Clinical trial NCT06876090: Sarcopenia in Gestational Diabetes
Official title: Sarcopenia in Gestational Diabetes: The SiGnal-D Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sarcopenia
Gestational Diabetes Mellitus (GDM)
Pregnancy Complications
Adverse Maternal and Neonatal Outcomes
Cognitive Function
Lead sponsor: Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Sponsor class: NETWORK
Collaborators: name: University of Pisa
name: Medical University of Vienna
First posted: 2025-03-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women, based on the inclusion and exclusion criteria as outlined above.

Brief 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. 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:

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.


Eligibility criteria: Inclusion Criteria:

At least one among the following conditions:

* Age equal or higher than 35 years;
* Body mass index (BMI) equal 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).

Primary outcomes:
measure: Prevalence of sarcopenia/presarcopenia in pregnant women with and without gestational diabetes
timeFrame: Between week 28 and week 32 of pregnancy
Secondary outcomes:
Other outcomes:
measure: Identification of pre-gestational factors (obstetric history, pre-pregnancy body weight, dietary and physical activity habits) and gestational factors (body mass index, blood pressure, OGTT values) with risk of sarcopenia
timeFrame: Between week 16 and week 32 of pregnancy
measure: Assessment of the potential impact of sarcopenia/presarcopenia on pregnancy outcomes (large or small for gestational age, LGA or SGA)
timeFrame: Between week 28 and week 32 of pregnancy
measure: Exploration of the potential relationship between sarcopenia (presence or no presence of sarcopenia) and cognitive function in pregnancy (MoCA questionnaire score)
timeFrame: Between week 28 and week 32 of pregnancy
measure: Assessment of the potential impact of sarcopenia/presarcopenia on pregnancy outcomes (type of delivery)
timeFrame: At the time of delivery
Locations:
city: Vienna
country: Austria
facility: Department of Obstetrics and Gynaecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Vienna
city: Padova
country: Italy
facility: Institute of Neuroscience, National Research Council
state: PD
city: Pisa
country: Italy
facility: Department of Clinical and Experimental Medicine, University of Pisa
state: PI
Study officials:
References: