Status:
COMPLETED
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2
Lead Sponsor:
Karolinska Institutet
Conditions:
Diabetes Mellitus, Type 2
Glucose Intolerance
Eligibility:
All Genders
45-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.
Eligibility Criteria
Inclusion
- Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
- BMI ≤ 32 kg/m2.
- HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
- Fasting plasma glucose \< 9 mmol/l
- S-25-OH-vitamin D3 \< 75 nmol/l.
Exclusion
- Treatment with any vitamin D preparation.
- Regular sun-bathing in solarium.
- Hypercalcemia at screening, defined as free s-calcium \> 1.35 mmol/l.
- Hyperphosphatemia at screening, defined as s-phosphate \> 1.5 mmol/l.
- Sarcoidosis or other granulomatous disease.
- Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
- Impaired hepatic function.
- Impaired renal function
- Cardiac disease defined as:
- Unstable angina pectoris
- Myocardial infarction within the last 6 months
- Congestive heart failure NYHA class III and IV
- Cerebral stroke within the last 6 months.
- Anti-diabetic medication of any kind.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01497132
Start Date
January 1 2012
End Date
May 1 2013
Last Update
September 10 2014
Active Locations (1)
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1
Dpt of Endocrinology, Karolinska University Hospital
Stockholm, Stockholm County, Sweden, 17176