Muscle loss in pregnant women with gestational diabetes.
Sarcopenia in Gestational Diabetes: The SiGnal-D Study
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 35 Years and up |
| Sex | Female |
| Sponsor | Istituto di Neuroscienze Consiglio Nazionale delle Ricerche Research network |
| Locations | 3 sites (Vienna and 2 other locations) |
| Trial ID | NCT06876090 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vienna and 2 other locations
- Department of Obstetrics and Gynaecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Vienna — Vienna, Austria (Recruiting)
- Institute of Neuroscience, National Research Council — Padova, Pd, Italy (Active_not_recruiting)
- Department of Clinical and Experimental Medicine, University of Pisa — Pisa, Pi, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Tura
- Email: andrea.tura@cnr.it
- Phone: +390498295786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.