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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01889810
Other study ID # QUB: B12/35; HSC: 12117MMcK-AS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2013
Est. completion date June 2016

Study information

Verified date June 2022
Source Queen's University, Belfast
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Dietary Supplement:
Vitamin D3 supplementation
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.

Locations

Country Name City State
United Kingdom Queen's University, Belfast Belfast N. Ireland

Sponsors (4)

Lead Sponsor Collaborator
Queen's University, Belfast HSC Research & Development Division, Public Health Agency, Northern Ireland, Northern Ireland Chest Heart and Stroke, The Metabolic Unit Research Fund, The Royal Hospitals, Belfast, Northern Ireland

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Wallace HJ, Holmes L, Ennis CN, Cardwell CR, Woodside JV, Young IS, Bell PM, Hunter SJ, McKinley MC. Effect of vitamin D3 supplementation on insulin resistance and beta-cell function in prediabetes: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2019 Nov 1;110(5):1138-1147. doi: 10.1093/ajcn/nqz171. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Insulin Resistance 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). Measured at baseline and after 6 months
Secondary Change in Vitamin D Status Change in vitamin D status will be measured using the gold standard Ultra performance liquid chromatography followed by tandem mass spectrometry Measured at baseline and after 6 months
Secondary Change in Markers of Cardiovascular Risk 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 Measured at baseline and after 6 months
Secondary Change in Carotid-femoral Pulse Wave Velocity (PWV) Assessed by sequential tonometry with ECG gating using the SphygmoCor PWV System Measured at baseline and after 6 months
Secondary Change in Hand Grip Strength Assessed using hand held dynamometer Measured at baseline and after 6 months
Secondary Health Status SF-36 Questionnaire Measured at baseline and after 6 months
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