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

NCT06860087 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: EA02/2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (7)

• Plasma leptin level (ng/mL)

  At baseline and after six weeks

• Age (year)

  At baseline

• Body Weight (kg)

  At baseline and after six weeks

• Height (m)

  At baseline

• Body Mass Index (kg/m^2)

  At baseline and after six weeks

Study Arms (4)

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.

Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d)

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.

Dietary Supplement: Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d)

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.

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.

Women with gestational diabetes mellitus supplemented with 200 µg/day of chromium picolinate

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.

Women with gestational diabetes mellitus supplemented with 400 µg/day of chromium picolinate

Eligibility Criteria

• Gender Eligibility Details: Pregnant biological women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kasdi Merbah: lead

Study Sites (1)

Mohamed Boudiaf Hospital, Ouargla

Ouargla, Ouargla Province, 30000, Algeria

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance; Glucose Metabolism Disorders; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Central Study Contacts

Hadjer SAIFI, PhD in Biological Sciences

CONTACT

00213 660 210 813; saifi.hadjer@univ-ouargla.dz

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Biological Sciences, University Lecturer

Model Details: 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)

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: March 5, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

AL (1)