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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
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.
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.
Mohamed Boudiaf Hospital, Ouargla
Ouargla, Ouargla Province, Algeria
Plasma chromium level (ng/dL)
In all groups by using Atomic Absorption Spectroscopy.
Time frame: At baseline and after six weeks
Fasting plasma glucose level (g/L)
In all groups, by a spectrophotometric method using a commercial kit.
Time frame: At baseline and after six weeks
Plasma cholesterol level (g/L)
In all groups, by spectrophotometric method using commercial kit.
Time frame: At baseline and after six weeks
Plasma triglyceride level (g/L)
In all groups, by spectrophotometric method using commercial kit.
Time frame: At baseline and after six weeks
Plasma total antioxidant status (mmol/L)
In all groups, by a spectrophotometric method using a commercial kit.
Time frame: At baseline and after six weeks
Erythrocyte glutathione peroxidase (U/g Hb)
In all groups, by a spectrophotometric method using a commercial kit.
Time frame: At baseline and after six weeks
Erythrocyte catalase (U/g Hb)
In all groups, by a spectrophotometric method using a commercial kit.
Time frame: At baseline and after six weeks
Erythrocyte superoxide dismutase (U/g Hb)
In all groups, by a spectrophotometric method using a commercial kit.
Time frame: At baseline and after six weeks
Plasma 8-Hydroxydeoxyguanosine (ng/mL)
In all groups, by spectrophotometric method using commercial kit.
Time frame: At baseline and after six weeks
Erythrocye malondialdehyde (µm/L)
In all groups, by spectrophotometric method using commercial kit.
Time frame: At baseline and after six weeks
Erythrocyte carbonyl protein (µm/L)
In all groups, by spectrophotometric method using commercial kit.
Time frame: At baseline and after six weeks
Plasma tumor necrosis factor-α (pg/mL)
In all groups, by spectrophotometric method using commercial kit.
Time frame: At baseline and after six weeks
Plasma interleukin-10 (pg/mL)
In all groups, by spectrophotometric method using commercial kit.
Time frame: At baseline and after six weeks
Plasma insulin level (µU/mL)
In all groups, by immunological method using commercial kit.
Time frame: At baseline and after six weeks
Plasma leptin level (ng/mL)
In all groups, by an immunoenzymatic method using a commercial kit.
Time frame: At baseline and after six weeks
Age (year)
Time frame: At baseline
Body Weight (kg)
Using an electronic balance
Time frame: At baseline and after six weeks
Height (m)
Time frame: At baseline
Body Mass Index (kg/m^2)
Body mass index is a numerical value calculated using body weight (kg) and height (m) to determine whether they are suitable.
Time frame: At baseline and after six weeks
Plasma urea (g/L)
In all groups, by a spectrophotometric method using a commercial kit.
Time frame: At baseline and after six weeks
Plasma creatinine (mg/L) levels
In all groups, by a spectrophotometric method using a commercial kit.
Time frame: At baseline and after six weeks
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