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

NCT04617405 | Unknown

• 1 other identifier: PADME1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Changes from baseline in serum or plasma concentration of metabolic, hormonal and inflammatory markers at four other times during pregnancy.

  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.

  Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38

• Assocation between the serum or plasma concentration of metabolic, hormonal and inflammatory markers Versus Insulin sensitivity at five times during pregnancy.

  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.

  Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38

• Changes from baseline in the level, content and bioactivity of exosomes in serum and plasma at four other times during pregnancy.

  Exosomes will be isolated and profiling of the content will be performed using SWATH mass spectrometry and miRNA sequencing.

  Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38

• Association between the level, content and bioactivity of exosomes in serum and plasma Versus Insulin sensitivity at five times during pregnancy.

  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.

  Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (4)

Type A

Healthy normal-weight pregnant women

Other: No interventions

Type B

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

Other: No interventions

Type C

Pregnant women with type 2 diabetes

Other: No interventions

Type D

Healthy overweight pregnant women

Other: No interventions

Interventions

No interventions OTHER

No interventions

Type A; Type B; Type C; Type D

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant women are eligible for participation.
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Odense University Hospital: collaborator
• The University of Queensland: collaborator

Study Sites (3)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, 9100, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes, Gestational; Overweight; Obesity; Pregnancy in Diabetics; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Study Officials

• Anna S Koefoed, M.D.

  Aarhus University, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna S Koefoed, M.D.

CONTACT

+45 93 50 80 69; annask@clin.au.dk

Per G Ovesen, Prof., M.D.

CONTACT

perovese@rm.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 5, 2020
• Study Start: January 11, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)