Gestational Diabetes Mellitus (GDM)Phase 1/2Cr and GDMNCT06860087
Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Patients with Gestational Diabetes
A Phase 1/2 study testing Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d) and Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d) in people with Gestational Diabetes Mellitus (GDM) and Oxidative Stress, run by University of Kasdi Merbah at 1 site in Algeria.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Oxidative Stress, Inflammatory Status
- What is being tested?
- Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d) and Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAlgeria
- Study dates
- May 2025to Jan 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Algeria1 site
Mohamed Boudiaf Hospital, Ouargla
Ouargla, Ouargla Province, 30000
Nadira Benabdelkader, Doctorate in Medicine, 00213 663 598 199, maya-mayar25@outlook.fr
About this study
Official title: 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:
Read more
- 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
- Being tested
- Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d), Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d)
- Keywords
- Inflammatory status markers, Oxidative stress markers, Glucido-lipidic metabolism, HOMA-IR, Leptin level, Lipid profile, Fasting plasma glucose, Insulin level
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance, Glucose Metabolism Disorders, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma chromium level (ng/dL)
In all groups by using Atomic Absorption Spectroscopy.
Measured: At baseline and after six weeks
Fasting plasma glucose level (g/L)
In all groups, by a spectrophotometric method using a commercial kit.
Measured: At baseline and after six weeks
Plasma cholesterol level (g/L)
In all groups, by spectrophotometric method using commercial kit.
Measured: At baseline and after six weeks
Plasma triglyceride level (g/L)
In all groups, by spectrophotometric method using commercial kit.
Measured: At baseline and after six weeks
Plasma total antioxidant status (mmol/L)
In all groups, by a spectrophotometric method using a commercial kit.
Measured: At baseline and after six weeks
Erythrocyte glutathione peroxidase (U/g Hb)
In all groups, by a spectrophotometric method using a commercial kit.
Measured: At baseline and after six weeks
Erythrocyte catalase (U/g Hb)
In all groups, by a spectrophotometric method using a commercial kit.
Measured: At baseline and after six weeks
Erythrocyte superoxide dismutase (U/g Hb)
In all groups, by a spectrophotometric method using a commercial kit.
Measured: At baseline and after six weeks
Plasma 8-Hydroxydeoxyguanosine (ng/mL)
In all groups, by spectrophotometric method using commercial kit.
Measured: At baseline and after six weeks
Erythrocye malondialdehyde (µm/L)
In all groups, by spectrophotometric method using commercial kit.
Measured: At baseline and after six weeks
Erythrocyte carbonyl protein (µm/L)
In all groups, by spectrophotometric method using commercial kit.
Measured: At baseline and after six weeks
Plasma tumor necrosis factor-α (pg/mL)
In all groups, by spectrophotometric method using commercial kit.
Measured: At baseline and after six weeks
Plasma interleukin-10 (pg/mL)
In all groups, by spectrophotometric method using commercial kit.
Measured: At baseline and after six weeks
Plasma insulin level (µU/mL)
In all groups, by immunological method using commercial kit.
Measured: At baseline and after six weeks
Secondary outcomes (7)
Plasma leptin level (ng/mL)
In all groups, by an immunoenzymatic method using a commercial kit.
Measured: At baseline and after six weeks
Age (year)
Measured: At baseline
Body Weight (kg)
Using an electronic balance
Measured: At baseline and after six weeks
Height (m)
Measured: 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.
Measured: At baseline and after six weeks
Plasma urea (g/L)
In all groups, by a spectrophotometric method using a commercial kit.
Measured: At baseline and after six weeks
Plasma creatinine (mg/L) levels
In all groups, by a spectrophotometric method using a commercial kit.
Measured: At baseline and after six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kasdi Merbah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadjer SAIFI, Hopital Mouhamed Boudiaf, Ouergla, Algeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860087
- Sponsor's protocol ID
- EA02/2025
- Acronym
- Cr and GDM
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Pregnant Women with Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06860087
- Acronym / sponsor ID
- Cr and GDM / EA02/2025
- Conditions
- Gestational Diabetes Mellitus (GDM), Oxidative Stress, Inflammatory Status, Insulin Resistance, Leptin Resistance, Glucose Metabolism Disorder
- Keywords
- Inflammatory status markers, Oxidative stress markers, Glucido-lipidic metabolism, HOMA-IR, Leptin level, Lipid profile, Fasting plasma glucose, Insulin level
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Kasdi MerbahUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| Women with gestational diabetes mellitus supplemented with 200 µg/day of chromium picolinate | Active comparator | 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. |
| Women with gestational diabetes mellitus supplemented with 400 µg/day of chromium picolinate | Active comparator | 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy pregnant women:
- Pregnant women with gestational diabetes mellitus:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | 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)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. | Dietary supplement | Women with gestational diabetes mellitus supplemented with 400 µg/day of chromium picolinate |
Primary outcome
Plasma chromium level (ng/dL)
Time frame: At baseline and after six weeks
In all groups by using Atomic Absorption Spectroscopy.
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.
Plasma cholesterol level (g/L)
Time frame: At baseline and after six weeks
In all groups, by spectrophotometric method using commercial kit.
Plasma triglyceride level (g/L)
Time frame: At baseline and after six weeks
In all groups, by spectrophotometric method using commercial kit.
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.
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.
Erythrocyte catalase (U/g Hb)
Time frame: At baseline and after six weeks
In all groups, by a spectrophotometric method using a commercial kit.
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.
Plasma 8-Hydroxydeoxyguanosine (ng/mL)
Time frame: At baseline and after six weeks
In all groups, by spectrophotometric method using commercial kit.
Erythrocye malondialdehyde (µm/L)
Time frame: At baseline and after six weeks
In all groups, by spectrophotometric method using commercial kit.
Erythrocyte carbonyl protein (µm/L)
Time frame: At baseline and after six weeks
In all groups, by spectrophotometric method using commercial kit.
Plasma tumor necrosis factor-α (pg/mL)
Time frame: At baseline and after six weeks
In all groups, by spectrophotometric method using commercial kit.
Plasma interleukin-10 (pg/mL)
Time frame: At baseline and after six weeks
In all groups, by spectrophotometric method using commercial kit.
Plasma insulin level (µU/mL)
Time frame: At baseline and after six weeks
In all groups, by immunological method using commercial kit.
7 secondary outcomes
Plasma leptin level (ng/mL)
Time frame: At baseline and after six weeks
Age (year)
Time frame: At baseline
Body Weight (kg)
Time frame: At baseline and after six weeks
Height (m)
Time frame: At baseline
Body Mass Index (kg/m^2)
Time frame: At baseline and after six weeks
Plasma urea (g/L)
Time frame: At baseline and after six weeks
Plasma creatinine (mg/L) levels
Time frame: At baseline and after six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d) and Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d) in people with Gestational Diabetes Mellitus (GDM) and Oxidative Stress, run by University of Kasdi Merbah at 1 site in Algeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadjer SAIFI, PhD in Biological Sciences (00213 660 210 813, saifi.hadjer@univ-ouargla.dz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma chromium level (ng/dL) (time frame: At baseline and after six weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.