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NCT Number: NCT06860087

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorder Glucose Metabolism Disorders Hyperinsulinism Inflammatory Status Insulin Resistance Leptin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mohamed Boudiaf Hospital, Ouargla

Ouargla, Ouargla Province, 30000, Algeria

Location contact

Nadira Benabdelkader, Doctorate in Medicine

CONTACT

[email protected]

00213 663 598 199

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Plasma chromium level (ng/dL)

    Time frame: At baseline and after six weeks

    In all groups by using Atomic Absorption Spectroscopy.

  2. Fasting plasma glucose level (g/L)

    Time frame: At baseline and after six weeks

    In all groups, by a spectrophotometric method using a commercial kit.

  3. Plasma cholesterol level (g/L)

    Time frame: At baseline and after six weeks

    In all groups, by spectrophotometric method using commercial kit.

  4. Plasma triglyceride level (g/L)

    Time frame: At baseline and after six weeks

    In all groups, by spectrophotometric method using commercial kit.

  5. Plasma total antioxidant status (mmol/L)

    Time frame: At baseline and after six weeks

    In all groups, by a spectrophotometric method using a commercial kit.

  6. Erythrocyte glutathione peroxidase (U/g Hb)

    Time frame: At baseline and after six weeks

    In all groups, by a spectrophotometric method using a commercial kit.

  7. Erythrocyte catalase (U/g Hb)

    Time frame: At baseline and after six weeks

    In all groups, by a spectrophotometric method using a commercial kit.

  8. Erythrocyte superoxide dismutase (U/g Hb)

    Time frame: At baseline and after six weeks

    In all groups, by a spectrophotometric method using a commercial kit.

  9. Plasma 8-Hydroxydeoxyguanosine (ng/mL)

    Time frame: At baseline and after six weeks

    In all groups, by spectrophotometric method using commercial kit.

  10. Erythrocye malondialdehyde (µm/L)

    Time frame: At baseline and after six weeks

    In all groups, by spectrophotometric method using commercial kit.

  11. Erythrocyte carbonyl protein (µm/L)

    Time frame: At baseline and after six weeks

    In all groups, by spectrophotometric method using commercial kit.

  12. Plasma tumor necrosis factor-α (pg/mL)

    Time frame: At baseline and after six weeks

    In all groups, by spectrophotometric method using commercial kit.

  13. Plasma interleukin-10 (pg/mL)

    Time frame: At baseline and after six weeks

    In all groups, by spectrophotometric method using commercial kit.

  14. Plasma insulin level (µU/mL)

    Time frame: At baseline and after six weeks

    In all groups, by immunological method using commercial kit.

Secondary outcomes

  1. Plasma leptin level (ng/mL)

    Time frame: At baseline and after six weeks

    In all groups, by an immunoenzymatic method using a commercial kit.

  2. Age (year)

    Time frame: At baseline

  3. Body Weight (kg)

    Time frame: At baseline and after six weeks

    Using an electronic balance

  4. Height (m)

    Time frame: At baseline

  5. Body Mass Index (kg/m^2)

    Time frame: At baseline and after six weeks

    Body mass index is a numerical value calculated using body weight (kg) and height (m) to determine whether they are suitable.

  6. Plasma urea (g/L)

    Time frame: At baseline and after six weeks

    In all groups, by a spectrophotometric method using a commercial kit.

  7. Plasma creatinine (mg/L) levels

    Time frame: At baseline and after six weeks

    In all groups, by a spectrophotometric method using a commercial kit.

Study contacts

Contact information is provided by the study sponsor or research team.

Hadjer SAIFI, PhD in Biological Sciences

CONTACT

[email protected]

00213 660 210 813

Sponsors and collaborators

Lead sponsor

University of Kasdi Merbah

Other

Registry information

Official study title

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

Acronym: Cr and GDM

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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