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

Primary Purpose

Gestational Diabetes, Pregnancy Related

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
selenium+ diet
only diet
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring selenium, gestational diabetes mellitus, glycemic control

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

only given diet therapy

given diet therapy and selenium

Arm Description

only diet theraphy

diet theraphy and 200 mcg selenium

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 10, 2023
Last Updated
June 27, 2023
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05823337
Brief Title
Evaluation of the Relationship Between Serum Selenium Level and Glycemic Control in Pregnant Patients*
Official Title
Evaluation of the Relationship Between Serum Selenium Level and Glycemic Control in Pregnant Patients*
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Pregnancy Related
Keywords
selenium, gestational diabetes mellitus, glycemic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
only given diet therapy
Arm Type
Active Comparator
Arm Description
only diet theraphy
Arm Title
given diet therapy and selenium
Arm Type
Experimental
Arm Description
diet theraphy and 200 mcg selenium
Intervention Type
Dietary Supplement
Intervention Name(s)
selenium+ diet
Other Intervention Name(s)
diet
Intervention Description
Selenium functions as an active site component of an antioxidant enzyme, glutathione peroxidase, and helps scavenge free radicals.
Intervention Type
Dietary Supplement
Intervention Name(s)
only diet
Intervention Description
diet suitable for pregnancy
Primary Outcome Measure Information:
Title
five day fasting glucose average
Description
five-day fasting glucose average during treatment after one month of treatment
Time Frame
four weeks
Title
five-day first hour postprandial glucose average
Description
five-day first hour postprandial glucose average during treatment after one month of treatment
Time Frame
four weeks
Title
five-day second hour postprandial glucose average
Description
five-day second hour postprandial glucose average during treatment after one month of treatment
Time Frame
four weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ece yiğit
Phone
+90 5547296609
Email
ece.yigit@medipol.edu.tr
Facility Information:
Facility Name
Medipol University
City
Istanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
medipol university
Phone
444 85 44
Email
akademik@medipol.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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