Birth WeightNCT06333548
Cord Blood Alarin Levels in Term Babies
An observational study of Birth Weight, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. Thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin. Read more about this study
- Who is it for?
- Ages 1 minute to 5 minutes
- Conditions the study is for
- Birth Weight
- What is being tested?
- Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2023to 15 Jan 2024
- 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 1 minute to 5 minutes
- All sexes
- No healthy volunteers
- Child
Study population: Babies born between the planned dates and whose families gave consent for the study were divided into four different groups according to their characteristics: 1. Babies with normal weight according to gestational age (AGA): 25 babies were included in the study. 2. Low weight babies for gestational age (SGA): 20 babies were included in the study. 3. Large-weight babies for gestational age (LGA): 22 babies were included in the study. 4. Babies whose mothers had gestational diabetes mellitus: 20 babies were included in the study.
Who may be able to join
- Babies given consent by their families
- Healthy babies
Who cannot join
- Babies with syndromic appearance or any accompanying disease
- Babies whose family does not give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cord Blood Alarin Levels in Term Babies According to Birth Weight
In this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. Thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin.
Read the detailed description
Studies have shown that the galanin neuropeptide family plays a role in regulating appetite, insulin resistance, obesity, hypertension and metabolism. Alarin is a peptide consisting of 25 amino acids. Current research shows that allerin plays an important role in the emergence and development of diabetes and obesity. There are studies that found that the serum alarin level increased significantly in patients with impaired glucose tolerance and type 2 diabetes mellitus. Additionally, studies have found that both non-obese and obese type 2 diabetes mellitus serum alarin levels increase.
Studies in the literature are related to adults, and there are no studies on alarin levels in newborn babies.
Based on the alarin studies available in the literature, the investigators determined whether there is a relationship between the alarin level and the baby's birth weight by comparing the alarin level in the cord blood of babies with a high birth weight according to their gestational age (both babies of diabetic mothers and babies of non-diabetic mothers) compared to babies whose birth weight is within the normal range. the investigators aimed to find it.
- Conditions
- Birth Weight
- Being tested
- Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM
- Keywords
- NEWBORN, ALARİN, UMBİLİCAL CORD BLOOD
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDMDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Appropriate for gestational age | Appropriate for gestational age Receives: Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM | |
| small for gestational age | small for gestational age Receives: Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM | |
| large for gestational age | large for gestational age Receives: Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM | |
| Baby of mother diagnosed with GDM | Baby of mother diagnosed with gestational diabetes mellitus Receives: Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of cord blood alarin levels of babies in different groups according to birth weight (low-appropriate-large) and babies of mothers diagnosed with gestational diabetes regardless of birth weight.
umbilical cord blood alarin levels
Measured: postnatal 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start18 Sep 2023
- Primary completion23 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Birth WeightStudies 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Buyukeren, Konya City Hospital
- Investigators
- MELEK BUYUKEREN, Study director, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333548
- Sponsor's protocol ID
- KSH_MB_2024_1
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan and Clinical Study Report
Publications
Zhou X, Luo M, Zhou S, Cheng Z, Chen Z, Yu X. Plasma Alarin Level and Its Influencing Factors in Obese Newly Diagnosed Type 2 Diabetes Patients. Diabetes Metab Syndr Obes. 2021 Jan 27;14:379-385. doi: 10.2147/DMSO.S290072. eCollection 2021.
PubMed 33536771Hu W, Fan X, Zhou B, Li L, Tian B, Fang X, Xu X, Liu H, Yang G, Liu Y. Circulating alarin concentrations are high in patients with type 2 diabetes and increased by glucagon-like peptide-1 receptor agonist treatment: An Consort-compliant study. Medicine (Baltimore). 2019 Jul;98(28):e16428. doi: 10.1097/MD.0000000000016428.
