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NCT Number: NCT01889810

Effect of Vitamin D3 Supplementation on Insulin Resistance- The DIR Study

Insulin resistance is a state where the body does not respond as it should to the insulin it produces. Individuals who are insulin resistant are at increased risk of both heart disease and type 2 diabetes; importantly, diabetes more than doubles the risk of heart disease, independent of other recognised risk factors. Interventions that prevent or reverse insulin resistance may help to attenuate risk of heart disease and diabetes. A number of randomised controlled trials provide proof of concept evidence regarding a beneficial effect of vitamin D on insulin resistance and other cardiovascular risk markers but experts have stated that further studies are required. Importantly, these studies should use appropriate endpoints, provide a high enough dose of vitamin D to optimise vitamin D status, and they should be conducted in clearly defined populations, The vitamin D trial we propose addresses these issues and aims to evaluate a potentially straightforward and low cost health care intervention for populations at highrisk of heart disease and diabetes. Specifically, this study would provide clinically relevant information on the metabolic effects of optimising vitamin D status in these high risk patients. This has clear economic and social implications given the current, and projected, burden of heart disease and diabetes.

This study will investigate the effect of vitamin D3 supplementation on insulin resistance and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular disease using the gold standard euglycaemic hyperinsulinaemic clamp method.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University, Belfast

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Impaired glucose tolerance (Fasting glucose <7.0 mmol/L (126mg/dl) and 2hr post-glucose load 7.8-11.0 mmol/L (140-199 mg/dl) or Impaired fasting glucose 5.6-6.9 mmol/L (100-125mg/dL) defined according to American Diabetes Association
  • Sub-optimal vitamin D status (<50nmol/L)

Exclusion criteria

  • Diabetes mellitus
  • Established cardiovascular disease
  • Psychiatric problems
  • Pregnant or lactating
  • Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
  • Excessive alcohol consumption (>28 Units/week men or >21 Units/week women)
  • Already taking vitamin D supplements > 10 µg/d
  • Medical conditions or medications that could influence vitamin D metabolism
  • History of kidney stones
  • Hypercalcaemia
  • Hyperparathyroidism
  • Significant liver and renal disease (liver function tests >3x upper limit of normal and glomerular filtration rate <30ml/min)

Treatment and study plan

Vitamin D3 Supplementation

Dietary Supplement

3000IU (75µg) vitamin D3 will be given daily for a period of 26 weeks to the group who receive the active comparator. The efficacy of vitamin D3 supplementation on insulin resistance will be compared to the placebo group.

Primary outcomes

  1. Change in Insulin Resistance

    Time frame: Measured at baseline and after 6 months

    Insulin resistance will be measured using the gold standard euglycaemic-hyperinsulinaemic clamp method (note - it is anticipated that a total of 60 volunteers will complete the primary endpoint assessment).

Secondary outcomes

  1. Change in Vitamin D Status

    Time frame: Measured at baseline and after 6 months

    Change in vitamin D status will be measured using the gold standard Ultra performance liquid chromatography followed by tandem mass spectrometry

  2. Change in Markers of Cardiovascular Risk

    Time frame: Measured at baseline and after 6 months

    Measurements of seated and 24-hour ambulatory blood pressure, lipids, homeostasis model assessment (HOMA), HbA1c, and inflammatory and immune function markers including tumour necrosis factor-alpha and high sensitivity c-reactive protein

  3. Change in Carotid-femoral Pulse Wave Velocity (PWV)

    Time frame: Measured at baseline and after 6 months

    Assessed by sequential tonometry with ECG gating using the SphygmoCor PWV System

  4. Change in Hand Grip Strength

    Time frame: Measured at baseline and after 6 months

    Assessed using hand held dynamometer

  5. Health Status

    Time frame: Measured at baseline and after 6 months

    SF-36 Questionnaire

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Health and Social Care Research and Development , Northern Ireland
  • Northern Ireland Chest Heart and Stroke
  • Royal Victoria Hospital, Belfast

Registry information

Official study title

Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors in People at High Risk of Type 2 Diabetes and Cardiovascular Disease (The DIR Study)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 28, 2013
Registry last updated
May 6, 2023

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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