Insulin SensitivityNCT01363622
Vaspin Levels Compared With Serum Insulin and Blood Glucose Levels in Neonates
An observational study of Insulin Sensitivity, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate circulating concentrations of vaspin in fetal and neonatal samples from SGA, AGA and LGA with the respective insulin concentrations. Serum vaspin concentrations were determined by enzyme immunoassay in 22 SGA and 30 LGA and 30 AGA singleton full-term fetuses and neonates on… Read more about this study
- Who is it for?
- Ages 1 day to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2010to Jul 2011
- 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 day to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: SGA infant LGA infant AGA infant
Who may be able to join
- Full term healthy infant
Who cannot join
- sepsis
- congenital anomaly
- sick infant
Trial locations and contacts
1 site in 1 country.
Ahmet Akcay, MD contact
Mehmet Yekta Öncel, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, 06600
Ahmet Akcay, MD, ahmet1906ak@windowslive.com
About this study
Official title: Zekai Tahir Burak Maternity Teaching Hospital
The aim of this study was to investigate circulating concentrations of vaspin in fetal and neonatal samples from SGA, AGA and LGA with the respective insulin concentrations. Serum vaspin concentrations were determined by enzyme immunoassay in 22 SGA and 30 LGA and 30 AGA singleton full-term fetuses and neonates on cord blood and postnatal day 5.
- Conditions
- Insulin Sensitivity
- Keywords
- Vaspin, LGA, SGA, Insulin, Blood glucose
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SGA | SGA (small for gestational age) | |
| LGA | LGA (large for gestational age) | |
| AGA | AGA (appropriate-for-gestational-age) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363622
- Sponsor's protocol ID
- ZTB061
- Status last verified
- Mar 2011
- First submitted
- 27 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zekai Tahir Burak Maternity Teaching Hospital
- ClinicalTrials.gov ID
- NCT01363622
- Acronym / sponsor ID
- ZTB061
- Conditions
- Insulin Sensitivity
- Keywords
- Vaspin, LGA, SGA, Insulin, Blood glucose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 1 Jun 2011 (estimated)
- 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 aim of this study was to investigate circulating concentrations of vaspin in fetal and neonatal samples from SGA, AGA and LGA with the respective insulin concentrations. Serum vaspin concentrations were determined by enzyme immunoassay in 22 SGA and 30 LGA and 30 AGA singleton full-term fetuses and neonates on cord blood and postnatal day 5.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SGA | – | –SGA (small for gestational age) |
| LGA | – | –LGA (large for gestational age) |
| AGA | – | –AGA (appropriate-for-gestational-age) |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- SGA infant LGA infant AGA infant
Key inclusion criteria (1 listed)
- Full term healthy infant
Key exclusion criteria (3 listed)
- sepsis
- congenital anomaly
- sick infant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
Related trials for Insulin Sensitivity
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
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.
Ahmet Akcay, MD contact
Mehmet Yekta Öncel, MD contact
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 Insulin Sensitivity, run by Zekai Tahir Burak Women's Health Research and Education 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 1 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: status not confirmed, as of the sponsor's last update on 2 Jun 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Akcay, MD (ahmet1906ak@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 2 Jun 2011.