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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with gestational diabetes mellitus supplemented with 200 µg/day of chromium picolinate | Active Comparator | 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. |
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| Women with gestational diabetes mellitus supplemented with 400 µg/day of chromium picolinate | Active Comparator | 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. |
|
| Pregnant women with gestational diabetes mellitus (Dibetic control group) | No Intervention | 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. | |
| Healthy pregnant women (Healthy control group) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma chromium level (ng/dL) | In all groups by using Atomic Absorption Spectroscopy. | At baseline and after six weeks |
| Fasting plasma glucose level (g/L) | In all groups, by a spectrophotometric method using a commercial kit. | At baseline and after six weeks |
| Plasma cholesterol level (g/L) | In all groups, by spectrophotometric method using commercial kit. | At baseline and after six weeks |
| Plasma triglyceride level (g/L) | In all groups, by spectrophotometric method using commercial kit. | At baseline and after six weeks |
| Plasma total antioxidant status (mmol/L) | In all groups, by a spectrophotometric method using a commercial kit. | At baseline and after six weeks |
| Erythrocyte glutathione peroxidase (U/g Hb) | In all groups, by a spectrophotometric method using a commercial kit. | At baseline and after six weeks |
| Erythrocyte catalase (U/g Hb) | In all groups, by a spectrophotometric method using a commercial kit. | At baseline and after six weeks |
| Erythrocyte superoxide dismutase (U/g Hb) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma leptin level (ng/mL) | In all groups, by an immunoenzymatic method using a commercial kit. | At baseline and after six weeks |
| Age (year) | At baseline |
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Inclusion Criteria:
Healthy pregnant women:
Pregnant women with gestational diabetes mellitus:
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 biological women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadjer SAIFI, PhD in Biological Sciences | Contact | 00213 660 210 813 | saifi.hadjer@univ-ouargla.dz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohamed Boudiaf Hospital, Ouargla | Ouargla | Ouargla Province | 30000 | Algeria |
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Our study will include 04 groups:
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| Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d) | Dietary Supplement | 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. |
|
In all groups, by a spectrophotometric method using a commercial kit. |
| At baseline and after six weeks |
| Plasma 8-Hydroxydeoxyguanosine (ng/mL) | In all groups, by spectrophotometric method using commercial kit. | At baseline and after six weeks |
| Erythrocye malondialdehyde (µm/L) | In all groups, by spectrophotometric method using commercial kit. | At baseline and after six weeks |
| Erythrocyte carbonyl protein (µm/L) | In all groups, by spectrophotometric method using commercial kit. | At baseline and after six weeks |
| Plasma tumor necrosis factor-α (pg/mL) | In all groups, by spectrophotometric method using commercial kit. | At baseline and after six weeks |
| Plasma interleukin-10 (pg/mL) | In all groups, by spectrophotometric method using commercial kit. | At baseline and after six weeks |
| Plasma insulin level (µU/mL) | In all groups, by immunological method using commercial kit. | At baseline and after six weeks |
| Body Weight (kg) | Using an electronic balance | At baseline and after six weeks |
| Height (m) | 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. | At baseline and after six weeks |
| Plasma urea (g/L) | In all groups, by a spectrophotometric method using a commercial kit. | At baseline and after six weeks |
| Plasma creatinine (mg/L) levels | In all groups, by a spectrophotometric method using a commercial kit. | At baseline and after six weeks |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D007333 | Insulin Resistance |
| D044882 | Glucose Metabolism Disorders |
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
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