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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01497132
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vitamin D3 Drug: Vitamin D3
Oral drops 30000 IU weekly
Other Name: Vigantol oil
Placebo Comparator: Placebo Drug: Placebo
Matching placebo


Outcome Measures

Primary Outcome Measures :
  1. Beta cell function [ Time Frame: 8 weeks ]
    Assessed by hyperglycemic clamp investigation


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 8 weeks ]
    Assessed by hyperglycemic clamp investigation

  2. Glucose tolerance [ Time Frame: 8 weeks ]
    Assessed by OGTT

  3. Hypercalcemia [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497132


Locations
Sweden
Dpt of Endocrinology, Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Henrik Wagner, M.D Karolinska Institutet
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( EudraCT Number )
First Posted: December 22, 2011    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014

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