Gestational DiabetesNCT04937348
Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
An observational study of Gestational Diabetes and Diabetes Mellitus, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Diabetes mellitus is one of the most common metabolic disorders complicating the course of pregnancy, which concerns pre-pregnancy diabetes (PGDM) - most often type 1 or type 2; and gestational diabetes (GDM) - treated with diet (G1) or insulin (G2). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Diabetes Mellitus, Neonate
- What is being tested?
- Acquisition and analysis of milk samples, Collection, preparation and analysis of mother's blood samples. and Body composition assessment
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 13 Dec 2019to 17 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study group included mothers with diagnosed diabetes and their newborns. Women with gestational diabetes, both treated with diet and treated with insulin - each group was supposed to include at least 20 patients. Additionally, if possible, women diagnosed with type 1 and type 2 pre-pregnancy diabetes or insulin resistance might have been included in the study. The control group consisted of 20 healthy women and their newborns.
Who may be able to join
- mother's age 18 - 45 years;
- delivery at term (≥ 37 + 0/7 weeks of pregnancy) or close to the delivery date (from 35 + 0/7 to 36 + 6/7 weeks of pregnancy), both by vaginal delivery and by caesarean section;
- single pregnancy;
- good condition of the child after birth, rated > 7 points on the Apgar score after the 1 st minute of life;
- feeding the baby only naturally (with breast or expressed breast milk) or mainly naturally;
- mother's informed and voluntary consent to participate in the study;
- mother's informed and voluntary consent to the participation of her child in the study.
Who cannot join
- mother's lack of consent to participate in the study;
- mother's lack of consent to the participation of her child in the study;
- mother's age <18 years and > 45 years;
- preterm labor <35 + 0/7 weeks of pregnancy;
- multiple pregnancy;
- the child's condition at birth is moderate or severe, rated at ≤ 7 points on the Apgar score after the 1st minute of life;
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- feeding a child exclusively or mainly with an infant formula;
- severe birth defects of a newborn,
- any clinical condition of the mother and / or the newborn that may affect the nutritional status of the newborn (IUGR, lack of medical care during pregnancy, addiction of the mother to alcohol or other psychoactive substances, nicotinism in pregnancy, uncontrolled asthma in the mother, metabolic diseases in the mother or newborn).
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department and Clinic of Neonatology, Jan Mikulicz-Radecki University Teaching Hospital, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
Diabetes mellitus is one of the most common metabolic disorders complicating the course of pregnancy, which concerns pre-pregnancy diabetes (PGDM) - most often type 1 or type 2; and gestational diabetes (GDM) - treated with diet (G1) or insulin (G2). Currently, in the pathogenesis of diabetes and the regulation of glucose metabolism, the role of tissue hormones, including adipokines, e.g., omentin-1, visfatin, have been considered. Adipokines might also affect the development of the fetus - mainly fetal adipose tissue gain. Their concentrations and activity depend on the maternal visceral fat content and concomitant metabolic disorders. It is known that adipokines are excreted in human milk during the lactation period.
The aim of the study was to assess the impact of diabetes during pregnancy, requiring treatment with diet or insulin, on the nutritional status of the newborn.
Read the detailed description
The detailed aim of the study was to analyze the relationship between the concentration of selected adipokines, visfatin and omentin-1 in the mother, and the nutritional status of the newborn (expressed as body composition and anthropometric measurements), as well as the composition of breast milk, and clinical data on the course of pregnancy, childbirth, puerperium (interview from mother) and the postnatal stay of the child in the hospital.
Primary protocol:
The research was going to be conducted twice, that is:
- in the period of postnatal hospitalization of the newborn, before discharge from the hospital (up to 7 days of age) in the Neonatology Clinic,
- in the 4th - 6th week of the child's life, after visiting the Neonatology Outpatient Clinic.
Apart from the clinical examination, anthropometric measurements and body composition measurements, the results of laboratory tests performed on a child during hospitalization up to the 7th day of life and at the 4-6 week of life were collected. The interview questionnaire was carried out twice with the child's mother. From the mother, at the same time, milk (colostrum and mature) and blood was collected for laboratory tests.
