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CompletedNCT03650790CTRPUpdated Jan 8, 2019

C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies

An interventional study of Blood test in Pre-Eclampsia and Obesity; Endocrine, sponsored by Diyarbakir Women's and Children's Diseases Hospital. Completed at 1 site in Turkey. Open to female participants aged 15 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-08.

Sponsored by Diyarbakir Women's and Children's Diseases Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
15 Years to 40 Years
Sex
Female
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Study 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). 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.

02

Conditions studied

  • Pre-Eclampsia
  • Obesity; Endocrine

Keywords

  • CTRP
  • Adipocytokines
  • pre-eclampsia
03

In context

Eclampsia

328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.

This study's enrollment of 120 is close to the median of 120 across 169 interventional studies indexed under Eclampsia.

Browse Eclampsia studies →

Lead sponsor

Diyarbakir Women's and Children's Diseases Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • A previously known chronic metabolic disease (diabetes, pregestational dyslipidemia, hypertension,)
  • collagen vascular diseases,
  • inflammatory bowel disease
  • chronic inflammatory conditions,
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    preeclamptic obese pregnancy

    CTRP 9 level will be assessed by 40 obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria.

    Diagnostic Test: Blood test

  • Active comparator
    preeclamptic non-obese pregnancy

    CTRP 9 level will be assessed by 40 non-obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria.

    Diagnostic Test: Blood test

  • Active comparator
    normal pregnancy

    CTRP 9 level will be assessed by 40 normal gestational ELISA methods

    Diagnostic Test: Blood test

Interventions

  • Diagnostic testBlood 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 months

07

Study locations

1 site
  • Diyarbakır Women's and Children's Hospital
    Diyarbakır, 21100, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03650790
Lead sponsor
Diyarbakir Women's and Children's Diseases Hospital
Responsible party
Şerif AKSİN (specialist doctor, Diyarbakir Women's and Children's Diseases Hospital) — Principal investigator
First posted
Aug 29, 2018
Start date
Sep 3, 2018
Primary completion
Jan 1, 2019
Completion
Jan 1, 2019
Last update
Jan 8, 2019

Study contacts

Şerif Aksin, specialist
principal investigator · Diyarbakir Women's and Children's Diseases Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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