Abstract

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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06876090

Funding Statement

The study was funded by the Ministry of University and Research, Rome, Italy, in the context of funding from European Union, Next Generation EU, Mission 4, Component 2 (project identifiers: CUP B53D23022000006; 2022XYXRJN_LS4_PRIN2022; project title: Sarcopenia in Gestational Diabetes: The SiGnal-D Study).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The protocol has been approved by the Comitato Etico Regione Toscana - Area Vasta Nord Ovest (CEAVNO), Pisa, Italy, on the 25/07/2024, ID 25652, and by the Local Ethics Committee of the Medical University of Vienna, Vienna, Austria, on the 17/06/2024, n. 1458/2024.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Not applicable (study protocol)

List of abbreviationsT2Dtype 2 diabetesGDMgestational diabetes mellitusBMIbody mass indexOGTToral glucose tolerance testEWGSOPEuropean Working Group on Sarcopenia in Older PeopleBIAbioelectrical impedance analysisSMskeletal muscle massSMIskeletal muscle mass indexMoCAMontreal Cognitive AssessmentTMTTrail Making TestfNIRSfunctional near-infrared spectroscopyEEGelectroencephalographyAPGARappearance, pulse, grimace, activity, respirationSARCOsarcopenianonSARCOno sarcopenianonGDMno GDMROCreceiver operating characteristic