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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Glucose Intolerance; Vitamin D Deficiency
• Interventions: Drug: Placebo; Drug: Vitamin D3

• Registration Number: NCT01497132
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Study Start: 2012-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-09
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Vitamin D3	Vitamin D3	-

Primary Outcome Measures

Name	Time	Method
Beta cell function	8 weeks	Assessed by hyperglycemic clamp investigation

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity	8 weeks	Assessed by hyperglycemic clamp investigation
Hypercalcemia	8 weeks
Glucose tolerance	8 weeks	Assessed by OGTT

Trial Locations

Locations (1)

Dpt of Endocrinology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden