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

June 27, 2023 updated by: Ece Yigit, Medipol University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
five day fasting glucose average
Time Frame: four weeks
five-day fasting glucose average during treatment after one month of treatment
four weeks
five-day first hour postprandial glucose average
Time Frame: four weeks
five-day first hour postprandial glucose average during treatment after one month of treatment
four weeks
five-day second hour postprandial glucose average
Time Frame: four weeks
five-day second hour postprandial glucose average during treatment after one month of treatment
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

August 30, 2023

Study Completion (Estimated)

August 31, 2023

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gdmselenyum*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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