Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

NCT03583216 | Completed

• 1 other identifier: ATADEK-2017/10
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare Factor XII levels in gestational diabetic and healthy pregnancies.

Conditions

Diabetic Pregnancy; Pregnancy Related; Complement System; Disorder

Keywords

Diabetic pregnancies, Factor XII

Outcome Measures

Primary Outcomes (1)

• Factor XII level

  The primary outcome is to evaluate Factor XII level in diabetic pregnancies. If the investigators can prove that Factor XII, which has a mitogenic activity and can increase the risk for thrombosis, increases more in diabetic pregnancies in the future usage of Factor inhibitors may reduce macrosomia, thrombosis and the complications due to these conditions in diabetic pregnancies

  Blood will be drawn when the patient is hospitalized before they deliver.

Secondary Outcomes (1)

• Macrosmia

  Blood will be drawn when the patient is hospitalized before they deliver.

Study Arms (2)

Diabetic pregnancy

Pregnant patients with a diagnosis of Type I, Type II or gestational diabetes will be included in this arm. Blood will be drawn from each patient when they are hospitalized and before they deliver either vaginally or by cesarean section. Blood will be drawn into two citrate tubes, each will contain 4 ml blood.

Diagnostic Test: Diabetic pregnancy

Non-diabetic pregnancy

Healthy non-diabetic pregnant patients will be included in this arm. Blood will be drawn from each patient when they are hospitalized and before they deliver either vaginally or by cesarean section. Blood will be drawn into two citrate tubes, each will contain 4 ml blood.

Diagnostic Test: Non-diabetic pregnancy

Interventions

Diabetic pregnancy DIAGNOSTIC_TEST

Blood samples will be drawn before delivery to evaluate Factor XII level.

Diabetic pregnancy

Non-diabetic pregnancy DIAGNOSTIC_TEST

Blood samples will be drawn before delivery to evaluate Factor XII level.

Non-diabetic pregnancy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

30 Pregnant patients with a diagnosis of Type I, Type II or gestational diabetes and 30 non-diabetic pregnant patients will be included in our trial.

You may qualify if:

• Term pregnancy
• Pregnant patients with a diagnosis of Type I diabetes
• Pregnant patients with a diagnosis of Type II diabetes
• Pregnant patients with a diagnosis of Gestational diabetes
• Non-diabetic pregnancies
• Uncomplicated pregnancies

You may not qualify if:

• Preterm pregnancy
• Postterm pregnancy
• Pregnant patients with a diagnosis of systemic diseases other than diabetes
• Complicated pregnancies

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

Location

Related Publications (5)

• Schousboe I. Pharmacological regulation of factor XII activation may be a new target to control pathological coagulation. Biochem Pharmacol. 2008 Mar 1;75(5):1007-13. doi: 10.1016/j.bcp.2007.10.003. Epub 2007 Oct 7.

  PMID: 17996217 BACKGROUND

• Decrem Y, Rath G, Blasioli V, Cauchie P, Robert S, Beaufays J, Frere JM, Feron O, Dogne JM, Dessy C, Vanhamme L, Godfroid E. Ir-CPI, a coagulation contact phase inhibitor from the tick Ixodes ricinus, inhibits thrombus formation without impairing hemostasis. J Exp Med. 2009 Oct 26;206(11):2381-95. doi: 10.1084/jem.20091007. Epub 2009 Oct 5.

  PMID: 19808248 BACKGROUND

• Bryant JW, Shariat-Madar Z. Human plasma kallikrein-kinin system: physiological and biochemical parameters. Cardiovasc Hematol Agents Med Chem. 2009 Jul;7(3):234-50. doi: 10.2174/187152509789105444.

  PMID: 19689262 BACKGROUND

• Renne T, Schmaier AH, Nickel KF, Blomback M, Maas C. In vivo roles of factor XII. Blood. 2012 Nov 22;120(22):4296-303. doi: 10.1182/blood-2012-07-292094. Epub 2012 Sep 19.

  PMID: 22993391 RESULT

• Ozbasli E, Takmaz O, Karabuk E, Gungor M. Comparison of factor XII levels in gestational diabetes, fetal macrosomia, and healthy pregnancies. BMC Pregnancy Childbirth. 2020 Dec 2;20(1):752. doi: 10.1186/s12884-020-03455-0.

  PMID: 33267793 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

8ml of blood samples will be drawn from each participitant

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mete Gungor, Prof.

  Acibadem MAA University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: July 20, 2018
• Primary Completion: September 30, 2018
• Study Completion: November 30, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)