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

Completed

• Conditions: Insulin Sensitivity

• Registration Number: NCT02169050
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral Glucose Insulin Sensitivity (OGIS)	2 hour, 1-5 weeks before bariatric surgery	Insulin sensitivity is assessed based with a 2-hour, 75gm Oral Glucose Tolerance Test. Blood samples are collected at 0, 90, and 120 min for the measurement of glucose and insulin.

Secondary Outcome Measures

Name	Time	Method
Adipose tissue mRNA Expression of Vitamin D Receptors and Inflammation Markers	10-20 minutes, during bariatric surgery
Inflammatory markers in plasma	3-15 minutes, 1-5 weeks before bariatric surgery	Fasting blood drawn on Oral Glucose Tolerance Test day, which is 1-5 weeks before bariatric surgeries

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States