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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02112721
Registration number
NCT02112721
Ethics application status
Date submitted
10/04/2014
Date registered
14/04/2014
Date last updated
8/12/2016
Titles & IDs
Public title
Can Vitamin D Supplementation Prevent Type 2 Diabetes?
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Scientific title
Can Vitamin D Supplementation Prevent Type 2 Diabetes by Improving Insulin Sensitivity and Secretion in Overweight Humans?
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Secondary ID [1]
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1047897
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Vitamin D
Other interventions - Placebo
Experimental: Vitamin D Group - 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.
Placebo Comparator: Placebo group - Each participant will be given an equivalent number of placebo tablets
Other interventions: Vitamin D
Other interventions: Placebo
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Initial Insulin Sensitivity Measure using Euglycaemic glucose clamp
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Assessment method [1]
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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.
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Timepoint [1]
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Week 1
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Primary outcome [2]
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Follow up Insulin Sensitivity Measure using Euglycaemic glucose clamp
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Assessment method [2]
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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.
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Timepoint [2]
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Week 17
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Secondary outcome [1]
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Initial measurement of inflammatory markers
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Assessment method [1]
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Plasma inflammatory markers (interleukin 1ß, 6, 8 and 10, TNFa, 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).
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Timepoint [1]
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Week 1
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Secondary outcome [2]
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Follow Up Measurement of inflammatory markers
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Assessment method [2]
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Plasma inflammatory markers (interleukin 1ß, 6, 8 and 10, TNFa, 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).
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Timepoint [2]
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Week 17
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Secondary outcome [3]
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Initial Measure of Adiposity (DEXA)
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Assessment method [3]
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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.
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Timepoint [3]
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Week 1
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Secondary outcome [4]
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Follow Up Measure of Adiposity (DEXA)
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Assessment method [4]
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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.
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Timepoint [4]
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Week 17
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Secondary outcome [5]
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Initial Oral Glucose Tolerance Test - OGTT
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Assessment method [5]
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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.
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Timepoint [5]
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Week 1
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Secondary outcome [6]
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Follow Up Oral Glucose Tolerance Test -OGTT
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Assessment method [6]
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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.
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Timepoint [6]
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Week 17
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Secondary outcome [7]
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Initial Acute Insulin Secretory Response - Intravenous Glucose Tolerance Test
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Assessment method [7]
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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.
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Timepoint [7]
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Week 1
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Secondary outcome [8]
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Follow up Acute Insulin Secretory Response- Intravenous Glucose Tolerance Test
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Assessment method [8]
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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.
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Timepoint [8]
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Week 17
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Eligibility
Key inclusion criteria
- 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
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2016
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Sample size
Target
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Accrual to date
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Final
55
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Centre for Health Research and Implementation - Melbourne
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Recruitment postcode(s) [1]
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3168 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Victoria
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Auckland, New Zealand
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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:
1. improve insulin sensitivity (in vivo and tissue) and/or insulin secretory function
2. determine whether this relationship is mediated by a reduced chronic inflammation
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02112721
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Barbora de Courten, PhD, MD
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02112721
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