Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders. (HI-MET)

University of Aarhus

Status: Enrolling

Conditions: Gestational Diabetes; Pregnancy in Diabetic; Insulin Resistance; Overweight and Obesity; Pregnancy, High Risk; Diabetes Mellitus, Type 2; Insulin Sensitivity

Treatments: Other: No interventions

Study type: Observational

Funder types: Other

Identifiers

NCT04617405

PADME1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 4 patient groups

Type A

Description:

Healthy normal-weight pregnant women

Treatment:

Other: No interventions

Type B

Description:

Pregnant women with gestational diabetes diagnosed at early screening (before gestational week 20)

Treatment:

Other: No interventions

Type C

Description:

Pregnant women with type 2 diabetes

Treatment:

Other: No interventions

Type D

Description:

Healthy overweight pregnant women

Treatment:

Other: No interventions