Vitamin D AND Glucose Handling Evaluated by Glucose Clamp
D-clamp
Vitamin D AND Cardiovascular Disease
1 other identifier
interventional
160
1 country
1
Brief Summary
In this study the investigators want to compare glucose handling (insulin secretion and insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of vitamin D, using a hyperglycemic clamp technique, were sugar is given intravenously for 3 hours in order to keep the blood sugar level at 10 mmol/L. Those with low vitamin D levels will be randomized to treatment with vitamin D3 (cholecalciferol) 40 000 IU/week or placebo for 6 months before a new clamp is performed. The study hypothesis is that persons with low vitamin D levels have impaired glucose handling which might be improved by vitamin D supplementation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedNovember 3, 2011
November 1, 2011
2.1 years
December 16, 2008
November 2, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
insulin secretion and sensitivity as assessed by an hyperglycemic clamp
6 months
intraocular pressure
6 months
Secondary Outcomes (4)
telomer length
6 months
25-hydroxyvitamin D and 1,25-dihydroxyvitamin D-levels
6 months
serum calcium, PTH, phosphate
6 months
inflammatory markers and lipids
6 months
Interventions
capsules, 20 000IU, twice a week, 6 months duration
Eligibility Criteria
You may qualify if:
- generally: Subjects are recruited from the 6th Tromsø Study
- cases: serum 25-hydroxyvitamin D-levels below the 10 percentile; low levels confirmed with new serum analyses.
- controls: serum 25-hydroxyvitamin D levels 80-95 percentile, normal-high levels confirmed with new serum analyses.
You may not qualify if:
- diabetes
- myocardial infarction or apoplexia
- active cancer during last 5 years
- history of kidney stone
- pregnancy or premenopausal without safe anticonception
- primary hyperparathyroidism
- systolic blood pressure \>175 or diastolic blood pressure \>105
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of North Norway
Tromsø, 9037, Norway
Related Publications (1)
Grimnes G, Figenschau Y, Almas B, Jorde R. Vitamin D, insulin secretion, sensitivity, and lipids: results from a case-control study and a randomized controlled trial using hyperglycemic clamp technique. Diabetes. 2011 Nov;60(11):2748-57. doi: 10.2337/db11-0650. Epub 2011 Sep 12.
PMID: 21911741DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rolf Jorde, Professor
Medical Dpt, University Hospital of Northern Norway
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 17, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
November 3, 2011
Record last verified: 2011-11