 months
- BMI >25kg/m2 but weight <159kg due to DEXA scan restrictions
- Non-diabetic, no allergy, non-smoker, no high alcohol use
- No current intake of medications including vitamin supplements
- No kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine or central nervous system disease, as well as no psychiatric disorders, no active cancer within the last five years; no presence of acute inflammation (by history, physical or laboratory examination)
- Not menopausal, pregnanct or lactating
Who cannot join
- Age <18 or > 60 years
- 25(OH)D > 50 nmol/L
- Weight change > 5 kg in last 12 months
- Diabetes (diagnosed or oral glucose tolerance test (OGTT), hypercalcaemia, allergy
- Current smoking habit, high alcohol use
- Current intake of medications including vitamin supplements
- Kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine or central nervous system disease, as well as psychiatric disorder, active cancer within the last five years; presence of acute inflammation (by history, physical or laboratory examination)
- Menopause, pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Australia1 site
Monash Centre for Health Research and Implementation
Melbourne, Victoria, 3168
About this study
Official title: Can Vitamin D Supplementation Prevent Type 2 Diabetes by Improving Insulin Sensitivity and Secretion in Overweight Humans?
The aim of this study is to determine whether vitamin D supplementation in overweight/obese individuals with vitamin D deficiency can improve insulin secretion and/or insulin resistance by decreasing subclinical inflammation.
Results of the present study may help to identify new strategies to prevent type 2 diabetes in high-risk groups (i.e. overweight and obese individuals, and individuals with a strong family history of diabetes).
Read more
Hypothesis: That increasing plasma 25(OH)D concentrations in healthy individuals at risk for type 2 diabetes with low vitamin D levels through vitamin D supplementation, will improve insulin sensitivity and also insulin secretion by reducing the underlying sub-clinical chronic inflammation.
Aims: To establish whether 16-week vitamin D supplementation given to healthy individuals with low vitamin D levels will:
- improve insulin sensitivity (in vivo and tissue) and/or insulin secretory function
- determine whether this relationship is mediated by a reduced chronic inflammation
Read the detailed description
Numerous studies documented that low vitamin D levels are a serious health risk. Despite the sunny climate in Australia, low vitamin D status is becoming increasingly prevalent and people with vitamin deficiency represent more than 30% of the healthy Australian population. Although sun exposure can maintain good vitamin D levels, often sun exposure is limited as people work long hours indoors, and use sunscreen or protective clothing to reduce skin cancer risk when outdoors. Moreover, it is difficult to obtain sufficient vitamin D from food alone; few foods are naturally rich in vitamin D and in Australia, few foods are fortified.
While the importance of vitamin D for bone mineralization is well known, it is less clear how vitamin D protects against type 2 diabetes and cardiovascular disease. Every day in Australia around 275 adults develop diabetes and its prevalence continues to rise.
We are therefore arguing for a well-designed intervention trial to define the preventive potential and physiological mechanisms of the effects of vitamin D supplementation. In addition, we plan to explore the mechanisms underlying the relationship between vitamin D deficiency and the risk for type 2 diabetes, via its influence on chronic inflammation. Our clinical trial will focus on healthy adults with low vitamin D status and will examine the effects on insulin sensitivity and secretion measured by 'gold standard' methodology when vitamin D is restored to optimum levels. It is in particularly important to determine whether vitamin D affects both or only one of these defects because there is evidence from observational studies that there is a relationship between vitamin D levels and both insulin sensitivity and secretion.
The proposed intervention study will potentially supply important evidence on how restoring vitamin D levels may protect against type 2 diabetes. Such findings could have direct relevance for novel approaches to diabetes prevention.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vitamin D, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Ostellin
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Group | Experimental | Each participant will be given an initial stat dose of 2500 μg (100,000 IU) of Ostelin (Reckitt Benckiser). Thereafter, participants will take 100 μg/day (4,000 IU, 4 tablets) Ostelin daily for a period of 16 weeks. Receives: Dietary Supplement: Vitamin D |
| Placebo group | Placebo comparator | Each participant will be given an equivalent number of placebo tablets Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial Insulin Sensitivity Measure using Euglycaemic glucose clamp
The clamp will be used to measure insulin sensitivity. The clamp is initiated by an intravenous bolus injection of insulin (9milliUnit/kg). Insulin is then constantly infused at a rate of 40 milliUnit.m-2.min-1 for 120 min into an arm vein, whilst glucose is variably infused to maintain euglycaemia. Plasma glucose values will be monitored every 5 minutes during the clamp and the variable infusion rate of glucose is adjusted to maintain blood glucose at a constant value of 5mmol/L.
