Clinical trial NCT04617405: Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders.
Official title: Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Gestational Diabetes
Overweight and Obesity
Pregnancy in Diabetic
Insulin Resistance
Insulin Sensitivity
Pregnancy, High Risk
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Aalborg University Hospital
name: Odense University Hospital
name: The University of Queensland
First posted: 2020-11-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consist of pregnant women followed at The Department of Gynaecology and Obstetrics at Aarhus University Hospital, Aalborg University Hospital or Odense University Hospital. Cases are either healthy with a BMI \>= 25, diagnosed with gestational diabetes before gestational week 20 or diagnosed with pregestational type 2 diabetes. Controls are healthy with a BMI \< 25.

Brief summary: The first aim of this study is to describe maternal hormonal and inflammatory changes during pregnancy in women that differ metabolically (limited to women with type 2 diabetes, gestational diabetes and/or overweight). The second aim of this study is to examine maternal hormonal, inflammatory and metabolic factors associated with insulin sensitivity in human pregnancy.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women at The Department of Gynaecology and Obstetrics at Aarhus University Hospital, Aalborg University Hospital or Odense University Hospital.
* 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:

* Age \< 18 years
* Not able to read and understand danish
* Previous bariatric surgery
* Treatment with systemic corticosteroids

Primary outcomes:
measure: Changes from baseline in serum or plasma concentration of metabolic, hormonal and inflammatory markers at four other times during pregnancy.
timeFrame: Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
measure: Assocation between the serum or plasma concentration of metabolic, hormonal and inflammatory markers Versus Insulin sensitivity at five times during pregnancy.
timeFrame: Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
measure: Changes from baseline in the level, content and bioactivity of exosomes in serum and plasma at four other times during pregnancy.
timeFrame: Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
measure: Association between the level, content and bioactivity of exosomes in serum and plasma Versus Insulin sensitivity at five times during pregnancy.
timeFrame: Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
Secondary outcomes:
measure: Changes from baseline in blood pressure (systolic and diastolic) at four other times during pregnancy.
timeFrame: Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
measure: Changes from baseline in body weight at four other times during pregnancy.
timeFrame: Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
measure: Association between the blood pressure (systolic and diastolic) Versus Insulin sensitivity at five times during pregnancy.
timeFrame: Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
measure: Association between the body weight Versus Insulin sensitivity at five times during pregnancy.
timeFrame: Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Aarhus N
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aarhus University, Aarhus University Hospital
name: Anna S Koefoed, M.D.
role: PRINCIPAL_INVESTIGATOR
References: