A Phase 1/2 interventional study of Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d) and Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d) in Gestational Diabetes Mellitus (GDM), Oxidative Stress and Inflammatory Status, sponsored by University of Kasdi Merbah. Not yet recruiting at 1 site in Algeria. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by University of Kasdi Merbah · Phase 1/2, Interventional, and Supportive care
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:
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.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 200 is above the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →This is the only study on the registry with University of Kasdi Merbah as lead sponsor.
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Healthy pregnant women:
Pregnant women with gestational diabetes mellitus:
Exclusion Criteria:
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.
Dietary Supplement: 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 400 µg of chromium picolinate (Nutraxin, B'IOTA Laboratories, Istanbul, Turquie) per day for 06 weeks.
Dietary Supplement: 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 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.
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.
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.
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
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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