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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02169050
First Posted: June 20, 2014
Last Update Posted: June 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Illinois at Chicago
  Purpose
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.

Condition
Insulin Sensitivity

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Months
Official Title: Vitamin D, Inflammation, and Relations to Insulin Resistance in Morbidly Obese Pre-Menopausal Women

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Oral Glucose Insulin Sensitivity (OGIS) [ Time Frame: 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:
  • Adipose tissue mRNA Expression of Vitamin D Receptors and Inflammation Markers [ Time Frame: 10-20 minutes, during bariatric surgery ]
  • Inflammatory markers in plasma [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Plasma Adipose tissues

Enrollment: 76
Study Start Date: May 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No intervention
There is no intervention to subjects in this study. All subjects are morbidly women seeking bariatric surgeries.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169050


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Carol Braunschweig, PhD University of Illinois at Chicago
  More Information

Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02169050     History of Changes
Other Study ID Numbers: VitD2014
First Submitted: June 18, 2014
First Posted: June 20, 2014
Last Update Posted: June 20, 2014
Last Verified: June 2014

Keywords provided by University of Illinois at Chicago:
Vitamin D deficiency
Inflammation
Obesity

Additional relevant MeSH terms:
Inflammation
Insulin Resistance
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents