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

NCT07652554 | Completed

• 1 other identifier: GDM10191315
• Study Type: observational
• Target: 601
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (1)

• Change in basal and stimulated insulin secretion

  3 months postpartum

Study Arms (2)

Group 1

GDM diagnosed at 1st screening

Group 2

GDM diagnosed at 2nd screening

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women with GDM

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

State clinical hospital named after V.P. Demikhov

Moscow, Russia

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 17, 2026
• Study Start: January 10, 2021
• Primary Completion: August 20, 2021
• Study Completion: December 20, 2022
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

RU (1)