Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders.
NCT ID: NCT04617405
Last Updated: 2022-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2021-01-11
2023-12-31
Brief Summary
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Detailed Description
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The study includes 50 healthy normal-weight women, 150 healthy overweight women, 50 women with gestational diabetes and 50 women with type 2 diabetes.
Hormonal profiles and inflammatory markers will be measured at gestational week 8-10, 10-14, 18-22, 24-28 and 34-38. The blood samples will include HbA1c, glukose, insulin, C-peptid, lipid profile, liver enzymes, creatinine, FGF-21, TSH, Cortisol, human chorionic gonadotropin, estradiol, progesterone, prolactin, human placental lactogen, placental growth hormone, IGF-1, IGF-BP's, Leptin, Adiponectin, GLP-1, GIP, hs-CRP, IL-6, IL-10, IL-1α, IFN-ɣ, TNF-α, ICAM1, VCAM and CD163. In addition to this, exosomes will be isolated precisely and profiling of the content of exosomes will be performed using in vitro assays. Proteomics and miRNAs sequencing will be employed.
Height, weight, and blood pressure will be measured at every visit and a urine sample will be collected.
Insulin sensitivity will be estimated using the homeostasis model assessment, IS-HOMA, based on fasting insulin and glucose concentrations.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Type A
Healthy normal-weight pregnant women
No interventions
No interventions
Type B
Pregnant women with gestational diabetes diagnosed at early screening (before gestational week 20)
No interventions
No interventions
Type C
Pregnant women with type 2 diabetes
No interventions
No interventions
Type D
Healthy overweight pregnant women
No interventions
No interventions
Interventions
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No interventions
No interventions
Eligibility Criteria
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Inclusion Criteria
* Women have to be in 1 of 4 categories: Healthy with a BMI \< 25, healthy with a BMI \>= 25, diagnosed with gestational diabetes before gestational week 20 or diagnosed with pregestational type 2 diabetes
Exclusion Criteria
* Not able to read and understand danish
* Previous bariatric surgery
* Treatment with systemic corticosteroids
18 Years
FEMALE
No
Sponsors
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Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Odense University Hospital
OTHER
The University of Queensland
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Anna S Koefoed, M.D.
Role: PRINCIPAL_INVESTIGATOR
Aarhus University, Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, Aarhus N, Denmark
Aalborg University Hospital
Aalborg, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PADME1
Identifier Type: -
Identifier Source: org_study_id
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