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

NCT03029546 | Completed DMC

• 1 other identifier: 2015H0236
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• Concentration of advanced glycation end products in maternal serum following the glucose load

  biomarker

  1 hour following glucose load

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women in the 2nd trimester eligible for gestational diabetes screening.

You may qualify if:

• 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.
• pregnant women presenting for follow-up diabetes screen with 100g glucose load.
• \. 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.

You may not qualify if:

• Non-English-speaking subjects will be excluded due to inability to appropriately consent.
• Non-pregnant patients will be excluded since this is a study of maternal tissues and pregnancy outcomes related to exposures in pregnancy.
• Men will be excluded since this is a study that includes pregnant women only by nature of the research.
• Prisoners will be excluded to avoid any potential for coercion
• Minors under 18 years of age will be excluded due to lack of ability to consent without a legal guardian.
• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Jones ML, Buhimschi IA, Zhao G, Bartholomew A, Smith-Timms J, Rood KM, Buhimschi CS. Acute Glucose Load, Inflammation, Oxidative Stress, Nonenzymatic Glycation, and Screening for Gestational Diabetes. Reprod Sci. 2020 Aug;27(8):1587-1594. doi: 10.1007/s43032-020-00188-5.

  PMID: 32430709 DERIVED

• Jones ML, Buhimschi IA, Zhao G, Bartholomew A, Smith-Timms J, Rood KM, Buhimschi CS. Acute Glucose Load, Inflammation, Oxidative Stress, Nonenzymatic Glycation, and Screening for Gestational Diabetes. Reprod Sci. 2019 Feb 27:1933719119831772. doi: 10.1177/1933719119831772. Online ahead of print.

  PMID: 30813845 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catalin Buhsimchi, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 24, 2017
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2019
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)