Protocol for a prospective cohort study for the assessment of sarcopenia in gestational diabetes: The SiGnal-D study
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Background
Sarcopenia is characterized by loss of muscle mass and strength. Although aging is the most likely sarcopenia risk factor, sarcopenia is frequent even in non-elderly people. Type 2 diabetes (T2D) is a risk factor for sarcopenia, as T2D shares with sarcopenia several etiological factors. On the other side, gestational diabetes mellitus (GDM) is characterized by metabolic alterations similar to those of T2D, although its distinctive trait is insulin resistance (present even in physiologic pregnancies). Hence, GDM presents two major risk factors for sarcopenia, i.e., dysglycemia and insulin resistance. Moreover, the number of pregnancies above 40 years is increasing, therefore in an age range where sarcopenia prevalence is already not negligible. However, there is lack of data about sarcopenia prevalence in GDM and about the impact on pregnancy outcomes. Thus, we plan evaluating sarcopenia prevalence in women with GDM (and in non-GDM pregnant women), identifying risk factors, and determining the impact on delivery as well as on maternal and fetal outcomes.
Methods
We will recruit 100 GDM and 100 non-GDM women. All women will undergo oral glucose tolerance test within week 24-28 for possible GDM diagnosis. Muscle/physical performance tests will be performed at week 28-32 for possible diagnosis of sarcopenia/presarcopenia. Cognitive function will also be assessed. For all women we will collect information regarding pregnancy progression, along with any complication. Collected data will be analyzed according to the study main objectives: i) determining the prevalence of sarcopenia/presarcopenia in pregnancy with and without GDM, ii) identifying factors associated with sarcopenia risk, iii) determining the impact of sarcopenia/presarcopenia on pregnancy outcomes, iv) exploring the relationship between sarcopenia and cognitive function.
Discussion
The present study will provide information on sarcopenia/presarcopenia prevalence in GDM and, possibly, in pregnancy uncomplicated by dysglycemia. Furthermore, the study will provide knowledge on the main factors associated to sarcopenia/presarcopenia in GDM/pregnancy. The identification of such factors will be relevant for an initial guidance for treatments that may prevent sarcopenia in GDM/pregnant women. This will become of even greater interest if sarcopenia/presarcopenia shows an impact on pregnancy outcomes, especially in GDM women.
Trial registration
ClinicalTrials.gov Identifier: NCT06876090 ; Registration Date: 2025-03-14
