Association Between Vitamin D and Inflammation and Diabetes Risk in Morbidly Obese Pre-Menopausal Women

NCT ID: NCT02169050

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-02-28

Brief Summary

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Obesity is associated with low-grade inflammation, insulin resistance and low vitamin D status. Vitamin D has traditionally been known to involve in calcium homeostasis and prevent rickets; however, recently it has been recognized to inversely associate with many non-skeletal diseases and conditions including obesity and type 2 diabetes (T2DM). In vitro studies have demonstrated that vitamin D possesses anti-inflammatory properties. It remains unknown if the effect of vitamin D on insulin sensitivity is mediated by suppressing inflammation in human adipose tissues. The main objective of this study was to assess the association between vitamin D and insulin sensitivity and inflammation in morbidly obese pre-menopausal women. Obese women (n=76) were recruited from the University of Illinois at Chicago (UIC) Nutrition and Wellness Center and the UIC medical center bariatric surgery clinics. Insulin sensitivity/resistance was assessed by (1) Oral glucose insulin sensitivity (OGIS) index, derived from dynamic oral glucose tolerance test (OGTT), and (2) Homeostasis model of insulin resistance (HOMA-IR), calculated from fasting steady-state glucose and insulin. Also, to better understand the potential mechanism and the role circulating vitamin D (25OHD) plays in adipose tissue inflammation, we assessed messenger ribonucleic acid (mRNA) expression of vitamin D receptor (VDR) and various inflammatory genes in visceral (VAT) and subcutaneous adipose tissues (SAT) of obese women that underwent a restrictive bariatric procedure. We hypothesized that subjects with higher serum vitamin D levels would be less inflamed and more insulin sensitive and have increased expression of VDR and pro-inflammatory markers compared to those with lower serum vitamin D levels.

Detailed Description

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Conditions

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Insulin Sensitivity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No intervention

There is no intervention to subjects in this study. All subjects are morbidly women seeking bariatric surgeries.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Premenopausal women between the age of 21 and 49 years old
* BMI \>=35(kg/m2)
* Not pregnant
* English speaking
* Approved for a bariatric surgery

Exclusion Criteria

Subjects with:

* Diabetes
* Cancer
* Kidney disease
* Liver disease
* Gallbladder disease
* Rheumatoid arthritis
* HIV/AIDS
* Crohn's disease or inflammatory bowel disease
* Subjects taking anti-inflammatory medications
Minimum Eligible Age

21 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol Braunschweig, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2010-1010

Identifier Type: -

Identifier Source: org_study_id

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