Recruiting

SiGnal-DSarcopenia and Pregnancy Outcomes in Gestational Diabetes

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+15

+ Atrophy

+ Diabetes Mellitus

Over 35 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: May 2025
See protocol details

Summary

Principal SponsorIstituto di Neuroscienze Consiglio Nazionale delle Ricerche
Study ContactAndrea TuraMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 28, 2025

Actual date on which the first participant was enrolled.

This study explores the presence of sarcopenia, a condition where people lose muscle mass and strength, in women with gestational diabetes (GDM). Sarcopenia is not only a concern for older adults but can also affect younger individuals, including women of childbearing age. Researchers are investigating whether women with GDM are more likely to experience sarcopenia and how it might influence pregnancy outcomes and mental functions. Understanding these connections could help improve health strategies for pregnant women, potentially preventing complications and reducing the risk of developing type 2 diabetes in the future. Participants in this study will undergo a test called the oral glucose tolerance test (OGTT) to assess their body's glucose processing ability, focusing on insulin resistance, a known risk factor for sarcopenia. Clinical data relevant to sarcopenia will be collected to see if there is a link between this condition and GDM. By comparing women with and without GDM, researchers aim to determine how common sarcopenia is among these groups. This information could guide future interventions to prevent sarcopenia and improve pregnancy outcomes.

Official TitleSarcopenia in Gestational Diabetes: The SiGnal-D Study
NCT06876090
Principal SponsorIstituto di Neuroscienze Consiglio Nazionale delle Ricerche
Study ContactAndrea TuraMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAtrophyDiabetes MellitusEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMetabolic DiseasesMuscular AtrophyNervous System DiseasesNeurologic ManifestationsNutritional and Metabolic DiseasesPregnancy ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes, GestationalPathological Conditions, AnatomicalNeuromuscular ManifestationsGlucose Metabolism DisordersSarcopenia

Criteria

1 inclusion criteria required to participate
At least one among the following conditions: * Age equal to or higher than 35 years; * Body mass index (BMI) equal to or higher than 25 kg/m\^2; * Glycemia between 5.6 and 6.9 mmol/L before or at the beginning of pregnancy; * Fetal macrosomia in previous pregnancy; * GDM in previous pregnancy; * First-degree family history of diabetes.

5 exclusion criteria prevent from participating
Neurological or psychiatric diseases;

Unmatching of at least one among the inclusion criteria;

Twin pregnancy;

Presence of any already known disease/disorder possibly affecting muscle mass or function;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

Department of Obstetrics and Gynaecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Vienna

Vienna, AustriaOpen Department of Obstetrics and Gynaecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Vienna in Google Maps
Recruiting

Department of Clinical and Experimental Medicine, University of Pisa

Pisa, Italy
Suspended

Institute of Neuroscience, National Research Council

Padua, Italy
Recruiting
3 Study Centers
SiGnal-D | Sarcopenia and Pregnancy Outcomes in Gestational Diabetes | PatLynk