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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 35 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Istituto di Neuroscienze Consiglio Nazionale delle Ricerche Research network |
| Locations | 3 sites (Vienna and 2 other locations) |
| Status | Recruiting |
| Started | May 28, 2025 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT06876090 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
- Study coordinator: Andrea Tura
- Email: andrea.tura@cnr.it
- Phone: +390498295786
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes
This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.
-
Leg vs Arm Ergometer Exercise for Gestational Diabetes
This study tests whether leg-ergometer exercise helps control blood sugar and reduce stress more than arm-ergometer exercise in pregnant people with gestational diabetes.
-
Using routine blood and urine sugar tests to predict gestational diabetes after bariatric surgery
This project will test whether routine fasting and post-meal blood glucose, HbA1c, and urine glucose can help find gestational diabetes in pregnant women who previously had bariatric surgery.
-
Exploring the links between sleep hygiene, muscle loss, and brain function in lung disease
This study looks at how good or bad sleep affects muscle loss and brain function in people with lung diseases like COPD and IPF.
-
Sarcopenia in Patients After Cardiac Surgery
This observational study tests how common sarcopenia is after cardiac surgery and whether current care helps improve muscle mass and function.
-
Bone marrow mesenchymal stem cell injection for sarcopenia
This study tests whether CG-BM1, a stem cell injection, can be safely given to adults with sarcopenia to see if it helps improve muscle health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.