Insulin SensitivityVitD2014NCT02169050
Association Between Vitamin D and Inflammation and Diabetes Risk in Morbidly Obese Pre-Menopausal Women
An observational study of Insulin Sensitivity, run by University of Illinois Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 49 years, women only
- Conditions the study is for
- Insulin Sensitivity
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Feb 2013
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 49 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Premenopausal women between the age of 21 and 49 years old
- BMI >=35(kg/m2)
- Not pregnant
- English speaking
- Approved for a bariatric surgery
Who cannot join
- Subjects with:
- Diabetes
- Cancer
- Kidney disease
- Liver disease
- Gallbladder disease
Show all 10Show fewer
- Rheumatoid arthritis
- HIV/AIDS
- Crohn's disease or inflammatory bowel disease
- Subjects taking anti-inflammatory medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Vitamin D, Inflammation, and Relations to Insulin Resistance in Morbidly Obese Pre-Menopausal Women
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
- Medical subject headings
- Insulin Resistance, Vitamin D Deficiency, Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | There is no intervention to subjects in this study. All subjects are morbidly women seeking bariatric surgeries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hour, 1-5 weeks before bariatric surgery
Secondary outcomes (2)
Adipose tissue mRNA Expression of Vitamin D Receptors and Inflammation Markers
Measured: 10-20 minutes, during bariatric surgery
Inflammatory markers in plasma
Fasting blood drawn on Oral Glucose Tolerance Test day, which is 1-5 weeks before bariatric surgeries
Measured: 3-15 minutes, 1-5 weeks before bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol Braunschweig, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169050
- Sponsor's protocol ID
- 2010-1010
- Acronym
- VitD2014
- Status last verified
- Jan 2020
- First submitted
- 18 Jun 2014
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D, Inflammation, and Relations to Insulin Resistance in Morbidly Obese Pre-Menopausal Women
- ClinicalTrials.gov ID
- NCT02169050
- Acronym / sponsor ID
- VitD2014 / 2010-1010
- Conditions
- Insulin Sensitivity
- Keywords
- Vitamin D deficiency, Inflammation, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No intervention | – | –There is no intervention to subjects in this study. All subjects are morbidly women seeking bariatric surgeries. |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- Premenopausal women between the age of 21 and 49 years old
- BMI >=35(kg/m2)
- Not pregnant
- English speaking
- Approved for a bariatric surgery
Key exclusion criteria (10 listed)
- Diabetes
- Cancer
- Kidney disease
- Liver disease
- Gallbladder disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Related trials for Insulin Sensitivity
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
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Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
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Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Braunschweig, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Sensitivity, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Glucose Insulin Sensitivity (OGIS) (time frame: 2 hour, 1-5 weeks before bariatric surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.