Measured: Week 1
Follow up Insulin Sensitivity Measure using Euglycaemic glucose clamp
The clamp will be used to measure insulin sensitivity. The clamp is initiated by an intravenous bolus injection of insulin (9milliUnit/kg). Insulin is then constantly infused at a rate of 40 milliUnit.m-2.min-1 for 120 min into an arm vein, whilst glucose is variably infused to maintain euglycaemia. Plasma glucose values will be monitored every 5 minutes during the clamp and the variable infusion rate of glucose is adjusted to maintain blood glucose at a constant value of 5mmol/L.
Measured: Week 17
Secondary outcomes (8)
Initial measurement of inflammatory markers
Plasma inflammatory markers (interleukin 1β, 6, 8 and 10, TNFα, macrophage migration inhibitory factor, monocyte chemotactic protein-1) will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA) (interassay Coefficients of Variation: 7.2%, 10.2%, 5.8%, respectively). Plasma C- reactive protein (hsCRP) via a high sensitivity assay (BN-II nephelometer; Dade Behring Diagnostics, NSW).
Measured: Week 1
Follow Up Measurement of inflammatory markers
Plasma inflammatory markers (interleukin 1β, 6, 8 and 10, TNFα, macrophage migration inhibitory factor, monocyte chemotactic protein-1) will be measured by quantitative sandwich enzyme immunoassays (R \& D Systems Inc, USA) (interassay Coefficients of Variation: 7.2%, 10.2%, 5.8%, respectively). Plasma C- reactive protein (hsCRP) via a high sensitivity assay (BN-II nephelometer; Dade Behring Diagnostics, NSW).
Measured: Week 17
Initial Measure of Adiposity (DEXA)
body composition by dual energy x-ray absorptiometry (DEXA), which is a non-invasive assessment of soft tissue composition by region with a precision of 4-5%; central adiposity assessed in duplicate using a constant-tension tape for taking waist, and hip circumference. Bioimpedance measurement will be also collected for validation purposes.
Measured: Week 1
Follow Up Measure of Adiposity (DEXA)
body composition by dual energy x-ray absorptiometry (DEXA), which is a non-invasive assessment of soft tissue composition by region with a precision of 4-5%; central adiposity assessed in duplicate using a constant-tension tape for taking waist, and hip circumference. Bioimpedance measurement will be also collected for validation purposes.
Measured: Week 17
Initial Oral Glucose Tolerance Test - OGTT
After a 10-12 h overnight fast, participants will ingest 75g of glucose over 2 mins. Blood samples will be drawn at 0, 30, 60, 90 and 120 min for plasma glucose and insulin concentrations. We will evaluate the area under the curve.
Measured: Week 1
Follow Up Oral Glucose Tolerance Test -OGTT
After a 10-12 h overnight fast, participants will ingest 75g of glucose over 2 mins. Blood samples will be drawn at 0, 30, 60, 90 and 120 min for plasma glucose and insulin concentrations. We will evaluate the area under the curve.
Measured: Week 17
Initial Acute Insulin Secretory Response - Intravenous Glucose Tolerance Test
This will be measured in response to 25g intravenous glucose and calculated as the average incremental plasma insulin level from the third to the fifth minute after the glucose bolus.
Measured: Week 1
Follow up Acute Insulin Secretory Response- Intravenous Glucose Tolerance Test
This will be measured in response to 25g intravenous glucose and calculated as the average incremental plasma insulin level from the third to the fifth minute after the glucose bolus.
Measured: Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Victoria, University of Auckland, New Zealand
- Responsible party
- Principal investigator, Barbora de Courten, Monash University
- Investigators
- Barbora de Courten, PhD, MD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112721
- Sponsor's protocol ID
- 1047897
- Status last verified
- Dec 2016
- First submitted
- 10 Apr 2014
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stark R, Feehan J, Mousa A, Andrews ZB, de Courten B. Liver-expressed antimicrobial peptide 2 is associated with improved pancreatic insulin secretion in adults with overweight and obesity. Diabetes Obes Metab. 2023 May;25(5):1213-1220. doi: 10.1111/dom.14968. Epub 2023 Jan 19.
PubMed 36597795Mousa A, Naderpoor N, Wilson K, Plebanski M, de Courten MPJ, Scragg R, de Courten B. Vitamin D supplementation increases adipokine concentrations in overweight or obese adults. Eur J Nutr. 2020 Feb;59(1):195-204. doi: 10.1007/s00394-019-01899-5. Epub 2019 Jan 16.
PubMed 30649593Scott D, Mousa A, Naderpoor N, de Courten MPJ, Scragg R, de Courten B. Vitamin D supplementation improves waist-to-hip ratio and fasting blood glucose in vitamin D deficient, overweight or obese Asians: A pilot secondary analysis of a randomised controlled trial. J Steroid Biochem Mol Biol. 2019 Feb;186:136-141. doi: 10.1016/j.jsbmb.2018.10.006. Epub 2018 Oct 12.
PubMed 30321667Mousa A, Naderpoor N, de Courten MP, Teede H, Kellow N, Walker K, Scragg R, de Courten B. Vitamin D supplementation has no effect on insulin sensitivity or secretion in vitamin D-deficient, overweight or obese adults: a randomized placebo-controlled trial. Am J Clin Nutr. 2017 Jun;105(6):1372-1381. doi: 10.3945/ajcn.117.152736. Epub 2017 May 10.
PubMed 28490514de Courten B, Mousa A, Naderpoor N, Teede H, de Courten MP, Scragg R. Vitamin D supplementation for the prevention of type 2 diabetes in overweight adults: study protocol for a randomized controlled trial. Trials. 2015 Aug 7;16:335. doi: 10.1186/s13063-015-0851-6.
PubMed 26246241
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Vitamin D Supplementation Prevent Type 2 Diabetes by Improving Insulin Sensitivity and Secretion in Overweight Humans?
- ClinicalTrials.gov ID
- NCT02112721
- Acronym / sponsor ID
- 1047897
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- University of Victoria, University of Auckland, New Zealand
- Study start
- May 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Apr 2014 (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 study is to determine whether vitamin D supplementation in overweight/obese individuals with vitamin D deficiency can improve insulin secretion and/or insulin resistance by decreasing subclinical inflammation.
Results of the present study may help to identify new strategies to prevent type 2 diabetes in high-risk groups (i.e. overweight and obese individuals, and individuals with a strong family history of diabetes).
Hypothesis: That increasing plasma 25(OH)D concentrations in healthy individuals at risk for type 2 diabetes with low vitamin D levels through vitamin D supplementation, will improve insulin sensitivity and also insulin secretion by reducing the underlying sub-clinical chronic inflammation.
Aims: To establish whether 16-week vitamin D supplementation given to healthy individuals with low vitamin D levels will:
- improve insulin sensitivity (in vivo and tissue) and/or insulin secretory function
- determine whether this relationship is mediated by a reduced chronic inflammation
Detailed description
Numerous studies documented that low vitamin D levels are a serious health risk. Despite the sunny climate in Australia, low vitamin D status is becoming increasingly prevalent and people with vitamin deficiency represent more than 30% of the healthy Australian population. Although sun exposure can maintain good vitamin D levels, often sun exposure is limited as people work long hours indoors, and use sunscreen or protective clothing to reduce skin cancer risk when outdoors. Moreover, it is difficult to obtain sufficient vitamin D from food alone; few foods are naturally rich in vitamin D and in Australia, few foods are fortified.
While the importance of vitamin D for bone mineralization is well known, it is less clear how vitamin D protects against type 2 diabetes and cardiovascular disease. Every day in Australia around 275 adults develop diabetes and its prevalence continues to rise.
We are therefore arguing for a well-designed intervention trial to define the preventive potential and physiological mechanisms of the effects of vitamin D supplementation. In addition, we plan to explore the mechanisms underlying the relationship between vitamin D deficiency and the risk for type 2 diabetes, via its influence on chronic inflammation. Our clinical trial will focus on healthy adults with low vitamin D status and will examine the effects on insulin sensitivity and secretion measured by 'gold standard' methodology when vitamin D is restored to optimum levels. It is in particularly important to determine whether vitamin D affects both or only one of these defects because there is evidence from observational studies that there is a relationship between vitamin D levels and both insulin sensitivity and secretion.
The proposed intervention study will potentially supply important evidence on how restoring vitamin D levels may protect against type 2 diabetes. Such findings could have direct relevance for novel approaches to diabetes prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Group | Experimental | Dietary Supplement: Vitamin DEach participant will be given an initial stat dose of 2500 μg (100,000 IU) of Ostelin (Reckitt Benckiser). Thereafter, participants will take 100 μg/day (4,000 IU, 4 tablets) Ostelin daily for a period of 16 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboEach participant will be given an equivalent number of placebo tablets |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age >18 or <60 years,
- 25(OH)D < 50 nmol/L
- Weight change < 5 kg in last 12 months
- BMI >25kg/m2 but weight <159kg due to DEXA scan restrictions
- Non-diabetic, no allergy, non-smoker, no high alcohol use
Key exclusion criteria (8 listed)
- Age <18 or > 60 years
- 25(OH)D > 50 nmol/L
- Weight change > 5 kg in last 12 months
- Diabetes (diagnosed or oral glucose tolerance test (OGTT), hypercalcaemia, allergy
- Current smoking habit, high alcohol use
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 |
|---|---|---|
| Vitamin DAlso: Ostellin | Dietary supplement | Vitamin D Group |
| Placebo | Dietary supplement | Placebo group |
Primary outcome
Initial Insulin Sensitivity Measure using Euglycaemic glucose clamp
Time frame: Week 1
The clamp will be used to measure insulin sensitivity. The clamp is initiated by an intravenous bolus injection of insulin (9milliUnit/kg). Insulin is then constantly infused at a rate of 40 milliUnit.m-2.min-1 for 120 min into an arm vein, whilst glucose is variably infused to maintain euglycaemia. Plasma glucose values will be monitored every 5 minutes during the clamp and the variable infusion rate of glucose is adjusted to maintain blood glucose at a constant value of 5mmol/L.
