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

Sponsor

Medipol University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05823337

Collaborator

(none)

220

Enrollment

Location

Arms

Anticipated Duration (Months)

109.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Pregnancy Related	Dietary Supplement: selenium+ diet Dietary Supplement: only diet	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 20, 2023

Anticipated Primary Completion Date :

Jun 20, 2023

Anticipated Study Completion Date :

Jun 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: only given diet therapy only diet theraphy	Dietary Supplement: only diet diet suitable for pregnancy
Experimental: given diet therapy and selenium diet theraphy and 200 mcg selenium	Dietary Supplement: selenium+ diet Selenium functions as an active site component of an antioxidant enzyme, glutathione peroxidase, and helps scavenge free radicals. Other Names: diet

Arm

Intervention/Treatment

Active Comparator: only given diet therapy

only diet theraphy

Dietary Supplement: only diet

diet suitable for pregnancy

Experimental: given diet therapy and selenium

diet theraphy and 200 mcg selenium

Dietary Supplement: selenium+ diet

Selenium functions as an active site component of an antioxidant enzyme, glutathione peroxidase, and helps scavenge free radicals.

Other Names:

diet

Outcome Measures

Primary Outcome Measures

five day fasting glucose average [four weeks]
five-day fasting glucose average during treatment after one month of treatment
five-day first hour postprandial glucose average [four weeks]
five-day first hour postprandial glucose average during treatment after one month of treatment
five-day second hour postprandial glucose average [four weeks]
five-day second hour postprandial glucose average during treatment after one month of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medipol University	Istanbul		Turkey

Sponsors and Collaborators

Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ece Yigit, Ass. Dr. Ece YİĞİT, Medipol University

ClinicalTrials.gov Identifier:

NCT05823337

Other Study ID Numbers:

gdmselenyum*

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ece Yigit, Ass. Dr. Ece YİĞİT, Medipol University

selenium

gestational diabetes mellitus

glycemic control

Additional relevant MeSH terms:

Diabetes, Gestational

Selenium

Study Results

No Results Posted as of Apr 21, 2023