Viewing Study NCT00491322



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Last Modification Date: 2024-10-26 @ 9:34 AM
Study NCT ID: NCT00491322
Status: COMPLETED
Last Update Posted: 2018-05-02
First Post: 2007-06-22

Brief Title: Vitamin D Deficiency Insulin Resistance and FGF-23
Sponsor: Massachusetts General Hospital
Organization: Massachusetts General Hospital

Study Overview

Official Title: Impact of Vitamin D Deficiency on Insulin Resistance and the Regulation of FGF-23
Status: COMPLETED
Status Verified Date: 2018-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this project is to determine if treating vitamin D deficiency decreases insulin resistance and improves insulin secretion in healthy volunteers Additionally this project will investigate if treating vitamin D deficiency affects a new phosphate-regulating hormone called FGF-23
Detailed Description: Vitamin D deficiency or hypovitaminosis D defined as serum 25 hydroxyvitamin D or 20 ngmL is prevalent in several populations in the United States specifically minorities and the elderly Causes of vitamin D deficiency include lack of exposure to sunlight malnutrition and drugs that alter vitamin D metabolism and absorption

Vitamin D is an essential factor for many organ systems Data suggest that vitamin D is required for normal insulin secretion by the pancreas Specifically animal studies demonstrate that treatment of vitamin D deficiency improves insulin secretion In humans there is less consensus about the impact of vitamin D deficiency on insulin resistance In one study of middle-aged patients with Type 2 diabetes mellitus no association was seen between serum 25 hydroxyvitamin D levels and a measure of insulin resistance However in a larger study of younger glucose tolerant subjects serum 25 hydroxyvitamin D levels were associated with both insulin secretion and insulin resistance These data suggest that treatment of vitamin D deficiency may delay or prevent the development of insulin resistance and thus diabetes mellitus type 2 Repletion of this common vitamin deficiency could therefore have major public health implications for the prevention of diabetes mellitus

Fibroblast growth factor 23 FGF-23 is a newly discovered phosphaturic hormone that is regulated by both dietary and serum phosphate Hormonal regulation of FGF-23 however is largely unknown Recent data suggest that vitamin D plays an important role in the regulation of FGF-23 Some groups have shown that inactivation of the vitamin D receptor gene decreases serum FGF-23 levels in mice administration of 125 dihydroxyvitamin D stimulates the transcription of the FGF-23 gene in vitro Little is known however about the regulation of FGF-23 by vitamin D in humans

Phosphate is critical for bone mineralization muscle function signal transduction and the creation and utilization of energy Vitamin D deficiency can result in phosphate malabsorption osteomalacia and increased risk of fractures Enhanced understanding of the regulation of this new phosphate-regulating hormone FGF-23 will advance the field of phosphate metabolism

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
K23DK073356 NIH None httpsreporternihgovquickSearchK23DK073356