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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insulin Resistance; Lipid Metabolism Disorders; Oxidative Stress; Inflammatory Status; Gestational Diabetes Mellitus (GDM); Glucose Metabolism Disorder; Leptin Resistance
• Intervention / Treatment: Dietary supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d); Dietary supplement: Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hadjer SAIFI, PhD in Biological Sciences; Phone Number: 00213 660 210 813; Email: saifi.hadjer@univ-ouargla.dz

Study Locations

• Algeria
  • Ouargla, Algeria, 30000
    • Mohamed Boudiaf Hospital, Ouargla
    • Contact: Nadira Benabdelkader, Doctorate in Medicine; Phone Number: 00213 663 598 199; Email: maya-mayar25@outlook.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 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.
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.	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 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Kasdi Merbah

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: March 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Oxidative stress markers; Lipid profile; HOMA-IR; Fasting plasma glucose; Inflammatory status markers; Glucido-lipidic metabolism; Leptin level; Insulin level
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hyperinsulinism; Diabetes, Gestational; Diabetes Mellitus; Insulin Resistance; Metabolic Diseases; Lipid Metabolism Disorders; Glucose Metabolism Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Trace Elements; Micronutrients; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Chromium; Picolinic acid
• Other Study ID Numbers: EA02/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No