Gestational DiabetesNCT05463237
Comparison of Visceral Adipokines Visfatin, Vaspin and Omentin Levels in Gestational Diabetes Mellitus Pregnant Women
An observational study of Gestational Diabetes and Obesity, run by Siirt University at 1 site in Turkey (Türkiye).
Trial summary
The prevalence of maternal obesity is increasing rapidly worldwide and constitutes an important obstetric problem that increases mortality and morbidity in both mothers and infants. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Obesity, Visceral Obesity
- What is being tested?
- oral glucose tolerance test and Blood sample
- Type of treatment
- Pill or oral medicine
- How many people
- 174 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2022to 25 Aug 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women over the age of 18 who are in the first trimester of pregnancy and are not diagnosed with diabetes
Who may be able to join
- >18 years of age
- At the 2.st trimester of pregnancy
Who cannot join
- History of with diabetes mellitus
- Morbidly obese pregnants
- History of abdomen liposuction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relation Between Visceral Adipokines Gestational Diabetes Mellitus
The prevalence of maternal obesity is increasing rapidly worldwide and constitutes an important obstetric problem that increases mortality and morbidity in both mothers and infants. Obese women are prone to pregnancy complications such as gestational diabetes mellitus (GDM), and children of obese mothers are more likely to develop cardiovascular and metabolic disease later in life. The risk of developing GDM in obese pregnants is 1.3-3.8 times higher than in pregnant women with a normal body mass index, and approximately 70% of women with GDM remain at risk of developing type 2 diabetes until 28 years postpartum. Gestational diabetes mellitus (GDM) affects approximately 6% of pregnant women and its prevalence is increasing in parallel with the obesity epidemic. GDM is associated with an increased risk of adverse pregnancy outcomes, including macrosomia, preterm delivery, neonatal hypoglycemia, neonatal jaundice, and congenital anomalies. It is also associated with a higher incidence of type 2 diabetes mellitus after birth. It is known that visceral adipose tissue increases in obese women. It is thought that there is a relationship between visceral adipose tissue increase and diabetes. In this study, the levels of new adipocytokines such as Visfatin, Vaspin and Omentin secreted from visceral adipose tissue in patients diagnosed with GDM will be measured.
Read the detailed description
The investigators aim in this study the levels of Visfatin, Vaspin and Omentin secreted from this tissue in pregnant women diagnosed with GDM by oral glucose tolerance test (OGTT) between 24-28 weeks of gestation and to determine if there is a relationship between these parameters. For this purpose, , and 87 pregnant women with gestational diabetes diagnosed at 24-28 weeks from the same patient group will be included in the study. . The same number of non-GDM control group pregnant women will also be included in the study at 24-28 weeks. Age, gestational week, pregnancy history (gravida, parity, abortion, missed, ectopic), medical history, preconceptional BMI, current BMI, triglyceride, VLDL, HDL, LDL, cholesterol, HOMA-IR, C-peptide, insulin, Hba1c levels will be saved. In the 2nd trimester, between 24-26 weeks, OGTT will be performed on the patients and the results will be recorded. Visfatin, Vaspin and Omentin levels will be checked and recorded in patients diagnosed with GDM.
- Conditions
- Gestational Diabetes, Obesity, Visceral Obesity
- Being tested
- oral glucose tolerance test, Blood sample
- Medical subject headings
- Diabetes, Gestational, Obesity, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose tolerance testDiagnostic test
oral glucose tolerance test (OGTT) used for the diagnosis of gestational diabetes mellitus between 24-28 weeks of gestation
Blood sampleDiagnostic test
Measurement of blood Visfatin, Vaspin and Omentin levels in pregnant women with diabetes
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with gestational diabetes(n:87) | Visceral adipokine level will be examined in pregnant women with gestational diabetes. Receives: Diagnostic Test: oral glucose tolerance test; Diagnostic Test: Blood sample | |
| Control group pregnant (n:87) | Visceral adipokine level will be examined in pregnant women with normal pregnant . Receives: Diagnostic Test: oral glucose tolerance test; Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-28. Visceral Adipokine Levels in Pregnant Women with Gestational Diabetes Between Weeks
VASPIN, VISFATIN, OMENTIN levels will be measured in patients with gestational diabetic,
Measured: Between 24-28 weeks of pregnancy, (an average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start31 Oct 2022
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siirt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serif Aksin, Siirt University
- Investigators
- Şerif Aksin, Assoc.Prof, Study director, Siirt University Medical Faculty Obstetrics and Gynecology DepartmantŞerif Aksin, Study director, Siirt Üniversity Medical Faculty Obstetrics and Gynecology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463237
- Sponsor's protocol ID
- SiirtUNI
- Status last verified
- Aug 2023
- First submitted
- 30 Jun 2022
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Visceral Adipokines Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05463237
- Acronym / sponsor ID
- SiirtUNI
- Conditions
- Gestational Diabetes, Obesity, Visceral Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Siirt UniversityUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 18 Jul 2022 (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.
