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Completed

NCT Number: NCT01497132

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Avitaminosis Deficiency Diseases Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dpt of Endocrinology, Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Drug

Oral drops 30000 IU weekly

Other names: Vigantol oil

Placebo

Drug

Matching placebo

Primary outcomes

  1. Beta cell function

    Time frame: 8 weeks

    Assessed by hyperglycemic clamp investigation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: EVIDENS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 22, 2011
Registry last updated
Sep 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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