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Effect of Glucose Load on Expression of Advanced Glycation End Products in Women Screened for Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT03029546
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The investigator's main objective is to analyze the effects of a routine prenatal care screening tool (glucola test for gestational diabetes) on maternal inflammation through assessment of maternal circulatory biomarkers and blood pressure. Improving knowledge about routine prenatal care and how a variety of screening factors affect maternal physiology allows the investigators to be educated and informed when caring for mothers with medical co-morbidities.

  • Determine if an acute glucose load (50g) is associated with an in-vivo and in-vitro increase in the concentration of Advanced Glycation End Products (AGEP's) that, in turn, can impact vascular endothelial reactivity and induce an acute increase in blood pressure. Previous studies generated in the investigators' laboratory showed that circulating soluble Receptor for Advanced Glycation End Products (sRAGE) and Tumor Necrosis Factor (TNF)-a (mediator of acute inflammation) are considered markers of the extent of maternal RAGE activation and/or systemic inflammation, respectively.
  • Determine how an acute glucose load (50g) at the time of normal screening for gestational diabetes induces an acute increase in the level of sRAGE and TNF-a. If the investigators' hypothesis is confirmed, the investigators will have strong confirmation of the involvement of glycation products and TNF-a in generating the acute negative clinical symptoms of women experiencing a glucose tolerance test, such as headache, nausea, sweating, and bloating.

Condition or disease
Inflammation

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Effect of Acute Glucose Loading on Level of Expression of Advanced Glycation End Products in Women Screened for Gestational Diabetes During Pregnancy
Study Start Date : November 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Glucose load

50 subjects undergoing routine gestational diabetes screen with 50g glucose load.

5 subjects undergoing follow-up gestational diabetes screen with 100g glucose load.

Control
50 subjects undergoing water ingestion with the same study measurements as the glucose load group at the same time intervals.


Outcome Measures

Primary Outcome Measures :
  1. Concentration of advanced glycation end products in maternal serum following the glucose load [ Time Frame: 1 hour following glucose load ]
    biomarker


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women in the 2nd trimester eligible for gestational diabetes screening.
Criteria

Inclusion Criteria:

  1. 50 pregnant women in the high risk clinic presenting for diabetes screen with 50g glucose load at a routine prenatal visit will be recruited for enrollment.
  2. 5 pregnant women presenting for follow-up diabetes screen with 100g glucose load.

2. 50 healthy pregnant women in the general obstetric clinic at McCampbell Hall will be recruited as controls to ingest a 50cc sample of water and undergo identical objective measurements (blood pressure measurements and urine/ blood samples) as the glucose loading subjects.

Exclusion Criteria:

  1. Non-English-speaking subjects will be excluded due to inability to appropriately consent.
  2. Non-pregnant patients will be excluded since this is a study of maternal tissues and pregnancy outcomes related to exposures in pregnancy.
  3. Men will be excluded since this is a study that includes pregnant women only by nature of the research.
  4. Prisoners will be excluded to avoid any potential for coercion
  5. Minors under 18 years of age will be excluded due to lack of ability to consent without a legal guardian.
  6. Patients with contra-indications to glucola testing for gestational diabetes screening will be excluded, such as bariatric surgery, inflammatory bowel disease with partial bowel resection, and other mal-absorptive conditions.
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): NCT03029546


Contacts
Contact: Megan L Jones, MD 913-961-1915 megan.jones2@osumc.edu
Contact: Catalin Buhimschi, MD 614-293-9217 catalin.buhsimchi@osumc.edu

Locations
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Megan L Jones, MD    913-961-1915    megan.jones2@osumc.edu   
Contact: Catalin Buhimschi, MD    614-293-9217    catalin.buhimschi@osumc.edu   
Sponsors and Collaborators
Ohio State University
Nationwide Children's Hospital
Investigators
Principal Investigator: Catalin Buhsimchi, MD Ohio State University
More Information

Responsible Party: Buhimschi, Catalin S, MD, Principle Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT03029546     History of Changes
Other Study ID Numbers: 2015H0236
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Inflammation
Diabetes, Gestational
Pathologic Processes
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases