Skip to main content
OpenTrials
Completed

NCT Number: NCT01692028

Identification of the Region of Vitamin D Responsiveness

Hypothesis: low vitamin D status is associated with increased insulin resistance and increased blood pressure.

Approach: Multiple regression analysis of information extracted from a large database accumulated by a Canadian health foundation, specifically evaluating statistical associations between serum 25(OH)D levels and insulin responsiveness measures as well as blood pressure, after adjusting these variables for BMI, age, sex, and waist circumference.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pure North S'Energy Foundataion

Calgary, Alberta, Canada

About this study

Data obtained from the entry records of 4,116 adult men and women in Calgary,Alberta previously enrolled in the Pure North S'Energy Foundation's health program. Individuals with a clinical diagnosis of diabetes mellitus or a HOMA-IR value above 16 were excluded. Standard statistical analyses carried out. An association between 25(OH)D and the endpoints of interest was first established. The residual values after adjusting HOMA-IR, serum insulin, QUICKI, and blood pressure for BMI, age, sex, and waist circumference were then regressed against serum 25(OH)D using 40-percentile data blocks, stepping upward from the lowest 25(OH)D values by 5 percentile increments through the 7th decile. Regression coefficients are then computed for each data block and each outcome variable. The location (along the 25(OF)D continuum) of the largest and most statistically significant coefficients is noted, and regions of null response noted as well.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18

Exclusion criteria

  • Diabetes
  • Elevated HOMA-IR (>16)

Treatment and study plan

Primary outcomes

  1. HOMA-IR

    Time frame: Observational/cross-sectional study

    A composite measure of insulin resistance (HOMA-IR)

Secondary outcomes

  1. Blood pressure

    Time frame: cross-sectional study

    Blood Pressure

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Official study title

A Novel Approach Localizes the Association of Vitamin D Status With Insulin Resistance to One Region of the 25(OH)D Continuum.

Acronym: GRH-PN01

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 25, 2012
Registry last updated
Sep 25, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.