Further changes in the protocol (accepted by Bioethical Comitte):
- Extending the project with further study visits, i.e. 6-12 weeks and if the mother wishes to continue participation, 13 weeks - 6 months after delivery, in the case of sustained lactation and further breastfeeding, before introducing solid food into the child's diet. Substantiation: Due to the COVID-19 pandemic, the second project visit was abandoned. Based on telephone calls, the patients were still interested in participating, the more so as they had not completed the prescribed postpartum check-ups, their scheduled visits to specialists were canceled, and the infant vaccinations had been postponed. Patients also reported the need for lactation advice. Additional dates (6-12 weeks after childbirth and 13 weeks to 6 months after childbirth) would enable inviting mothers and their babies, providing medical or lactation advice according to their needs, as well as continuing the project among patients and their children who had been included in the study so far.
- Cooperation with Biobank of Wrocław Medical University was established.
Substantiation: Possibility of collecting and storing biological material for further research in safe and controlled conditions.
- Conditions
- Gestational Diabetes, Diabetes Mellitus, Neonate, Nutritional Status
- Being tested
- Acquisition and analysis of milk samples, Collection, preparation and analysis of mother's blood samples., Body composition assessment, Anthropometric measurements
- Keywords
- gestational diabetes, adipokines, visfatin, omentin, nutritional status, neonate, breast milk
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquisition and analysis of milk samplesDiagnostic test
In order to ensure reproducible results, breast milk samples were collected using a breast pump. Samples were taken in the morning, after the newborn was breastfed. The entire breast was emptied. In order to ensure the stability of the microbiological and nutritional composition, the milk samples were cooled immediately after collection, and then divided into test tubes and frozen (-80 C) until the laboratory tests were made.
The concentrations of macronutrients (protein, fat, carbohydrate) in breast milk were determined using a Human Milk Analyzer (HMA; Miris, Uppsala). Tissue hormones, e.g. adipokines: visfatin, omentin-1 were determined by ELISA method using commercial reagent kits.
Collection, preparation and analysis of mother's blood samples.Diagnostic test
Blood samples were collected from the mothers (fasting if possible) on the day the milk samples were taken. After collection, fasting glucose and insulin, as well as glycated hemoglobin were marked, and the other samples were centrifuged and frozen until analyzed (-80 C). Determination of adipokines was performed by ELISA method, using commercial reagent kits.
Body composition assessmentDiagnostic test
The body composition of newborns was determined by a non-invasive electrical bioimpedance method using the body composition analyzer.
Anthropometric measurementsOther
Based on the mother's medical records, maternal height and pregnancy weight changes were recorded. On the day the biological material is collected, the mother was weighed.
From the baby's documentation, measurements of the length, head circumference and body weight taken after delivery and during the hospitalization were recorded. These measurements were repeated on the days of the body composition analysis.
| Study group | Role | What they receive |
|---|---|---|
| GDM G1 | Mothers diagnosed with gestational diabetes mellitus, treated with diet; and their newborns Receives: Diagnostic Test: Acquisition and analysis of milk samples; Diagnostic Test: Collection, preparation and analysis of mother's blood samples.; Diagnostic Test: Body composition assessment; Other: Anthropometric measurements | |
| GDM G2 | Mothers diagnosed with gestational diabetes mellitus, treated with insulin; and their newborns Receives: Diagnostic Test: Acquisition and analysis of milk samples; Diagnostic Test: Collection, preparation and analysis of mother's blood samples.; Diagnostic Test: Body composition assessment; Other: Anthropometric measurements | |
| non-GDM / control group | Healthy, non-diabetic mothers, without disturbances in glucose metabolism; and their newborns.
Control group. Receives: Diagnostic Test: Acquisition and analysis of milk samples; Diagnostic Test: Collection, preparation and analysis of mother's blood samples.; Diagnostic Test: Body composition assessment; Other: Anthropometric measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat body mass [kg]
Changes in infantile fat body mass between 2 timepoints (the first week of life and the 2nd visit).
Measured: up to 6 months
Total body water [l]
Changes in infantile total body water between 2 timepoints (the first week of life and the 2nd visit).
Measured: up to 6 months
Anthropometrics: body weight [kg], length [cm], head circumference [cm].
Changes in infantile anthropometrics between 2 timepoints (the first week of life and the 2nd visit). On the basis of weight and length, BMI (kg/m2) and Ponderal Index will be calculated (kg/m3).
Measured: up to 6 months
Secondary outcomes (4)
Breast milk composition
Influence of diabetes mellitus in the course of pregnancy on the breast milk content of: protein [g/dl], carbohydrates [g/dl], fat [g/dl], energy [kcal/dl].
Measured: up to 6 months
Adipokines
Differences in omentin-1 and visfatin concentrations in serum and breastmilk samples between the study groups.
Measured: up to 6 months
Impact of maternal adipokines on infantile body fat mass.
Correlation of adipokines' concentrations with infantile fat mass will be analysed.
Measured: up to 6 months
Impact of maternal adipokines on breast milk composition.
Correlation of adipokines' concentrations with breast milk content of: protein [g/dl], carbohydrates [g/dl], fat [g/dl], energy [kcal/dl] will be analysed.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start13 Dec 2019
- Primary completion5 Feb 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937348
- Sponsor's protocol ID
- 773/2019
- Other IDs
- STM.A300.20.143
- Status last verified
- May 2021
- First submitted
- 11 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
- ClinicalTrials.gov ID
- NCT04937348
- Acronym / sponsor ID
- 773/2019
- Conditions
- Gestational Diabetes, Diabetes Mellitus, Neonate, Nutritional Status
- Keywords
- gestational diabetes, adipokines, visfatin, omentin, nutritional status, neonate, breast milk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes mellitus is one of the most common metabolic disorders complicating the course of pregnancy, which concerns pre-pregnancy diabetes (PGDM) - most often type 1 or type 2; and gestational diabetes (GDM) - treated with diet (G1) or insulin (G2). Currently, in the pathogenesis of diabetes and the regulation of glucose metabolism, the role of tissue hormones, including adipokines, e.g., omentin-1, visfatin, have been considered. Adipokines might also affect the development of the fetus - mainly fetal adipose tissue gain. Their concentrations and activity depend on the maternal visceral fat content and concomitant metabolic disorders. It is known that adipokines are excreted in human milk during the lactation period.
The aim of the study was to assess the impact of diabetes during pregnancy, requiring treatment with diet or insulin, on the nutritional status of the newborn.
Detailed description
The detailed aim of the study was to analyze the relationship between the concentration of selected adipokines, visfatin and omentin-1 in the mother, and the nutritional status of the newborn (expressed as body composition and anthropometric measurements), as well as the composition of breast milk, and clinical data on the course of pregnancy, childbirth, puerperium (interview from mother) and the postnatal stay of the child in the hospital.
Primary protocol:
The research was going to be conducted twice, that is:
- in the period of postnatal hospitalization of the newborn, before discharge from the hospital (up to 7 days of age) in the Neonatology Clinic,
- in the 4th - 6th week of the child's life, after visiting the Neonatology Outpatient Clinic.
Apart from the clinical examination, anthropometric measurements and body composition measurements, the results of laboratory tests performed on a child during hospitalization up to the 7th day of life and at the 4-6 week of life were collected. The interview questionnaire was carried out twice with the child's mother. From the mother, at the same time, milk (colostrum and mature) and blood was collected for laboratory tests.
Further changes in the protocol (accepted by Bioethical Comitte):
- Extending the project with further study visits, i.e. 6-12 weeks and if the mother wishes to continue participation, 13 weeks - 6 months after delivery, in the case of sustained lactation and further breastfeeding, before introducing solid food into the child's diet. Substantiation: Due to the COVID-19 pandemic, the second project visit was abandoned. Based on telephone calls, the patients were still interested in participating, the more so as they had not completed the prescribed postpartum check-ups, their scheduled visits to specialists were canceled, and the infant vaccinations had been postponed. Patients also reported the need for lactation advice. Additional dates (6-12 weeks after childbirth and 13 weeks to 6 months after childbirth) would enable inviting mothers and their babies, providing medical or lactation advice according to their needs, as well as continuing the project among patients and their children who had been included in the study so far.
- Cooperation with Biobank of Wrocław Medical University was established.
