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

Sponsor
University of Kasdi Merbah
Study ID
NCT06860087
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gestational Diabetes Mellitus (GDM)
  • Glucose Metabolism Disorder
  • Inflammatory Status
  • Insulin Resistance
  • Leptin Resistance
  • Lipid Metabolism Disorders
  • Oxidative Stress

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Mar 5, 2025
Start date
May 31, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Women with gestational diabetes mellitus supplemented with 200 µg/day of chromium picolinate
    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.
  • Active Comparator: Women with gestational diabetes mellitus supplemented with 400 µg/day of chromium picolinate
    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.
  • No Intervention: Pregnant women with gestational diabetes mellitus (Dibetic control group)
    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.
  • No Intervention: Healthy pregnant women (Healthy control group)
    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.

Primary Outcome Measure

Plasma chromium level (ng/dL) [ Time Frame: At baseline and after six weeks ]

Central Contacts

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