Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-05-28
2026-04-30
Brief Summary
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1. To ascertain whether sarcopenia is present in GDM and, in that case, its prevalence;
2. To identify risk factors for sarcopenia;
3. 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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Gestational diabetes (GDM) women
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.
Oral Glucose Tolerance 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 Assessment
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.
Pregnant women without gestational diabetes (non-GDM)
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.
Oral Glucose Tolerance 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 Assessment
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.
Interventions
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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.
Oral Glucose Tolerance 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 Assessment
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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).
35 Years
FEMALE
No
Sponsors
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University of Pisa
OTHER
Medical University of Vienna
OTHER
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
NETWORK
Responsible Party
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Andrea Tura
Principal Investigator
Locations
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Department of Obstetrics and Gynaecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Vienna
Vienna, , Austria
Institute of Neuroscience, National Research Council
Padua, PD, Italy
Department of Clinical and Experimental Medicine, University of Pisa
Pisa, PI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B53D23022000006
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022XYXRJN_LS4_PRIN2022
Identifier Type: -
Identifier Source: org_study_id
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