The prevalence of maternal obesity is increasing rapidly worldwide and constitutes an important obstetric problem that increases mortality and morbidity in both mothers and infants. Obese women are prone to pregnancy complications such as gestational diabetes mellitus (GDM), and children of obese mothers are more likely to develop cardiovascular and metabolic disease later in life. The risk of developing GDM in obese pregnants is 1.3-3.8 times higher than in pregnant women with a normal body mass index, and approximately 70% of women with GDM remain at risk of developing type 2 diabetes until 28 years postpartum. Gestational diabetes mellitus (GDM) affects approximately 6% of pregnant women and its prevalence is increasing in parallel with the obesity epidemic. GDM is associated with an increased risk of adverse pregnancy outcomes, including macrosomia, preterm delivery, neonatal hypoglycemia, neonatal jaundice, and congenital anomalies. It is also associated with a higher incidence of type 2 diabetes mellitus after birth. It is known that visceral adipose tissue increases in obese women. It is thought that there is a relationship between visceral adipose tissue increase and diabetes. In this study, the levels of new adipocytokines such as Visfatin, Vaspin and Omentin secreted from visceral adipose tissue in patients diagnosed with GDM will be measured.
Detailed description
The investigators aim in this study the levels of Visfatin, Vaspin and Omentin secreted from this tissue in pregnant women diagnosed with GDM by oral glucose tolerance test (OGTT) between 24-28 weeks of gestation and to determine if there is a relationship between these parameters. For this purpose, , and 87 pregnant women with gestational diabetes diagnosed at 24-28 weeks from the same patient group will be included in the study. . The same number of non-GDM control group pregnant women will also be included in the study at 24-28 weeks. Age, gestational week, pregnancy history (gravida, parity, abortion, missed, ectopic), medical history, preconceptional BMI, current BMI, triglyceride, VLDL, HDL, LDL, cholesterol, HOMA-IR, C-peptide, insulin, Hba1c levels will be saved. In the 2nd trimester, between 24-26 weeks, OGTT will be performed on the patients and the results will be recorded. Visfatin, Vaspin and Omentin levels will be checked and recorded in patients diagnosed with GDM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with gestational diabetes(n:87) | – | Diagnostic Test: oral glucose tolerance test, Diagnostic Test: Blood sampleVisceral adipokine level will be examined in pregnant women with gestational diabetes. |
| Control group pregnant (n:87) | – | Diagnostic Test: oral glucose tolerance test, Diagnostic Test: Blood sampleVisceral adipokine level will be examined in pregnant women with normal pregnant . |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women over the age of 18 who are in the first trimester of pregnancy and are not diagnosed with diabetes
Key inclusion criteria (2 listed)
- >18 years of age
- At the 2.st trimester of pregnancy
Key exclusion criteria (3 listed)
- History of with diabetes mellitus
- Morbidly obese pregnants
- History of abdomen liposuction
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 |
|---|---|---|
| oral glucose tolerance testoral glucose tolerance test (OGTT) used for the diagnosis of gestational diabetes mellitus between 24-28 weeks of gestation | Diagnostic test | Control group pregnant (n:87), Pregnant women with gestational diabetes(n:87) |
| Blood sampleMeasurement of blood Visfatin, Vaspin and Omentin levels in pregnant women with diabetes | Diagnostic test | Control group pregnant (n:87), Pregnant women with gestational diabetes(n:87) |
Primary outcome
24-28. Visceral Adipokine Levels in Pregnant Women with Gestational Diabetes Between Weeks
Time frame: Between 24-28 weeks of pregnancy, (an average of 6 months)
VASPIN, VISFATIN, OMENTIN levels will be measured in patients with gestational diabetic,
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 28 Aug 2023.
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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.
Şerif Aksin, Assoc.Prof study director
Siirt University Medical Faculty Obstetrics and Gynecology Departmant
Şerif Aksin study director
Siirt Üniversity Medical Faculty Obstetrics and Gynecology Department
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 Obesity, run by Siirt University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 28 Aug 2023. 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 Turkey (Türkiye). 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?
24-28. Visceral Adipokine Levels in Pregnant Women with Gestational Diabetes Between Weeks (time frame: Between 24-28 weeks of pregnancy, (an average of 6 months)). 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 28 Aug 2023.