Evaluation of the Relationship Between Serum Selenium Level and Glycemic Control in Pregnant Patients*

Pregnancy Related Clinical Trial

Official title:

Evaluation of the Relationship Between Serum Selenium Level and Glycemic Control in Pregnant Patients*

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05823337
• Other study ID #: gdmselenyum*
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2023
• Source: Medipol University
• Contact: ece yigit
• Phone: +90 5547296609
• Email: ece.yigit[@]medipol.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gestational diabetes mellitus (GDM) occurs in approximately 15% of all pregnancies worldwide.GDM can lead to the development of type 2 diabetes mellitus (T2DM) later in a woman's life. Babies of mothers with GDM have a greater risk of developing T2DM and cardiovascular disease than infants of women without GDM. The degree of insulin resistance is directly proportional to the accumulated free radicals. Selenium functions as an active site component of an antioxidant enzyme, glutathione peroxidase, and helps scavenge free radicals. In addition, an experimental study has shown that selenium provides activation by binding to insulin receptors and lowers blood sugar by increasing glucose uptake by cells.

According to all this information, we aimed to evaluate the effect of selenium on blood sugar regulation in pregnant patients.

Description:

Pregnant patients with no known chronic disease / drug use and who had an oral glucose tolerance test between 24 and 28 weeks of gestation will be included in our study. The presence of one or more of the fasting blood glucose values ≥ 92, 1st Hour ≥ 180 and 2nd Hour ≥ 153 will be considered as gestational diabetes. Our patients diagnosed with gestational diabetes in the second step will be divided into two groups.

The first group will be started with diet only, the second group diet + 200 mcg selenium supplement per day. Patients will continue these treatments for 4 weeks, and at the end of 4 weeks, they will follow their fingertip blood sugar for 5 days (fasting, 1st hour satiety and 2nd hour satiety) while the treatment continues. In patients with gestational diabetes diagnosis, our targets for fingertip blood glucose follow-ups at home are fasting <95, 1st hour <140, 2nd hour <120.

The 5-day measurements of both groups will be averaged for fasting, 1st Hour and 2nd Hour, and it will be evaluated whether there is a significant difference in blood sugar regulation between the groups that take selenium supplements and those that do not.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: August 31, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Presence of one or more of the values of fasting blood glucose = 92, 1st hour = 180 and 2nd hour = 153 among pregnant patients for whom we had an oral glucose tolerance test between 24 and 28 weeks of gestation

• single pregnancy

• 18 to 45 years old

Exclusion Criteria:

• chronic disease (thyroid dysfunction, acute/chronic liver disease, acute/chronic kidney disease, hypertension )

• Patients with a diagnosis of insulin resistance or diabetes

• Those who use drugs other than iron, vitamin D and multivitamin support

• multiple pregnancy

• patients under 18 years old

• Patients over 45 years old

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy Related

Intervention

Dietary Supplement:
• selenium+ diet
Selenium functions as an active site component of an antioxidant enzyme, glutathione peroxidase, and helps scavenge free radicals.
• only diet
diet suitable for pregnancy

Locations

Country	Name	City	State
Turkey	Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	five day fasting glucose average	five-day fasting glucose average during treatment after one month of treatment	four weeks
Primary	five-day first hour postprandial glucose average	five-day first hour postprandial glucose average during treatment after one month of treatment	four weeks
Primary	five-day second hour postprandial glucose average	five-day second hour postprandial glucose average during treatment after one month of treatment	four weeks