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

NCT01889810 | Completed Results

• 1 other identifier: QUB: B12/35; HSC: 12117MMcK-AS
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sub-optimal Vitamin D Status; Pre-diabetes; Insulin Resistance

Keywords

Vitamin D, Pre-diabetes, Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Vitamin D Status

  Measured at baseline and after 6 months

• Change in Markers of Cardiovascular Risk

  Measured at baseline and after 6 months

• Change in Carotid-femoral Pulse Wave Velocity (PWV)

  Measured at baseline and after 6 months

• Change in Hand Grip Strength

  Measured at baseline and after 6 months

• Health Status

  Measured at baseline and after 6 months

Study Arms (2)

Vitamin D3 supplementation

ACTIVE COMPARATOR

Patients will take 3000IU (75 µg) Vitamin D3 supplementation per day for a period of 26 weeks.

Dietary Supplement: Vitamin D3 supplementation

Placebo

PLACEBO COMPARATOR

Placebo group

Dietary Supplement: Vitamin D3 supplementation

Interventions

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.

Placebo; Vitamin D3 supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Health and Social Care Research and Development , Northern Ireland: collaborator
• Royal Victoria Hospital, Belfast: collaborator
• Northern Ireland Chest Heart and Stroke: collaborator

Study Sites (1)

Queen's University, Belfast

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

Location

Related 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.

  PMID: 31559433 BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Results Point of Contact

• Title: Professor Michelle McKinley
• Organization: Queen's University, Belfast

m.mckinley@qub.ac.uk

02890978936

Study Officials

• Michelle McKinley, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, Nutrition & Metabolism Research Group, Centre for Public Health

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: June 28, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2022-06

Locations

GB (1)