Actively Recruiting

Age: 35Years +
FEMALE
NCT06876090

Sarcopenia in Gestational Diabetes

Led by Istituto di Neuroscienze Consiglio Nazionale delle Ricerche · Updated on 2025-11-21

200

Participants Needed

3

Research Sites

44 weeks

Total Duration

On this page

Sponsors

I

Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

Lead Sponsor

U

University of Pisa

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sarcopenia in Gestational Diabetes

Who Can Participate

Age: 35Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age equal to or higher than 35 years
  • Body mass index (BMI) equal to or higher than 25 kg/m^2
  • Blood sugar levels between 5.6 and 6.9 mmol/L before or at the beginning of pregnancy
  • History of fetal macrosomia in previous pregnancy
  • History of gestational diabetes mellitus (GDM) in previous pregnancy
  • First-degree family history of diabetes
Not Eligible

You will not qualify if you...

  • Does not meet at least one of the inclusion criteria
  • Twin pregnancy
  • Presence of any known disease or disorder that may affect muscle mass or function
  • Neurological or psychiatric diseases
  • Already diagnosed diabetes (such as type 1 or type 2 diabetes)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

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

Vienna, Austria, 1090

Actively Recruiting

2

Institute of Neuroscience, National Research Council

Padova, PD, Italy, 35127

Active, Not Recruiting

3

Department of Clinical and Experimental Medicine, University of Pisa

Pisa, PI, Italy, 56124

Actively Recruiting

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Research Team

A

Andrea Tura

CONTACT

A

Angela Dardano

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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