Clinical trial Recruiting at 2 sites Observational Ages 35 and up Women only

Muscle loss in pregnant women with gestational diabetes.

Official title: Sarcopenia in Gestational Diabetes: The SiGnal-D Study

Run by Istituto di Neuroscienze Consiglio Nazionale delle Ricerche · NCT06876090 · Data updated 2026-11-12

This project will test whether pregnant women with gestational diabetes show signs of muscle loss (sarcopenia) and whether those muscle measures relate to pregnancy outcomes and thinking skills.

More Sarcopenia trials

Quick facts

Study typeObservational
Ages35 Years and up
SexWomen only
Enrollment200 (estimated)
SponsorIstituto di Neuroscienze Consiglio Nazionale delle Ricerche
Research network
Locations3 sites (Vienna and 2 other locations)
StatusRecruiting
StartedMay 28, 2025
Main results expectedApril 2026
Study endsApril 2026
Registry record updatedNovember 21, 2025
Trial IDNCT06876090 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are pregnant women who meet at least one risk criterion (age ≥35, BMI ≥25 kg/m², borderline high fasting glucose, prior fetal macrosomia or GDM, or a first-degree family history of diabetes) and who do not have preexisting diabetes or conditions affecting muscle.

Probably not a fit

Women with twin pregnancies, known type 1 or type 2 diabetes, neurological or psychiatric diseases, or other disorders that affect muscle mass or function are not eligible and are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project enrolls pregnant women at risk for gestational diabetes and performs sarcopenia tests (muscle mass, strength, and physical performance), an oral glucose tolerance test (OGTT), and the Montreal Cognitive Assessment (MoCA). Muscle measures will be compared with glucose tolerance results, pregnancy outcomes, and cognitive screening scores. Women with twin pregnancies, known diabetes, neurological/psychiatric disease, or other conditions affecting muscle are excluded. Recruitment and testing occur at centers in Vienna, Padova, and Pisa to determine whether sarcopenia occurs in gestational diabetes and whether it links to adverse maternal, neonatal, or cognitive outcomes.

Why it matters

Potential benefit: If successful, results could support earlier recognition of muscle loss in pregnant women with GDM and guide interventions to reduce adverse maternal and neonatal outcomes.

How similar studies have gone: Prior work has found links between sarcopenia and type 2 diabetes and between sarcopenia and cognitive impairment, but sarcopenia specifically in gestational diabetes has been largely untested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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.

Exclusion Criteria:

* Unmatching of at least one among the inclusion criteria;
* Twin pregnancy;
* Presence of any already known disease/disorder possibly affecting muscle mass or function;
* Neurological or psychiatric diseases;
* Already known diabetes (e.g., type 1 or type 2 diabetes).

Where it's running

  • Department of Obstetrics and Gynaecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Vienna
    Vienna, Austria
    Recruiting
  • Department of Clinical and Experimental Medicine, University of Pisa
    Pisa, Pi, Italy
    Recruiting
  • Institute of Neuroscience, National Research Council
    Padova, Pd, Italy
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.