Pre-EclampsiaCTRPNCT03650790
C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies
A study testing Blood test in people with Pre-Eclampsia and Obesity; Endocrine, run by Diyarbakir Women's and Children's Diseases Hospital at 1 site in Turkey (Türkiye).
Trial summary
The complement C1q tumor necrosis factor-associated protein-9 (CTRP-9), which is responsible for regulating cardiovascular and metabolic functions, increases vascular relaxation by pathway dependent on AMPK / endothelial nitric oxide synthesis (eNOS). Read more about this study
- Who is it for?
- Ages 15 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Obesity; Endocrine
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2018to 1 Jan 2019
- Phase
- Interventional
- 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 15 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women who are ages 15-40
- BMI ≥35 kg/m2 and BMI<25 KG/m2 pregnants
- The clinical diagnosis of preeclampsia will follow the current criteria outlined by ACOG 10
- > 20 th weeks of pregnancy
Who cannot join
- A previously known chronic metabolic disease (diabetes, pregestational dyslipidemia, hypertension,)
- collagen vascular diseases,
- inflammatory bowel disease
- chronic inflammatory conditions,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diyarbakır Women's and Children's Hospital
Diyarbakır, 21100
About this study
Official title: Diyarbakir Women's and Children's Diseases Hospital
The complement C1q tumor necrosis factor-associated protein-9 (CTRP-9), which is responsible for regulating cardiovascular and metabolic functions, increases vascular relaxation by pathway dependent on AMPK / endothelial nitric oxide synthesis (eNOS). The aim of this study was to investigate CTRP-9 levels in pregnant women with preeclampsia.
Read the detailed description
The most important reason for the development of preeclampsia is the problem of trophoblastinvasion and consequent formation and development of placenta is not healthy
Cytokines are regulatory molecules that have effects on cell functions.Cytokines are molecules that also regulate endothelial functions. Placenta formation and widespread endothelial damage are under the influence of cytokines.
Therefore, there may be important links between impairment or imbalance in cytokine release and function and the formation of preeclampsia.Nitric oxide (NO) is a biologic enzyme that is synthesized by nitric oxide synthase (NOS) from the amino acid of L-arginine and exists in all mammals.
e(NOS) is the three isoforms of NO. It is known that NO is a major vasodilator of pregnancy, inhibiting platelet and leukocyte aggregation.There was a decrease in NO levels in preeclamptic patients.
The CqP / TNF Binding Protein (CTRP) family consists of 15 members, and is synthesized in many organs outside the body of fat.CTRP9 is predominantly excreted in fat tissue, and levels in circulation are reduced in patients with diabetes and obesity.Many studies have shown that CTRP9 exerts beneficial effects on metabolic and cardiovascular homeostasis.
CTRP9 increases vascular relaxation in the AMPK / endothelial nitric oxide synthase (eNOS) dependent pathway. CTRP9 has also been reported to reduce inflammatory responses in endothelial cells via the AMPK-dependent pathway.
Vasorelaxation due to CTRP9 is endothelium-dependent and NO-mediated. CTRP9, directly acting on smooth muscle, is indirectly or indirectly associated with NO production in the vascular endothelial layer by stimulating vasorelaxial molecular production by endothelial cells.
- Conditions
- Pre-Eclampsia, Obesity; Endocrine
- Being tested
- Blood test
- Keywords
- CTRP, Adipocytokines, pre-eclampsia
- Medical subject headings
- Pre-Eclampsia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
For serum analysis, approximately 2 cc antecubital vein venous blood serum will be taken from each patient to be studied for CTRP9 Level analysis. Adult blood will be centrifuged at 4000 rpm for 10 minutes to separate greenhouses. The obtained serum samples will be stored at -80 ° C until analysis.
| Study group | Role | What they receive |
|---|---|---|
| preeclamptic obese pregnancy | Active comparator | CTRP 9 level will be assessed by 40 obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria. Receives: Diagnostic Test: Blood test |
| preeclamptic non-obese pregnancy | Active comparator | CTRP 9 level will be assessed by 40 non-obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria. Receives: Diagnostic Test: Blood test |
| normal pregnancy | Active comparator | CTRP 9 level will be assessed by 40 normal gestational ELISA methods Receives: Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTRP 9 level in preeclamptic pregnancies
Blood samples were taken from patients with preeclampsia. The diagnosis was made when the arterial blood pressure was above 140/90 mm / Hg within 6 hours and was accompanied by proteinuria (> 300 milligrams in a sample) with high blood pressure and number of patients with proteinuria (ACOG criteria)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start3 Sep 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 obese preeclamptic pregnant women 40 non-obese preeclamptic pregnant women 40 normal pregnant women
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diyarbakir Women's and Children's Diseases Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şerif AKSİN, Diyarbakir Women's and Children's Diseases Hospital
- Investigators
- Şerif Aksin, specialist, Principal investigator, Diyarbakir Women's and Children's Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650790
- Sponsor's protocol ID
- DiyarbakirWCDH
- Acronym
- CTRP
- Status last verified
- Jan 2019
- First submitted
- 27 Aug 2018
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diyarbakir Women's and Children's Diseases Hospital
- ClinicalTrials.gov ID
- NCT03650790
- Acronym / sponsor ID
- CTRP / DiyarbakirWCDH
- Conditions
- Pre-Eclampsia, Obesity; Endocrine
- Keywords
- CTRP, Adipocytokines, pre-eclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Diyarbakir Women's and Children's Diseases HospitalUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 29 Aug 2018 (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 complement C1q tumor necrosis factor-associated protein-9 (CTRP-9), which is responsible for regulating cardiovascular and metabolic functions, increases vascular relaxation by pathway dependent on AMPK / endothelial nitric oxide synthesis (eNOS). The aim of this study was to investigate CTRP-9 levels in pregnant women with preeclampsia.
