Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders.

Recruiting

• Conditions: Insulin Sensitivity; Pregnancy, High Risk; Diabetes Mellitus, Type 2; Gestational Diabetes; Insulin Resistance; Overweight and Obesity; Pregnancy in Diabetic
• Interventions: Other: No interventions

• Registration Number: NCT04617405
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Study Start: 2021-01-11
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-23
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type A	No interventions	Healthy normal-weight pregnant women
Type B	No interventions	Pregnant women with gestational diabetes diagnosed at early screening (before gestational week 20)
Type D	No interventions	Healthy overweight pregnant women
Type C	No interventions	Pregnant women with type 2 diabetes

Primary Outcome Measures

Name	Time	Method
Changes from baseline in the level, content and bioactivity of exosomes in serum and plasma at four other times during pregnancy.	Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38	Exosomes will be isolated and profiling of the content will be performed using SWATH mass spectrometry and miRNA sequencing.
Changes from baseline in serum or plasma concentration of metabolic, hormonal and inflammatory markers at four other times during pregnancy.	Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38	Serum concentration of IGF-1, IGFBP-3, IGFBP-1, FGF-21, Leptin, Adiponectin, CD163, Human Chorionic Gonadotropin, Progesterone, C-peptide, Cortisol, Prolactin, Sex Hormone Binding Globulin, Estradiol, Free fatty acids, Human Placental Lactogen and Human Placental Growth Hormone.; Plasma concentrations of IL-6, IL-10, IL-1alpha, IFN-gamma, TNF-alpha, ICAM1, VCAM, LDL, HDL, Triglyceride, Gamma-Glutamyl Transferase, Thyrotropin, glucose and HbA1c.
Assocation between the serum or plasma concentration of metabolic, hormonal and inflammatory markers Versus Insulin sensitivity at five times during pregnancy.	Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38	Association between the metabolic, hormonal and inflammatory markers listed as Primary Outcome 1 and the Insulin sensitivity. Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.
Association between the level, content and bioactivity of exosomes in serum and plasma Versus Insulin sensitivity at five times during pregnancy.	Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38	Exosomes will be isolated and profiling of the content will be performed using SWATH mass spectrometry and miRNA sequencing. Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.

Secondary Outcome Measures

Name	Time	Method
Association between the blood pressure (systolic and diastolic) Versus Insulin sensitivity at five times during pregnancy.	Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38	Blood pressure includes the measurement of both systolic and diastolic blood pressure (mmHg). Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.
Changes from baseline in body weight at four other times during pregnancy.	Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38	Body weight measured in kilograms.
Association between the body weight Versus Insulin sensitivity at five times during pregnancy.	Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38	Body weight measured in kilograms. Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.
Changes from baseline in blood pressure (systolic and diastolic) at four other times during pregnancy.	Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38	Blood pressure includes the measurement of both systolic and diastolic blood pressure (mmHg).

Trial Locations

Locations (3)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Aarhus N, Denmark