Clinical trial NCT06860087: Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Patients with Gestational Diabetes
Official title: Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Pregnant Women with Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gestational Diabetes Mellitus (GDM)
Oxidative Stress
Inflammatory Status
Insulin Resistance
Leptin Resistance
Glucose Metabolism Disorder
Lipid Metabolism Disorders
Keywords: Inflammatory status markers
Oxidative stress markers
Glucido-lipidic metabolism
HOMA-IR
Leptin level
Lipid profile
Fasting plasma glucose
Insulin level
Lead sponsor: University of Kasdi Merbah
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our study will include 04 groups:

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)
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Plasma chromium level (ng/dL)
timeFrame: At baseline and after six weeks
measure: Fasting plasma glucose level (g/L)
timeFrame: At baseline and after six weeks
measure: Plasma cholesterol level (g/L)
timeFrame: At baseline and after six weeks
measure: Plasma triglyceride level (g/L)
timeFrame: At baseline and after six weeks
measure: Plasma total antioxidant status (mmol/L)
timeFrame: At baseline and after six weeks
measure: Erythrocyte glutathione peroxidase (U/g Hb)
timeFrame: At baseline and after six weeks
measure: Erythrocyte catalase (U/g Hb)
timeFrame: At baseline and after six weeks
measure: Erythrocyte superoxide dismutase (U/g Hb)
timeFrame: At baseline and after six weeks
measure: Plasma 8-Hydroxydeoxyguanosine (ng/mL)
timeFrame: At baseline and after six weeks
measure: Erythrocye malondialdehyde (µm/L)
timeFrame: At baseline and after six weeks
measure: Erythrocyte carbonyl protein (µm/L)
timeFrame: At baseline and after six weeks
measure: Plasma tumor necrosis factor-α (pg/mL)
timeFrame: At baseline and after six weeks
measure: Plasma interleukin-10 (pg/mL)
timeFrame: At baseline and after six weeks
measure: Plasma insulin level (µU/mL)
timeFrame: At baseline and after six weeks
Secondary outcomes:
measure: Plasma leptin level (ng/mL)
timeFrame: At baseline and after six weeks
measure: Age (year)
timeFrame: At baseline
measure: Body Weight (kg)
timeFrame: At baseline and after six weeks
measure: Height (m)
timeFrame: At baseline
measure: Body Mass Index (kg/m^2)
timeFrame: At baseline and after six weeks
measure: Plasma urea (g/L)
timeFrame: At baseline and after six weeks
measure: Plasma creatinine (mg/L) levels
timeFrame: At baseline and after six weeks
Other outcomes:
Locations:
city: Ouargla
country: Algeria
facility: Mohamed Boudiaf Hospital, Ouargla
Study officials:
References: