Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 2
- Gestational Diabetes
- Insulin Resistance
- Insulin Sensitivity
- Overweight and Obesity
- Pregnancy in Diabetic
- Pregnancy, High Risk
- Type
- Observational
- Design
- Observational Model: Case-ControlTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
This is a prospective observational study including app. 300 pregnant women from the outpatient clinics at Department of Obstetrics and Gynecology at Aalborg, Odense and Aarhus University Hospital. The study includes 50 healthy normal-weight women, 150 healthy overweight women, 50 women with gestati...
This is a prospective observational study including app. 300 pregnant women from the outpatient clinics at Department of Obstetrics and Gynecology at Aalborg, Odense and Aarhus University Hospital. 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-1?, IFN-?, TNF-?, 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.
Tracking Information
- NCT #
- NCT04617405
- Collaborators
- Aarhus University Hospital
- Aalborg University Hospital
- Odense University Hospital
- The University of Queensland
- Investigators
- Principal Investigator: Anna S Koefoed, M.D. Aarhus University, Aarhus University Hospital