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

Sponsor
Diyarbakir Women's and Children's Diseases Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03650790
Collaborator
(none)
120
1
3
3.9
30.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood test
N/A

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

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
40 obese preeclamptic pregnant women 40 non-obese preeclamptic pregnant women 40 normal pregnant women40 obese preeclamptic pregnant women 40 non-obese preeclamptic pregnant women 40 normal pregnant women
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Diyarbakir Women's and Children's Diseases Hospital
Actual Study Start Date :
Sep 3, 2018
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Active Comparator: normal pregnancy

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

Diagnostic Test: Blood 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.

Outcome Measures

Primary Outcome Measures

  1. CTRP 9 level in preeclamptic pregnancies [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 40 Years
Sexes Eligible for Study:
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:
  • A previously known chronic metabolic disease (diabetes, pregestational dyslipidemia, hypertension,)

  • collagen vascular diseases,

  • inflammatory bowel disease

  • chronic inflammatory conditions,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Diyarbakır Women's and Children's Hospital Diyarbakır Turkey 21100

Sponsors and Collaborators

  • Diyarbakir Women's and Children's Diseases Hospital

Investigators

  • Principal Investigator: Şerif Aksin, specialist, Diyarbakir Women's and Children's Diseases Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Şerif AKSİN, specialist doctor, Diyarbakir Women's and Children's Diseases Hospital
ClinicalTrials.gov Identifier:
NCT03650790
Other Study ID Numbers:
  • DiyarbakirWCDH
First Posted:
Aug 29, 2018
Last Update Posted:
Jan 8, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Şerif AKSİN, specialist doctor, Diyarbakir Women's and Children's Diseases Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 8, 2019