Level B· Emerging Clinical EvidenceClinical Trial

The possible role of visceral fat in early pregnancy as a predictor of gestational diabetes mellitus by regulating adipose-derived exosomes miRNA-148 family: protocol for a nested case-control study in a cohort study.

Zhang Z., Xu Q., Chen Y., Sui L., Jiang L., Shen Q.

Clinical Trial with a reported sample of 3000 on Type 2 Diabetes, published in BMC Pregnancy Childbirth (2021) — summary generated from the PubMed abstract.

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Study type
Clinical Trial
Journal
BMC Pregnancy Childbirth (2021)
Country
England
Reported sample size
3000
PMID
33784999
DOI
10.1186/s12884-021-03737-1

Abstract (original English)

Gestational diabetes mellitus (GDM) has become alarming public health concern. It is associated with adverse pregnancy outcomes and increased risk of postpartum type 2 diabetes. Pre-pregnant body mass index (BMI), waist circumference and other anthropometric parameters have been proposed to predict GDM. However, visceral fat thickness can better reflect the distribution of body fat, and may more accurately predict the risk of GDM. Visceral fat thickness may lead to insulin resistance by regulating the adipose-derived exosomes miRNA-148 family, which affect the development of GDM. Evidence from prospective cohort studies on visceral fat thickness as a predictor of GDM and the possible mechanisms is still insufficient. In this prospective cohort study, we will recruit 3000 women at first antenatal visit between 4 and 12 weeks of gestation. Baseline socio-demographic factors and visceral fat thickness will be assessed by questionnaire form and the ultrasonic measurement, respectively. At 20 weeks of gestation, 10 ml blood samples will be drawn and we will extract adipose-derived exosomes miRNA on the basis of nested case-control study. GDM will be screened at 24-28 weeks' gestation and the expression of miRNA-148 family between pregnant women with GDM and without GDM will be analyzed. Intermediary analysis will be used to investigate whether visceral fat thickness can predict GDM

What this study does not prove

  • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Several human studies exist, but sample sizes, methodology, or follow-up remain limited, so conclusions are not firm.

How we grade evidence
AdiposityAdultBlood GlucoseCase-Control StudiesDiabetes, GestationalExosomesFemaleGlucose Tolerance TestHumansIncidence

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