A moderately high vitamin D3 supplementation will improve pre-diabetes parameters in non-western immigrants with a vitamin D deficiency and obesity.
ID
Bron
Verkorte titel
Aandoening
Vitamin D deficiency, insulin resistence, non-western immigrants, prevention of type 2 diabetes mellitus .
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
What is the effect of vitamin D supplementation on insulin sensitivity parameters derived from the OGTT in non-western immigrants at risk for diabetes mellitus?
Achtergrond van het onderzoek
In this randomised controlled trial we study the effect of moderately high dose vitamin D supplemtation on insulin sensitivity, glucose metabolism, vascular function and physical performance in non western immigrants at risk for type 2 diabetes mellitus in the Netherlands.
Doel van het onderzoek
A moderately high vitamin D3 supplementation will improve pre-diabetes parameters in non-western immigrants with a vitamin D deficiency and obesity.
Onderzoeksopzet
1. 0,2 and 4 months;
2. OGTT;
3. Physical performance test;
4. LASA-score;
5. Vascular functiontest;
6. Bloodtest.
Onderzoeksproduct en/of interventie
4 months vitamin D 1200 IE/calcium 500 mg once daily, vs 4 months placebo/calcium 500 mg once daily.
Publiek
M.M. Oosterwerff
VU University Medical Center,
Department of Endocrinology/research
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444444
m.oosterwerff@vumc.nl
Wetenschappelijk
M.M. Oosterwerff
VU University Medical Center,
Department of Endocrinology/research
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444444
m.oosterwerff@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Written informed consent;
2. Non-western immigrants, male and female;
3. Aged between 20 and 65 years;
4. A body mass index (BMI) above 27(kg/m2);
5. Vitamin D deficiency and insufficiency;
6. An impaired fasting glucose and/or an impaired random serum glucose;
7. Ability to comply with all study requirements.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnant or lactating women, or subjects who intend to become pregnant within the study period;
2. Severe vitamin D deficiency;
3. A history of type 1 diabetes mellitus, secondary diabetes mellitus, acute diabetic complications;
4. Concurrent medication that may interfere with the interpretation of the data of the study;
5. Badly controlled thyroid and/or adrenal disease;
6. Serious physical impairment;
7. Serious diseases;
8. Serious mental impairment.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1717 |
| NTR-old | NTR1827 |
| Ander register | MEC VUMC : 2008/270 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |