SarcopeniaSiGnal-DNCT06876090
Sarcopenia in Gestational Diabetes
An observational study of Sarcopenia and Gestational Diabetes Mellitus (GDM), run by Istituto di Neuroscienze Consiglio Nazionale delle Ricerche at 3 sites in 2 countries.
Trial summary
Sarcopenia is a syndrome characterized by loss of skeletal muscle mass and strength, and physical performance deterioration. Prevalence of sarcopenia in elderly people is remarkably high (prevalence of about 25% in 60+ years people). In type 2 diabetes (T2D), sarcopenia is emerging as comorbidity of major concern. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Sarcopenia, Gestational Diabetes Mellitus (GDM), Pregnancy Complications
- What is being tested?
- Sarcopenia tests (for muscle mass, muscle function, physical performance), Oral Glucose Tolerance Test and Montreal Cognitive Assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 May 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women, based on the inclusion and exclusion criteria as outlined above.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Italy2 sites, 1 recruiting
- Active, not recruiting
Institute of Neuroscience, National Research Council
Padova, PD, 35127
- Recruiting
Department of Clinical and Experimental Medicine, University of Pisa
Pisa, PI, 56124
Angela Dardano, +39050995146, angela.dardano@unipi.it
Angela Dardano
Austria1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynaecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Vienna
Vienna, 1090
Christian Göbl, +43 660/65 34 828, christian.gobl@meduniwien.ac.at
Christian Göbl
About this study
Official title: Sarcopenia in Gestational Diabetes: The SiGnal-D Study
Sarcopenia is a syndrome characterized by loss of skeletal muscle mass and strength, and physical performance deterioration. Prevalence of sarcopenia in elderly people is remarkably high (prevalence of about 25% in 60+ years people). In type 2 diabetes (T2D), sarcopenia is emerging as comorbidity of major concern. Sarcopenia, however, is not limited to elderly people, as it can develop also in younger individuals with prevalence around 9% or even higher according to some investigators. Of note, sarcopenia has been reported even in the 20-29 years interval. This interval includes women of childbearing age, thus raising the question whether sarcopenia may occur also in women with gestational diabetes (GDM) and whether this may affect pregnancy outcomes. Also, association between sarcopenia and cognitive impairment has been repeatedly reported, to the point that some authors have emphasized the importance of early sarcopenia recognition for prevention of cognitive impairment. Therefore, our main aims are:
- To ascertain whether sarcopenia is present in GDM and, in that case, its prevalence;
- To identify risk factors for sarcopenia;
- To determine sarcopenia impact on pregnancy outcomes, and cognitive function.
During pregnancy, all women will undergo oral glucose tolerance test (OGTT) for assessment of the glucometabolic condition. Several clinical variables of interest in sarcopenia will also be recorded. As regards the OGTT data, special focus will be on the assessment of insulin resistance, both at fasting and during the dynamic conditions determined by the OGTT. Notably, the special interest for insulin resistance is due to the reason that this type of metabolic alteration is known to be a risk factor for sarcopenia. In fact, all women will then undergo testing for diagnosis of sarcopenia (or presarcopenia), and all data and parameters will be analyzed to identify relationships between sarcopenia-related variables and GDM-related ones. It is worth noting that in consideration of the exacerbated insulin resistance condition often observed in GDM, the investigators expect indeed a not negligible prevalence of sarcopenia (or at least presarcopenia) in GDM women, despite the young (non-elderly) age. In addition, since insulin resistance is often present in pregnancy even in the absence of dysglycemia, the investigators do not exclude to identify some cases of sarcopenia/presarcopenia even in pregnant non-GDM women. This study will be the basis for future studies (also of interventional type), especially in women with GDM for prevention of sarcopenia and related possible pregnancy complication and adverse pregnancy outcomes, as well as for possibly contributing to mitigation of risk for T2D development in later life.
- Conditions
- Sarcopenia, Gestational Diabetes Mellitus (GDM), Pregnancy Complications, Adverse Maternal and Neonatal Outcomes, Cognitive Function
- Being tested
- Sarcopenia tests (for muscle mass, muscle function, physical performance), Oral Glucose Tolerance Test, Montreal Cognitive Assessment
- Medical subject headings
- Sarcopenia, Diabetes, Gestational, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcopenia tests (for muscle mass, muscle function, physical performance)Diagnostic test
We are not aware of any other study performing sarcopenia tests in GDM (or in pregnancy in general), with the aim of assessing sarcopenia prevalence in GDM/pregnancy, and related possible adverse pregnancy outcomes.
Oral Glucose Tolerance TestDiagnostic test
The OGTT, in combination with the sarcopenia tests, will allow to explore the relationships between the glucometabolic condition and the muscle quality in the pregnant women, either with GDM or with normal glucose tolerance.
Montreal Cognitive AssessmentOther
The MoCA questionnaire, in combination with the sarcopenia tests, will allow to explore the relationships between the cognitive function the presence of the sarcopenia syndrome in the pregnant women, either with GDM or with normal glucose tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabetes (GDM) women | Not described Receives: Diagnostic Test: Sarcopenia tests (for muscle mass, muscle function, physical performance); Diagnostic Test: Oral Glucose Tolerance Test; Other: Montreal Cognitive Assessment | |
| Pregnant women without gestational diabetes (non-GDM) | Not described Receives: Diagnostic Test: Sarcopenia tests (for muscle mass, muscle function, physical performance); Diagnostic Test: Oral Glucose Tolerance Test; Other: Montreal Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sarcopenia/presarcopenia in pregnant women with and without gestational diabetes
Measured: Between week 28 and week 32 of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start28 May 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
- Sponsor type
- Research network
- Collaborators
- University of Pisa, Medical University of Vienna
- Responsible party
- Principal investigator, Andrea Tura, Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876090
- Sponsor's protocol ID
- 2022XYXRJN_LS4_PRIN2022
- Other IDs
- B53D23022000006
- Acronym
- SiGnal-D
- Status last verified
- Nov 2025
- First submitted
- 3 Mar 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dardano A, Daniele G, Gobl CS, Tura A. Protocol for a prospective cohort study for the assessment of sarcopenia in gestational diabetes: the SiGnal-D study. BMJ Open. 2026 Mar 2;16(3):e106837. doi: 10.1136/bmjopen-2025-106837.
PubMed 41771588
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia in Gestational Diabetes: The SiGnal-D Study
- ClinicalTrials.gov ID
- NCT06876090
- Acronym / sponsor ID
- SiGnal-D / 2022XYXRJN_LS4_PRIN2022
- Conditions
- Sarcopenia, Gestational Diabetes Mellitus (GDM), Pregnancy Complications, Adverse Maternal and Neonatal Outcomes, Cognitive Function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto di Neuroscienze Consiglio Nazionale delle RicercheResearch network
- Collaborators
- University of Pisa, Medical University of Vienna
- Study start
- 28 May 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sarcopenia is a syndrome characterized by loss of skeletal muscle mass and strength, and physical performance deterioration. Prevalence of sarcopenia in elderly people is remarkably high (prevalence of about 25% in 60+ years people). In type 2 diabetes (T2D), sarcopenia is emerging as comorbidity of major concern. Sarcopenia, however, is not limited to elderly people, as it can develop also in younger individuals with prevalence around 9% or even higher according to some investigators. Of note, sarcopenia has been reported even in the 20-29 years interval. This interval includes women of childbearing age, thus raising the question whether sarcopenia may occur also in women with gestational diabetes (GDM) and whether this may affect pregnancy outcomes. Also, association between sarcopenia and cognitive impairment has been repeatedly reported, to the point that some authors have emphasized the importance of early sarcopenia recognition for prevention of cognitive impairment. Therefore, our main aims are:
- To ascertain whether sarcopenia is present in GDM and, in that case, its prevalence;
- To identify risk factors for sarcopenia;
- To determine sarcopenia impact on pregnancy outcomes, and cognitive function.