Substantiation: Possibility of collecting and storing biological material for further research in safe and controlled conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GDM G1 | – | Diagnostic Test: Acquisition and analysis of milk samples, Diagnostic Test: Collection, preparation and analysis of mother's blood samples., Diagnostic Test: Body composition assessment, Other: Anthropometric measurementsMothers diagnosed with gestational diabetes mellitus, treated with diet; and their newborns |
| GDM G2 | – | Diagnostic Test: Acquisition and analysis of milk samples, Diagnostic Test: Collection, preparation and analysis of mother's blood samples., Diagnostic Test: Body composition assessment, Other: Anthropometric measurementsMothers diagnosed with gestational diabetes mellitus, treated with insulin; and their newborns |
| non-GDM / control group | – | Diagnostic Test: Acquisition and analysis of milk samples, Diagnostic Test: Collection, preparation and analysis of mother's blood samples., Diagnostic Test: Body composition assessment, Other: Anthropometric measurementsHealthy, non-diabetic mothers, without disturbances in glucose metabolism; and their newborns. Control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study group included mothers with diagnosed diabetes and their newborns. Women with gestational diabetes, both treated with diet and treated with insulin - each group was supposed to include at least 20 patients. Additionally, if possible, women diagnosed with type 1 and type 2 pre-pregnancy diabetes or insulin resistance might have been included in the study. The control group consisted of 20 healthy women and their newborns.
Key inclusion criteria (7 listed)
- mother's age 18 - 45 years;
- delivery at term (≥ 37 + 0/7 weeks of pregnancy) or close to the delivery date (from 35 + 0/7 to 36 + 6/7 weeks of pregnancy), both by vaginal delivery and by caesarean section;
- single pregnancy;
- good condition of the child after birth, rated > 7 points on the Apgar score after the 1 st minute of life;
- feeding the baby only naturally (with breast or expressed breast milk) or mainly naturally;
Key exclusion criteria (9 listed)
- mother's lack of consent to participate in the study;
- mother's lack of consent to the participation of her child in the study;
- mother's age <18 years and > 45 years;
- preterm labor <35 + 0/7 weeks of pregnancy;
- multiple pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acquisition and analysis of milk samplesIn order to ensure reproducible results, breast milk samples were collected using a breast pump. Samples were taken in the morning, after the newborn was breastfed. The entire breast was emptied. In order to ensure the stability of the microbiological and nutritional composition, the milk samples were cooled immediately after collection, and then divided into test tubes and frozen (-80 C) until the laboratory tests were made. The concentrations of macronutrients (protein, fat, carbohydrate) in breast milk were determined using a Human Milk Analyzer (HMA; Miris, Uppsala). Tissue hormones, e.g. adipokines: visfatin, omentin-1 were determined by ELISA method using commercial reagent kits. | Diagnostic test | GDM G1, GDM G2, non-GDM / control group |
| Collection, preparation and analysis of mother's blood samples.Blood samples were collected from the mothers (fasting if possible) on the day the milk samples were taken. After collection, fasting glucose and insulin, as well as glycated hemoglobin were marked, and the other samples were centrifuged and frozen until analyzed (-80 C). Determination of adipokines was performed by ELISA method, using commercial reagent kits. | Diagnostic test | GDM G1, GDM G2, non-GDM / control group |
| Body composition assessmentThe body composition of newborns was determined by a non-invasive electrical bioimpedance method using the body composition analyzer. | Diagnostic test | GDM G1, GDM G2, non-GDM / control group |
| Anthropometric measurementsBased on the mother's medical records, maternal height and pregnancy weight changes were recorded. On the day the biological material is collected, the mother was weighed. From the baby's documentation, measurements of the length, head circumference and body weight taken after delivery and during the hospitalization were recorded. These measurements were repeated on the days of the body composition analysis. | Other | GDM G1, GDM G2, non-GDM / control group |
Primary outcome
Fat body mass [kg]
Time frame: up to 6 months
Changes in infantile fat body mass between 2 timepoints (the first week of life and the 2nd visit).
Total body water [l]
Time frame: up to 6 months
Changes in infantile total body water between 2 timepoints (the first week of life and the 2nd visit).
Anthropometrics: body weight [kg], length [cm], head circumference [cm].
Time frame: up to 6 months
Changes in infantile anthropometrics between 2 timepoints (the first week of life and the 2nd visit). On the basis of weight and length, BMI (kg/m2) and Ponderal Index will be calculated (kg/m3).
4 secondary outcomes
Breast milk composition
Time frame: up to 6 months
Adipokines
Time frame: up to 6 months
Impact of maternal adipokines on infantile body fat mass.
Time frame: up to 6 months
Impact of maternal adipokines on breast milk composition.
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Diabetes Mellitus, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat body mass [kg] (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.