PubMed 31305464
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cord Blood Alarin Levels in Term Babies According to Birth Weight
- ClinicalTrials.gov ID
- NCT06333548
- Acronym / sponsor ID
- KSH_MB_2024_1
- Conditions
- Birth Weight
- Keywords
- NEWBORN, ALARİN, UMBİLİCAL CORD BLOOD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 27 Mar 2024 (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.
In this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. Thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin.
Detailed description
Studies have shown that the galanin neuropeptide family plays a role in regulating appetite, insulin resistance, obesity, hypertension and metabolism. Alarin is a peptide consisting of 25 amino acids. Current research shows that allerin plays an important role in the emergence and development of diabetes and obesity. There are studies that found that the serum alarin level increased significantly in patients with impaired glucose tolerance and type 2 diabetes mellitus. Additionally, studies have found that both non-obese and obese type 2 diabetes mellitus serum alarin levels increase.
Studies in the literature are related to adults, and there are no studies on alarin levels in newborn babies.
Based on the alarin studies available in the literature, the investigators determined whether there is a relationship between the alarin level and the baby's birth weight by comparing the alarin level in the cord blood of babies with a high birth weight according to their gestational age (both babies of diabetic mothers and babies of non-diabetic mothers) compared to babies whose birth weight is within the normal range. the investigators aimed to find it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Appropriate for gestational age | – | Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDMAppropriate for gestational age |
| small for gestational age | – | Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDMsmall for gestational age |
| large for gestational age | – | Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDMlarge for gestational age |
| Baby of mother diagnosed with GDM | – | Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDMBaby of mother diagnosed with gestational diabetes mellitus |
Who may qualify
- Ages
- 1 minute to 5 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies born between the planned dates and whose families gave consent for the study were divided into four different groups according to their characteristics: 1. Babies with normal weight according to gestational age (AGA): 25 babies were included in the study. 2. Low weight babies for gestational age (SGA): 20 babies were included in the study. 3. Large-weight babies for gestational age (LGA): 22 babies were included in the study. 4. Babies whose mothers had gestational diabetes mellitus: 20 babies were included in the study.
Key inclusion criteria (2 listed)
- Babies given consent by their families
- Healthy babies
Key exclusion criteria (2 listed)
- Babies with syndromic appearance or any accompanying disease
- Babies whose family does not give consent
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 |
|---|---|---|
| Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDMNo intervention | Diagnostic test | Appropriate for gestational age, Baby of mother diagnosed with GDM, large for gestational age, small for gestational age |
Primary outcome
Comparison of cord blood alarin levels of babies in different groups according to birth weight (low-appropriate-large) and babies of mothers diagnosed with gestational diabetes regardless of birth weight.
Time frame: postnatal 5 minutes
umbilical cord blood alarin levels
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 29 Mar 2024.
- Results publication: PubMed 33536771Zhou X, Luo M, Zhou S, Cheng Z, Chen Z, Yu X. Plasma Alarin Level and Its Influencing Factors in Obese Newly Diagnosed Type 2 Diabetes Patients. Diabetes Metab Syndr Obes. 2021 Jan 27;14:379-385. doi: 10.2147/DMSO.S290072. eCollection 2021.
- Results publication: PubMed 31305464Hu W, Fan X, Zhou B, Li L, Tian B, Fang X, Xu X, Liu H, Yang G, Liu Y. Circulating alarin concentrations are high in patients with type 2 diabetes and increased by glucagon-like peptide-1 receptor agonist treatment: An Consort-compliant study. Medicine (Baltimore). 2019 Jul;98(28):e16428. doi: 10.1097/MD.0000000000016428.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan and Clinical Study Report
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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.
MELEK BUYUKEREN study director
Konya City Hospital
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 Birth Weight, run by Konya City Hospital 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 2 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 29 Mar 2024. 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?
Comparison of cord blood alarin levels of babies in different groups according to birth weight (low-appropriate-large) and babies of mothers diagnosed with gestational diabetes regardless of birth weight. (time frame: postnatal 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06333548, which also lists 2 linked publications.
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 29 Mar 2024.