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

NCT02169050 | Completed DMC

• 1 other identifier: 2010-1010
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity

Keywords

Vitamin D deficiency; Inflammation; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

No intervention

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

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects are drawn from women seeking surgical treatment for their morbid obesity at the University of Illinois at Chicago Medical Center (UICMC) Bariatric surgery clinics.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Adipose tissues

MeSH Terms

Conditions

Insulin Resistance; Vitamin D Deficiency; Inflammation; Obesity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Body Weight; Signs and Symptoms

Study Officials

• Carol Braunschweig, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: May 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

US (1)