Detailed description
The most important reason for the development of preeclampsia is the problem of trophoblastinvasion and consequent formation and development of placenta is not healthy
Cytokines are regulatory molecules that have effects on cell functions.Cytokines are molecules that also regulate endothelial functions. Placenta formation and widespread endothelial damage are under the influence of cytokines.
Therefore, there may be important links between impairment or imbalance in cytokine release and function and the formation of preeclampsia.Nitric oxide (NO) is a biologic enzyme that is synthesized by nitric oxide synthase (NOS) from the amino acid of L-arginine and exists in all mammals.
e(NOS) is the three isoforms of NO. It is known that NO is a major vasodilator of pregnancy, inhibiting platelet and leukocyte aggregation.There was a decrease in NO levels in preeclamptic patients.
The CqP / TNF Binding Protein (CTRP) family consists of 15 members, and is synthesized in many organs outside the body of fat.CTRP9 is predominantly excreted in fat tissue, and levels in circulation are reduced in patients with diabetes and obesity.Many studies have shown that CTRP9 exerts beneficial effects on metabolic and cardiovascular homeostasis.
CTRP9 increases vascular relaxation in the AMPK / endothelial nitric oxide synthase (eNOS) dependent pathway. CTRP9 has also been reported to reduce inflammatory responses in endothelial cells via the AMPK-dependent pathway.
Vasorelaxation due to CTRP9 is endothelium-dependent and NO-mediated. CTRP9, directly acting on smooth muscle, is indirectly or indirectly associated with NO production in the vascular endothelial layer by stimulating vasorelaxial molecular production by endothelial cells.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 40 obese preeclamptic pregnant women 40 non-obese preeclamptic pregnant women 40 normal pregnant women
| Arm | Type | Receives |
|---|---|---|
| preeclamptic obese pregnancy | Active comparator | Diagnostic Test: Blood testCTRP 9 level will be assessed by 40 obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria. |
| preeclamptic non-obese pregnancy | Active comparator | Diagnostic Test: Blood testCTRP 9 level will be assessed by 40 non-obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria. |
| normal pregnancy | Active comparator | Diagnostic Test: Blood testCTRP 9 level will be assessed by 40 normal gestational ELISA methods |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pregnant women who are ages 15-40
- BMI ≥35 kg/m2 and BMI<25 KG/m2 pregnants
- The clinical diagnosis of preeclampsia will follow the current criteria outlined by ACOG 10
- > 20 th weeks of pregnancy
Key exclusion criteria (4 listed)
- A previously known chronic metabolic disease (diabetes, pregestational dyslipidemia, hypertension,)
- collagen vascular diseases,
- inflammatory bowel disease
- chronic inflammatory conditions,
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 |
|---|---|---|
| Blood testFor serum analysis, approximately 2 cc antecubital vein venous blood serum will be taken from each patient to be studied for CTRP9 Level analysis. Adult blood will be centrifuged at 4000 rpm for 10 minutes to separate greenhouses. The obtained serum samples will be stored at -80 ° C until analysis. | Diagnostic test | normal pregnancy, preeclamptic non-obese pregnancy, preeclamptic obese pregnancy |
Primary outcome
CTRP 9 level in preeclamptic pregnancies
Time frame: 3 months
Blood samples were taken from patients with preeclampsia. The diagnosis was made when the arterial blood pressure was above 140/90 mm / Hg within 6 hours and was accompanied by proteinuria (> 300 milligrams in a sample) with high blood pressure and number of patients with proteinuria (ACOG criteria)
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 8 Jan 2019.
- Preeclampsia relationship of adipocytokinesLink provided by the sponsor.
- Relation to CTRP 9 vasodilatationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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, specialist principal investigator
Diyarbakir Women's and Children's Diseases Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Pre-Eclampsia and Obesity; Endocrine, run by Diyarbakir Women's and Children's Diseases 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 4 inclusion and 4 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 8 Jan 2019. 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?
CTRP 9 level in preeclamptic pregnancies (time frame: 3 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 8 Jan 2019.