C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies (CTRP)
Primary Purpose
Pre-Eclampsia, Obesity; Endocrine
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Blood test
Sponsored by
About this trial
This is an interventional prevention trial for Pre-Eclampsia focused on measuring CTRP, Adipocytokines, pre-eclampsia
Eligibility Criteria
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,
Sites / Locations
- Diyarbakır Women's and Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
preeclamptic obese pregnancy
preeclamptic non-obese pregnancy
normal pregnancy
Arm Description
CTRP 9 level will be assessed by 40 obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria.
CTRP 9 level will be assessed by 40 non-obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria.
CTRP 9 level will be assessed by 40 normal gestational ELISA methods
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03650790
First Posted
August 27, 2018
Last Updated
January 5, 2019
Sponsor
Diyarbakir Women's and Children's Diseases Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03650790
Brief Title
C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies
Acronym
CTRP
Official Title
Diyarbakir Women's and Children's Diseases Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diyarbakir Women's and Children's Diseases Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Obesity; Endocrine
Keywords
CTRP, Adipocytokines, pre-eclampsia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
40 obese preeclamptic pregnant women 40 non-obese preeclamptic pregnant women 40 normal pregnant women
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preeclamptic obese pregnancy
Arm Type
Active Comparator
Arm Description
CTRP 9 level will be assessed by 40 obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria.
Arm Title
preeclamptic non-obese pregnancy
Arm Type
Active Comparator
Arm Description
CTRP 9 level will be assessed by 40 non-obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria.
Arm Title
normal pregnancy
Arm Type
Active Comparator
Arm Description
CTRP 9 level will be assessed by 40 normal gestational ELISA methods
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood test
Intervention Description
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.
Primary Outcome Measure Information:
Title
CTRP 9 level in preeclamptic pregnancies
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şerif Aksin, specialist
Organizational Affiliation
Diyarbakir Women's and Children's Diseases Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diyarbakır Women's and Children's Hospital
City
Diyarbakır
ZIP/Postal Code
21100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/21836066
Description
Preeclampsia relationship of adipocytokines
URL
https://www.ncbi.nlm.nih.gov/pubmed/30103635
Description
Relation to CTRP 9 vasodilatation
Learn more about this trial
C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies
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