Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2

Diabetes Mellitus, Type 2 Clinical Trial

— EVIDENS  

Official title:

Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497132
• Other study ID #: DvitamininDM2_v1_110815
• Secondary ID: 2010-024487-18
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2011
• Last updated: September 9, 2014
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: September 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D3
Oral drops 30000 IU weekly
• Placebo
Matching placebo

Locations

Country	Name	City	State
Sweden	Dpt of Endocrinology, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta cell function	Assessed by hyperglycemic clamp investigation	8 weeks	No
Secondary	Insulin sensitivity	Assessed by hyperglycemic clamp investigation	8 weeks	No
Secondary	Glucose tolerance	Assessed by OGTT	8 weeks	No
Secondary	Hypercalcemia		8 weeks	Yes