Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Patients with Gestational Diabetes

Официальное название

Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Pregnant Women with Gestational Diabetes Mellitus

Обзор

Our study aims to explore the influence of dietary chromium supplementation in the form of chromium picolinate, at different doses (200 µg and 400 µg per day), on the health of pregnant women with gestational diabetes. This study will also provide more information on the safety of this type of supplementation during pregnancies complicated by gestational diabetes mellitus. 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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Plasma chromium level (ng/dL) [Срок оценки: At baseline and after six weeks]
• Fasting plasma glucose level (g/L) [Срок оценки: At baseline and after six weeks]
• Plasma cholesterol level (g/L) [Срок оценки: At baseline and after six weeks]
• Plasma triglyceride level (g/L) [Срок оценки: At baseline and after six weeks]
• Plasma total antioxidant status (mmol/L) [Срок оценки: At baseline and after six weeks]
• Erythrocyte glutathione peroxidase (U/g Hb) [Срок оценки: At baseline and after six weeks]
• Erythrocyte catalase (U/g Hb) [Срок оценки: At baseline and after six weeks]
• Erythrocyte superoxide dismutase (U/g Hb) [Срок оценки: At baseline and after six weeks]
• Plasma 8-Hydroxydeoxyguanosine (ng/mL) [Срок оценки: At baseline and after six weeks]
• Erythrocye malondialdehyde (µm/L) [Срок оценки: At baseline and after six weeks]

Вторичные конечные точки (7)

• Plasma leptin level (ng/mL) [Срок оценки: At baseline and after six weeks]
• Age (year) [Срок оценки: At baseline]
• Body Weight (kg) [Срок оценки: At baseline and after six weeks]
• Height (m) [Срок оценки: At baseline]
• Body Mass Index (kg/m^2) [Срок оценки: At baseline and after six weeks]
• Plasma urea (g/L) [Срок оценки: At baseline and after six weeks]
• Plasma creatinine (mg/L) levels [Срок оценки: At baseline and after six weeks]

Критерии участия

Критерии включения

• Healthy pregnant women:

• 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.

Критерии исключения

• Pregnant women with unrecognized diabetes, type I or type II, will not be involved in this study.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Algeria · 1 центр

• Mohamed Boudiaf Hospital, Ouargla — Ouargla

Идентификаторы

NCT: NCT06860087 · EA02/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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