Maternal and Fetal Metabolic Changes

NCT06288126 | Completed

• 1 other identifier: MoMM-FET
• Study Type: observational
• Target: 457
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring. Primary objectives:

• measurement of maternal blood adipokine levels, during the first trimester of pregnancy, in two groups of women (high and low risk), in order to identify early markers which, in conjunction with the medical history, can identify women at increased risk of developing GDM
• ultrasound measurement of adipose tissue deposits at ectopic sites, comparing low- and high-risk women, and assessing the effect of pregnancy on these deposits.
• Identification, by targeted ultrasound assessment, of fetuses at increased risk of macrosomia. Secondary objectives:
• Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women.
• Evaluation of neonatal complications in children born to low- and high-risk mothers (need for resuscitation, hypoglycaemia, hypocalcaemia, admission to neonatal intensive care unit). The participants will be recruited during first trimester ultrasound after signing the informed consent.

Conditions

Pregnancy Related; Maternal-Fetal Relations; Metabolism Disorder, Glucose

Keywords

metabolism; insulin resistance; adipose tissue; insulin-signalling pathway

Outcome Measures

Primary Outcomes (3)

• Blood adipokine levels

  Adiponectine (ug/mL); insulin (ng/mL); C-peptide (ng/mL); leptin (ng/mL); resistin (ng/mL)

  Between 11 (+0 days) and 13 (+6 days) weeks of pregnancy (recruitment visit)

• Abdominal Fat Thickness

  Ultrasound evaluation, measures expressed in mm. Abdominal Subcutaneous Fat Thickness (ASFT): lower ASFT (thickness of ASFT at the intersection of the horizontal line between the highest points of the iliac crest and the alba line, measuring the thickness of the external face of the rectus abdominis muscle at the skin's surface, with the minimum possible pressure applied on the skin); upper ASFT (subcutaneous adipose thickness at the maximum vertical distance from the skin line to the anterior edge of the linea alba, after a mid-sagittal section of the upper maternal abdomen, with the minimum possible pressure from the probe). Visceral Abdominal Fat Thickness (VAT): adipose tissue in the anterior abdomen at the xipho-umbilical line.

  Between 11 (+0 days) and 13 (+6 days) weeks of pregnancy (recruitment visit)

• Fetal Adipose Tissue Deposits

  Ultrasound evaluation, measures expressed in mm. Thickness of subcutaneous adipose tissue in the abdomen, thigh, arm.

  Between 28 (+0 days) and 40 (+6 days) weeks of pregnancy (third trimester control visit)

Secondary Outcomes (2)

• Gestational diabetes prevalence

  Between 14 (+0 days) and 27 (+6 days) weeks of pregnancy (second trimester control visit) and third trimester control visit

• Obstetric complications and mode of delivery

  Recruitment visit; second trimester control visit; third trimester control visit; in the day of the delivery, in average 6 months after recruitment visit (post-partum visit)

Study Arms (2)

High Risk Group

This group include women at high risk for gestational diabetes (GDM) according to most of the European guidelines. They have one or more of the following criteria: age ≥35 years, overweight or obesity, family history of diabetes, high-risk ethnicities, history of previous GDM or previous macrosomia, and high levels of fasting glycemia during the first trimester screening.

Low Risk Group

This group will include women at low risk for GDM according to most of the European guidelines. They have none of the following criteria: age ≥35 years, overweight or obesity, family history of diabetes, high-risk ethnicities, history of previous GDM or previous macrosomia, and high levels of fasting glycemia during the first trimester screening.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with a singleton pregnancy attending our Centre for aneuploidies screening in the first trimester.

You may qualify if:

• singleton pregnancy
• first visit between 11 and 14 weeks of pregnancy

You may not qualify if:

• consent withdrawal
• multiple pregnancy
• prepregnancy diabetes mellitus
• women undergoing therapy with oral hypoglycaemic drugs
• previous bariatric surgery
• fetal chromosomal and/or major structural abnormalities were excluded

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal blood

MeSH Terms

Conditions

Glucose Metabolism Disorders; Insulin Resistance

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Tommaso Simoncini, MD. PhD.

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 1, 2024
• Study Start: August 1, 2019
• Primary Completion: October 9, 2020
• Study Completion: January 18, 2021
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)