To assess whether supplemention of vitamin D3 (1200 IU/day) in vitamin-D deficient non-western immigrants at risk for type 2 diabetes mellitus can improve the insulin resistance and betacell function as well.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Vitamin related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome are the incremental Area Under the Curve (AUC) of glucose of
insulin after a 75 g oral glucose tolerance test (OGTT).
Secondary outcome
Secondary outcome measures are fasting serum lipids, BMI and physical
performance.
Background summary
Both type 2 diabetes mellitus and vitamin D deficiency have a high prevalence
rate in non-western immigrants. A 50% prevalence of vitamin D deficiency,
defined as serum 25-hydroxyvitamin D < 25nmol/l, was found in Turkish and
Moroccan immigrants in the Netherlands.
Beside the well known effects of vitamin D on calcium and bone homeostasis
vitamin D exerts important physiological effects on muscle strength, physical
performance and the immune system. Moreover, vitamin D appears to enhance
insulin secretion and insulin sensitivity. As a consequence, treatment of
vitamin D deficiency in non-western immigrants at risk for diabetes could
contribute to the prevention of type 2 diabetes mellitus.
Study objective
To assess whether supplemention of vitamin D3 (1200 IU/day) in vitamin-D
deficient non-western immigrants at risk for type 2 diabetes mellitus can
improve the insulin resistance and betacell function as well.
Study design
The study is designed as a randomised double blind, placebo-controlled trial,
with an intervention and a control group It will last for 4 months. At 0 and 4
months an oral glucose tolerance test will be performed.
Intervention
The intervention group (1) will receive vitamin D3 1200 IU/day in addition to
calcium 500mg (2); the control group will receive calcium 500mg only.
Study burden and risks
The visits to the hospital and the oral glucose tolerance tests may cause some
discomfort to the subjects, however this is only at a limited degree. The oral
glucose tolerance test is a common test at the policlinics. The medication has
to be taken due to the vitamin D deficiency.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
vitamin D deficiency, impaired fasting or at random bloodglucose
Exclusion criteria
serious illness, diabetes mellitus, severe vitamin D deficiency, concurrent medication that may interfere with the interpretation of the data of the study, serious mental impairment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25585.029.08 |