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

This study is currently recruiting participants.
Verified May 2012 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Henrik Wagner, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01497132
First received: December 20, 2011
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Glucose Intolerance
Vitamin D Deficiency
 Drug: Vitamin D3
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Beta cell function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assessed by hyperglycemic clamp investigation


Secondary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assessed by hyperglycemic clamp investigation

  • Glucose tolerance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assessed by OGTT

  • Hypercalcemia [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: January 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3 Drug: Vitamin D3
Oral drops 30000 IU weekly
Other Name: Vigantol oil
Placebo Comparator: Placebo Drug: Placebo
Matching placebo

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497132

Contacts
Contact: Claes Göran Östensson, Professor +46-8-517 762 00 claes-goran.ostenson@ki.se

Locations
Sweden
Dpt of Endocrinology, Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Henrik Wagner, M.D     +46-8-517 793 38     henrik.wagner@karolinska.se    
Principal Investigator: Henrik Wagner, M.D            
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Henrik Wagner, M.D Karolinska Institutet
  More Information

No publications provided

Responsible Party: Henrik Wagner, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01497132     History of Changes
Other Study ID Numbers: DvitamininDM2_v1_110815, 2010-024487-18
Study First Received: December 20, 2011
Last Updated: May 22, 2012
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vitamin D Deficiency
Glucose Intolerance
Prediabetic State
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Hyperglycemia
Hyperinsulinism
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013