Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Patients with Gestational Diabetes
NCT ID: NCT06860087
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2025-05-31
2026-01-31
Brief Summary
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The main questions it aims to answer are:
* Does chromium supplementation at various doses in women with gestational diabetes mellitus truly influence their glucido-lipidic metabolism, oxidative/antioxidant balance, and inflammatory state? If so, is it beneficial or detrimental?
* If this supplementation is beneficial, which dose is the most appropriate?
* Do these types of supplementation have any side effects on the health of the mother and fetus? The participants will take chromium supplements for 6 weeks (supplemented groups) while the control participants will not take them (healthy and diabetic control groups).
Chromium-supplemented participants will undergo a medical check-up every 02 weeks to closely monitor their health status and detect any potential side effects at an early stage.
Researchers will compare the biochemical profile, oxidative stress status, and inflammation markers between chromium-supplemented and non-supplemented participants to assess the impact of this trace element.
Researchers will compare the effects of chromium supplements at different doses with each other.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Group of pregnant women with gestational diabetes supplemented with 200 µg/day of chromium picolinate
2. Group of pregnant women with gestational diabetes supplemented with 400 µg/day of chromium picolinate
3. Group of pregnant women with gestational diabetes not supplemented (diabetic control group)
4. Group of healthy pregnant women not supplemented (healthy control group)
SUPPORTIVE_CARE
NONE
Study Groups
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Women with gestational diabetes mellitus supplemented with 200 µg/day of chromium picolinate
50 Pregnant women with gestational diabetes mellitus will receive an oral supplementation of 200 µg of chromium picolinate (Nutraxin, B'IOTA Laboratories, Istanbul, Turquie) per day for 06 weeks.
Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d)
50 Pregnant women with gestational diabetes mellitus will receive an oral supplementation of 200 µg of chromium picolinate (Nutraxin, B'IOTA Laboratories, Istanbul, Turquie) per day for 06 weeks, starting from their 28th week of pregnancy. 02 fasting blood samples will be taken: one just before the supplementation begins and the other upon its completion, to assess biomarkers of glucose and lipid metabolism, oxidative stress, and inflammation.
Women with gestational diabetes mellitus supplemented with 400 µg/day of chromium picolinate
50 Pregnant women with gestational diabetes mellitus will receive an oral supplementation of 400 µg of chromium picolinate (Nutraxin, B'IOTA Laboratories, Istanbul, Turquie) per day for 06 weeks.
Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d)
50 Pregnant women with gestational diabetes mellitus will receive an oral supplementation of 400 µg of chromium picolinate (Nutraxin, B'IOTA Laboratories, Istanbul, Turquie) per day for 06 weeks, starting from their 28th week of pregnancy. 02 fasting blood samples will be taken: one just before the supplementation begins and the other upon its completion, to assess biomarkers of glucose and lipid metabolism, oxidative stress, and inflammation.
Pregnant women with gestational diabetes mellitus (Dibetic control group)
50 pregnant women with gestational diabetes who will not take any supplements will undergo two fasting blood draws. One during the 28th week of pregnancy and the other at the end of the 34th week, to assess biomarkers of glucose and lipid metabolism, oxidative stress, and inflammation.
No interventions assigned to this group
Healthy pregnant women (Healthy control group)
50 healthy pregnant women who will not take any supplements will undergo two fasting blood draws. one during the 28th week of pregnancy and the other at the end of the 34th week, to assess biomarkers of glucose and lipid metabolism, oxidative stress, and inflammation.
No interventions assigned to this group
Interventions
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Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d)
50 Pregnant women with gestational diabetes mellitus will receive an oral supplementation of 200 µg of chromium picolinate (Nutraxin, B'IOTA Laboratories, Istanbul, Turquie) per day for 06 weeks, starting from their 28th week of pregnancy. 02 fasting blood samples will be taken: one just before the supplementation begins and the other upon its completion, to assess biomarkers of glucose and lipid metabolism, oxidative stress, and inflammation.
Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d)
50 Pregnant women with gestational diabetes mellitus will receive an oral supplementation of 400 µg of chromium picolinate (Nutraxin, B'IOTA Laboratories, Istanbul, Turquie) per day for 06 weeks, starting from their 28th week of pregnancy. 02 fasting blood samples will be taken: one just before the supplementation begins and the other upon its completion, to assess biomarkers of glucose and lipid metabolism, oxidative stress, and inflammation.
Eligibility Criteria
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Inclusion Criteria
* Whose their gestational age is 28 weeks
* They have no pathology or complication associated with their pregnancy.
* Pregnant women with gestational diabetes mellitus:
* They will be selected according to the criteria of the one-step method for screening for gestational diabetes mellitus established by the WHO.
* They have no other pathology or complication associated with pregnancy.
* They are subjected to insulin therapy and a low-calorie diet, rich in protein, fiber and beneficial lipids (they will all asked to keep their medical treatment prescribed by their doctor).
* All women involved in this study will be systematically supplemented with 60 mg/d iron and 400 mg/d vitamin B9 during pregnancy as recommended by WHO.
Exclusion Criteria
* Pregnant women who were supplemented before one month or during pregnancy, or who will need other micronutrient supplements during the study to avoid their influence on the results.
* Pregnant women who develop other health complications will be removed from the study and replaced by others.
* Women with gestational diabetes mellitus who were unable to complete chromium supplementation up to 6 weeks will be excluded from the study and replaced by others.
FEMALE
Yes
Sponsors
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University of Kasdi Merbah
OTHER
Responsible Party
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Hadjer SAIFI
Doctor of Biological Sciences, University Lecturer
Locations
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Mohamed Boudiaf Hospital, Ouargla
Ouargla, Ouargla Province, Algeria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EA02/2025
Identifier Type: -
Identifier Source: org_study_id
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