Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Role of Hormonal and Metabolic Disorders in the Debelopment of Gestational Diabetes Mellitus (GDM)

11. juni 2026 opdateret af: Demidova Tatiana Yulievna, Pirogov Russian National Research Medical University

The work was carried out at the V. P. Demikhov City Clinical Hospital, a clinical base of the Department, and consisted of two consecutive stages, during which clinical material was collected between 2019 and 2021≥5.1mmol/L, but < 7.0 mmol/L, or when performing OGTT with 75 g of glucose during pregnancy at 24-28 weeks (after 1 hour ≥10.0 mmol/l and/or after 2 hours ≥8.5, but < 11.1 mmol/l). Individual outpatient records, data from instrumental and laboratory studies, and birth histories of pregnant women withThe 1st group consisted of 359 pregnant women who were diagnosed with GSD as part of the 1st stage of the disease screening (gestational age less than 24 weeks). The 2nd group included 151 pregnant women who were diagnosed with GSD as part of the 2nd stage of the disease screening (24 weeks of gestation or moreTo assess the dynamics of anthropometric indicators, the following were studied: body weight, height, BMI at the time of registration at the women's consultation, and gestational weight gain over the entire period of pregnancy. To assess the characteristics of the glycemic profile and calculate the parameters of glycemic variability, pregnant women underwent glycemic monitoring using the FreeStyle Libre Flash system (Abbott Diabetes Care, Witney,United Kingdom)current pregnancy Diagnosis of GDM (O24.4) was carried out in accordance with the criteria regulated by domestic clinical guidelines [21]. The diagnostic threshold for GDM was an increase in fasting blood glucose levels ≥5.1mmol/L, but < 7.0 mmol/L, or when performing OGTT with 75 g of glucose during pregnancy at 24-28 weeks (after 1 hour ≥10.0 mmol/l and/or after 2 hours ≥8.5, but < 11.1 mmol/l). Individual outpatient records, data from instrumental and laboratory studies, and birth histories of pregnant women with GDM, as well as the development history of newborns born to mothers with GDM. The main risk factors for the development of GDM (age, parity of childbirth, heredity, GDM and its indirect signs in the medical history, obesity, gestational weight gain (GWG); 40 gestational age and venous plasma glucose level at the time of diagnosis GDM; methods of GDM treatment (diet therapy/insulin therapy); complications of the current pregnancy (fetoplacental insufficiency (FPI), preeclampsia, eclampsia, threat of pregnancy termination, threat of premature birth, polyhydramnios, oligohydramnios). 213 women with GDM from the total analyzed group were delivered at the maternity hospital No. 8 in 2019-2020. Based on the birth histories and development histories of newborns from this group, the main outcomes of pregnancy, the frequency of complications during childbirth on the part of the mother and the fetus (macrosomia, birth trauma, fetal respiratory distress syndrome, weakness of labor activity, premature birth, premature rupture of membranes (PROM), congenital malformations, etc.), were evaluated. The postpartum glycemic levels of women with GDM and newborns were assessed.

The clinical and anamnestic features and risk factors for the development of adverse outcomes in GDM were established. To assess the risk factors for the development of perinatal complications in GDM, as well as the impact of its course and treatment on the development of perinatal pathology, all pregnant women were divided into two groups based on the gestational age at which GDM was detected.

The 1st group consisted of 359 pregnant women who were diagnosed with GDM as part of the 1st stage of the disease screening (gestational age less than 24 weeks). The 2nd group included 151 pregnant women who were diagnosed with GDM as part of the 2nd stage of the disease screening (24 weeks of gestation or more).

At the 2nd stage of the study, a prospective non-interventional observational study was conducted to identify the etiopathogenetic mechanisms of the development of GDM and to determine the clinical and laboratory markers of the formation of adverse perinatal outcomes. For this purpose, a new study group was formed using a random sample method, which included 91 pregnant women with a confirmed diagnosis of GSD at different stages of gestation, and they were monitored dynamically.

Inclusion criteria:

  • Pregnant women aged 18-45 years
  • Established diagnosis of gestational diabetes mellitus in accordance with current clinical guidelines
  • Single-pregnancy
  • Signed informed consent form

Exclusion criteria:

41

  • Diabetes mellitus diagnosed before pregnancy
  • Manifest diabetes mellitus detected during the current pregnancy
  • Multiple pregnancies
  • Severe concomitant pathology

Exclusion criteria:

• Refusal to participate in the study A set of research interventions was carried out in this group of subjects. To assess the clinical, anamnestic, metabolic, and hormonal profile, the primary medical documentation of pregnant women was analyzed (outpatient card of a pregnant woman, history of childbirth, and history of newborn development). To assess the dynamics of anthropometric indicat

Studieoversigt

Status

Afsluttet

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

601

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Moscow, Rusland
        • State clinical hospital named after V.P. Demikhov

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Pregnant women with GDM

Beskrivelse

Inclusion Criteria:

Established diagnosis of gestational diabetes mellitus in accordance with current clinical guidelines

Exclusion Criteria:

Diabetes mellitus diagnosed before pregnancy Manifest diabetes mellitus detected during the current pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Group 1
GDM diagnosed at 1st screening
Group 2
GDM diagnosed at 2nd screening

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in basal and stimulated insulin secretion
Tidsramme: 3 months postpartum
3 months postpartum

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. januar 2021

Primær færdiggørelse (Faktiske)

20. august 2021

Studieafslutning (Faktiske)

20. december 2022

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Svangerskabsdiabetes mellitus (GDM)

Abonner