Follow up Insulin Sensitivity Measure using Euglycaemic glucose clamp
Time frame: Week 17
The clamp will be used to measure insulin sensitivity. The clamp is initiated by an intravenous bolus injection of insulin (9milliUnit/kg). Insulin is then constantly infused at a rate of 40 milliUnit.m-2.min-1 for 120 min into an arm vein, whilst glucose is variably infused to maintain euglycaemia. Plasma glucose values will be monitored every 5 minutes during the clamp and the variable infusion rate of glucose is adjusted to maintain blood glucose at a constant value of 5mmol/L.
8 secondary outcomes
Initial measurement of inflammatory markers
Time frame: Week 1
Follow Up Measurement of inflammatory markers
Time frame: Week 17
Initial Measure of Adiposity (DEXA)
Time frame: Week 1
Follow Up Measure of Adiposity (DEXA)
Time frame: Week 17
Initial Oral Glucose Tolerance Test - OGTT
Time frame: Week 1
Follow Up Oral Glucose Tolerance Test -OGTT
Time frame: Week 17
Initial Acute Insulin Secretory Response - Intravenous Glucose Tolerance Test
Time frame: Week 1
Follow up Acute Insulin Secretory Response- Intravenous Glucose Tolerance Test
Time frame: Week 17
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 8 Dec 2016.
- Derived from this study: PubMed 36597795Stark R, Feehan J, Mousa A, Andrews ZB, de Courten B. Liver-expressed antimicrobial peptide 2 is associated with improved pancreatic insulin secretion in adults with overweight and obesity. Diabetes Obes Metab. 2023 May;25(5):1213-1220. doi: 10.1111/dom.14968. Epub 2023 Jan 19.
- Derived from this study: PubMed 30649593Mousa A, Naderpoor N, Wilson K, Plebanski M, de Courten MPJ, Scragg R, de Courten B. Vitamin D supplementation increases adipokine concentrations in overweight or obese adults. Eur J Nutr. 2020 Feb;59(1):195-204. doi: 10.1007/s00394-019-01899-5. Epub 2019 Jan 16.
- Derived from this study: PubMed 30321667Scott D, Mousa A, Naderpoor N, de Courten MPJ, Scragg R, de Courten B. Vitamin D supplementation improves waist-to-hip ratio and fasting blood glucose in vitamin D deficient, overweight or obese Asians: A pilot secondary analysis of a randomised controlled trial. J Steroid Biochem Mol Biol. 2019 Feb;186:136-141. doi: 10.1016/j.jsbmb.2018.10.006. Epub 2018 Oct 12.
- Derived from this study: PubMed 28490514Mousa A, Naderpoor N, de Courten MP, Teede H, Kellow N, Walker K, Scragg R, de Courten B. Vitamin D supplementation has no effect on insulin sensitivity or secretion in vitamin D-deficient, overweight or obese adults: a randomized placebo-controlled trial. Am J Clin Nutr. 2017 Jun;105(6):1372-1381. doi: 10.3945/ajcn.117.152736. Epub 2017 May 10.
- Derived from this study: PubMed 26246241de Courten B, Mousa A, Naderpoor N, Teede H, de Courten MP, Scragg R. Vitamin D supplementation for the prevention of type 2 diabetes in overweight adults: study protocol for a randomized controlled trial. Trials. 2015 Aug 7;16:335. doi: 10.1186/s13063-015-0851-6.
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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.
Barbora de Courten, PhD, MD principal investigator
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Type 2 Diabetes Mellitus, run by Monash University at 1 site in Australia.
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 8 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 8 Dec 2016. 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 Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Initial Insulin Sensitivity Measure using Euglycaemic glucose clamp (time frame: Week 1). The study lists 2 primary outcomes in all. 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 NCT02112721, which also lists 5 linked publications.
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 8 Dec 2016.