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

Insulin Sensitivity Clinical Trial

— VitD2014  

Official title:

Vitamin D, Inflammation, and Relations to Insulin Resistance in Morbidly Obese Pre-Menopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169050
• Other study ID #: 2010-1010
• Status: Completed
• Start date: May 2011
• Est. completion date: February 2013

Study information

• Verified date: January 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance
• Insulin Sensitivity

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Glucose Insulin Sensitivity (OGIS)	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.	2 hour, 1-5 weeks before bariatric surgery
Secondary	Adipose tissue mRNA Expression of Vitamin D Receptors and Inflammation Markers		10-20 minutes, during bariatric surgery
Secondary	Inflammatory markers in plasma	Fasting blood drawn on Oral Glucose Tolerance Test day, which is 1-5 weeks before bariatric surgeries	3-15 minutes, 1-5 weeks before bariatric surgery