During pregnancy, all women will undergo oral glucose tolerance test (OGTT) for assessment of the glucometabolic condition. Several clinical variables of interest in sarcopenia will also be recorded. As regards the OGTT data, special focus will be on the assessment of insulin resistance, both at fasting and during the dynamic conditions determined by the OGTT. Notably, the special interest for insulin resistance is due to the reason that this type of metabolic alteration is known to be a risk factor for sarcopenia. In fact, all women will then undergo testing for diagnosis of sarcopenia (or presarcopenia), and all data and parameters will be analyzed to identify relationships between sarcopenia-related variables and GDM-related ones. It is worth noting that in consideration of the exacerbated insulin resistance condition often observed in GDM, the investigators expect indeed a not negligible prevalence of sarcopenia (or at least presarcopenia) in GDM women, despite the young (non-elderly) age. In addition, since insulin resistance is often present in pregnancy even in the absence of dysglycemia, the investigators do not exclude to identify some cases of sarcopenia/presarcopenia even in pregnant non-GDM women. This study will be the basis for future studies (also of interventional type), especially in women with GDM for prevention of sarcopenia and related possible pregnancy complication and adverse pregnancy outcomes, as well as for possibly contributing to mitigation of risk for T2D development in later life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes (GDM) women | – | Diagnostic Test: Sarcopenia tests (for muscle mass, muscle function, physical performance), Diagnostic Test: Oral Glucose Tolerance Test, Other: Montreal Cognitive Assessment |
| Pregnant women without gestational diabetes (non-GDM) | – | Diagnostic Test: Sarcopenia tests (for muscle mass, muscle function, physical performance), Diagnostic Test: Oral Glucose Tolerance Test, Other: Montreal Cognitive Assessment |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women, based on the inclusion and exclusion criteria as outlined above.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarcopenia tests (for muscle mass, muscle function, physical performance)We are not aware of any other study performing sarcopenia tests in GDM (or in pregnancy in general), with the aim of assessing sarcopenia prevalence in GDM/pregnancy, and related possible adverse pregnancy outcomes. | Diagnostic test | Gestational diabetes (GDM) women, Pregnant women without gestational diabetes (non-GDM) |
| Oral Glucose Tolerance TestThe OGTT, in combination with the sarcopenia tests, will allow to explore the relationships between the glucometabolic condition and the muscle quality in the pregnant women, either with GDM or with normal glucose tolerance. | Diagnostic test | Gestational diabetes (GDM) women, Pregnant women without gestational diabetes (non-GDM) |
| Montreal Cognitive AssessmentThe MoCA questionnaire, in combination with the sarcopenia tests, will allow to explore the relationships between the cognitive function the presence of the sarcopenia syndrome in the pregnant women, either with GDM or with normal glucose tolerance. | Other | Gestational diabetes (GDM) women, Pregnant women without gestational diabetes (non-GDM) |
Primary outcome
Prevalence of sarcopenia/presarcopenia in pregnant women with and without gestational diabetes
Time frame: Between week 28 and week 32 of pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 41771588Dardano A, Daniele G, Gobl CS, Tura A. Protocol for a prospective cohort study for the assessment of sarcopenia in gestational diabetes: the SiGnal-D study. BMJ Open. 2026 Mar 2;16(3):e106837. doi: 10.1136/bmjopen-2025-106837.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Gestational Diabetes Mellitus (GDM), run by Istituto di Neuroscienze Consiglio Nazionale delle Ricerche at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Tura (+390498295786, andrea.tura@cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sarcopenia/presarcopenia in pregnant women with and without gestational diabetes (time frame: Between week 28 and week 32 of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06876090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.