Sarcopenia in Gestational Diabetes

NCT06876090 | Recruiting

• 2 other identifiers: 2022XYXRJN_LS4_PRIN2022B53D23022000006
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 3

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. 1.To ascertain whether sarcopenia is present in GDM and, in that case, its prevalence;
2. 2.To identify risk factors for sarcopenia;
3. 3.To determine sarcopenia impact on pregnancy outcomes, and cognitive function.

Conditions

Sarcopenia; Gestational Diabetes Mellitus (GDM); Pregnancy Complications; Adverse Maternal and Neonatal Outcomes; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Prevalence of sarcopenia/presarcopenia in pregnant women with and without gestational diabetes

  Between week 28 and week 32 of pregnancy

Other Outcomes (4)

• 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

  Between week 16 and week 32 of pregnancy

• Assessment of the potential impact of sarcopenia/presarcopenia on pregnancy outcomes (large or small for gestational age, LGA or SGA)

  Between week 28 and week 32 of pregnancy

• Exploration of the potential relationship between sarcopenia (presence or no presence of sarcopenia) and cognitive function in pregnancy (MoCA questionnaire score)

  Between week 28 and week 32 of pregnancy

Study Arms (2)

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

Interventions

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.

Gestational diabetes (GDM) women; Pregnant women without gestational diabetes (non-GDM)

Oral Glucose Tolerance Test DIAGNOSTIC_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.

Gestational diabetes (GDM) women; Pregnant women without gestational diabetes (non-GDM)

Montreal Cognitive Assessment OTHER

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.

Gestational diabetes (GDM) women; Pregnant women without gestational diabetes (non-GDM)

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women, based on the inclusion and exclusion criteria as outlined above.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituto di Neuroscienze Consiglio Nazionale delle Ricerche: lead
• University of Pisa: collaborator
• Medical University of Vienna: collaborator

Study Sites (3)

Department of Obstetrics and Gynaecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Vienna

Vienna, 1090, Austria

RECRUITING

Institute of Neuroscience, National Research Council

Padua, PD, 35127, Italy

ACTIVE NOT RECRUITING

Department of Clinical and Experimental Medicine, University of Pisa

Pisa, PI, 56124, Italy

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Diabetes, Gestational; Pregnancy Complications

Interventions

Glucose Tolerance Test; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Andrea Tura

CONTACT

+390498295786; andrea.tura@cnr.it

Angela Dardano

CONTACT

+39050995146; angela.dardano@unipi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 14, 2025
• Study Start: May 28, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

IT (2); AU (1)