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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henrik Wagner, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01497132
First received: December 20, 2011
Last updated: September 9, 2014
Last verified: September 2014
  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:


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 ]

Enrollment: 44
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: September 9, 2014
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperglycemia
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014