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

NCT05823337 | Unknown

• 1 other identifier: gdmselenyum*
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Pregnancy Related

Keywords

selenium; gestational diabetes mellitus; glycemic control

Outcome Measures

Primary Outcomes (3)

• five day fasting glucose average

  five-day fasting glucose average during treatment after one month of treatment

  four weeks

• five-day first hour postprandial glucose average

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

  four weeks

• five-day second hour postprandial glucose average

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

  four weeks

Study Arms (2)

only given diet therapy

ACTIVE COMPARATOR

only diet theraphy

Dietary Supplement: only diet

given diet therapy and selenium

EXPERIMENTAL

diet theraphy and 200 mcg selenium

Dietary Supplement: selenium+ diet

Interventions

selenium+ diet DIETARY_SUPPLEMENT

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

Also known as: diet

given diet therapy and selenium

only diet DIETARY_SUPPLEMENT

diet suitable for pregnancy

only given diet therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 45 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Diet

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

ece yiğit

CONTACT

+90 5547296609; ece.yigit@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.prof. Ece YİĞİT

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: July 1, 2023
• Primary Completion: August 30, 2023
• Study Completion: August 31, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

TU (1)