Gestational DiabetesNCT05823337
Evaluation of the Relationship Between Serum Selenium Level and Glycemic Control in Pregnant Patients*
A study testing selenium+ diet and only diet in people with Gestational Diabetes and Pregnancy Related, run by Medipol University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Pregnancy Related
- What is being tested?
- selenium+ diet and only diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol University
Istanbul
medipol university, 444 85 44, akademik@medipol.edu.tr
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes, Pregnancy Related
- Being tested
- selenium+ diet, only diet
- Keywords
- selenium, gestational diabetes mellitus, glycemic control
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selenium+ dietDietary supplement
Also called diet
Selenium functions as an active site component of an antioxidant enzyme, glutathione peroxidase, and helps scavenge free radicals.
only dietDietary supplement
diet suitable for pregnancy
| Study group | Role | What they receive |
|---|---|---|
| only given diet therapy | Active comparator | only diet theraphy Receives: Dietary Supplement: only diet |
| given diet therapy and selenium | Experimental | diet theraphy and 200 mcg selenium Receives: Dietary Supplement: selenium+ diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
five day fasting glucose average
five-day fasting glucose average during treatment after one month of treatment
Measured: four weeks
five-day first hour postprandial glucose average
five-day first hour postprandial glucose average during treatment after one month of treatment
Measured: four weeks
five-day second hour postprandial glucose average
five-day second hour postprandial glucose average during treatment after one month of treatment
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Yigit, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823337
- Sponsor's protocol ID
- gdmselenyum*
- Status last verified
- Jun 2023
- First submitted
- 10 Apr 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Serum Selenium Level and Glycemic Control in Pregnant Patients*
- ClinicalTrials.gov ID
- NCT05823337
- Acronym / sponsor ID
- gdmselenyum*
- Conditions
- Gestational Diabetes, Pregnancy Related
- Keywords
- selenium, gestational diabetes mellitus, glycemic control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| only given diet therapy | Active comparator | Dietary Supplement: only dietonly diet theraphy |
| given diet therapy and selenium | Experimental | Dietary Supplement: selenium+ dietdiet theraphy and 200 mcg selenium |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selenium+ dietAlso: dietSelenium functions as an active site component of an antioxidant enzyme, glutathione peroxidase, and helps scavenge free radicals. | Dietary supplement | given diet therapy and selenium |
| only dietdiet suitable for pregnancy | Dietary supplement | only given diet therapy |
Primary outcome
five day fasting glucose average
Time frame: four weeks
five-day fasting glucose average during treatment after one month of treatment
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selenium+ diet and only diet in people with Gestational Diabetes and Pregnancy Related, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ece yiğit (+90 5547296609, ece.yigit@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
five day fasting glucose average (time frame: four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.