[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582190":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":23,"centralContacts":37,"locations":43,"responsibleParty":62,"collaborators":23,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":23,"maxAge":23,"enrollmentInfo":77,"targetDuration":23,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":93,"overallStatus":102,"whyStopped":23,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Kasdi Merbah","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Women with gestational diabetes mellitus supplemented with 200 µg\u002Fday 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.",[13],"Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg\u002Fd)",{"label":15,"type":10,"description":16,"interventionNames":17},"Women with gestational diabetes mellitus supplemented with 400 µg\u002Fday 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.",[18],"Dietary Supplement: Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg\u002Fd)",{"label":20,"type":21,"description":22,"interventionNames":23},"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.",null,{"label":25,"type":21,"description":26,"interventionNames":23},"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.",[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"DIETARY_SUPPLEMENT","Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg\u002Fd)","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.",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg\u002Fd)","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.",[15],[38],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},"Hadjer SAIFI, PhD in Biological Sciences","CONTACT","00213 660 210 813","saifi.hadjer@univ-ouargla.dz",[44],{"facility":45,"status":23,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Mohamed Boudiaf Hospital, Ouargla","Ouargla","Ouargla Province","30000","Algeria","DZ",{"type":52,"coordinates":53},"Point",[54,55],5.32502,31.94932,{"lat":55,"lon":54},[58],{"name":59,"role":40,"phone":60,"phoneExt":23,"email":61},"Nadira Benabdelkader, Doctorate in Medicine","00213 663 598 199","maya-mayar25@outlook.fr",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":66,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Hadjer SAIFI","Doctor of Biological Sciences, University Lecturer","Hopital Mouhamed Boudiaf, Ouergla, Algeria","100582190","phase-1-impact-of-chromium-supplementation-on-glucido-lipidic-metabolism-oxidative-stress-and-inflammatory-state-in-patients-with-gestational-diabetes-100582190",false,"NCT06860087","Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Patients with Gestational Diabetes","Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Pregnant Women with Gestational Diabetes Mellitus","Cr and GDM","Inclusion Criteria:\n\n* Healthy pregnant women:\n\n  * Whose their gestational age is 28 weeks\n  * They have no pathology or complication associated with their pregnancy.\n* Pregnant women with gestational diabetes mellitus:\n\n  * They will be selected according to the criteria of the one-step method for screening for gestational diabetes mellitus established by the WHO.\n  * They have no other pathology or complication associated with pregnancy.\n  * 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).\n* All women involved in this study will be systematically supplemented with 60 mg\u002Fd iron and 400 mg\u002Fd vitamin B9 during pregnancy as recommended by WHO.\n\nExclusion Criteria:\n\n* Pregnant women with unrecognized diabetes, type I or type II, will not be involved in this study.\n* 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.\n* Pregnant women who develop other health complications will be removed from the study and replaced by others.\n* 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.",true,"FEMALE",{"count":78,"type":79},200,"ESTIMATED","INTERVENTIONAL",[82,83],"PHASE1","PHASE2","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.\n\nThe main questions it aims to answer are:\n\n* Does chromium supplementation at various doses in women with gestational diabetes mellitus truly influence their glucido-lipidic metabolism, oxidative\u002Fantioxidant balance, and inflammatory state? If so, is it beneficial or detrimental?\n* If this supplementation is beneficial, which dose is the most appropriate?\n* 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).\n\nChromium-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.\n\nResearchers 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.\n\nResearchers will compare the effects of chromium supplements at different doses with each other.",[86,87,88,89,90,91,92],"Gestational Diabetes Mellitus (GDM)","Oxidative Stress","Inflammatory Status","Insulin Resistance","Leptin Resistance","Glucose Metabolism Disorder","Lipid Metabolism Disorders",[94,95,96,97,98,99,100,101],"Inflammatory status markers","Oxidative stress markers","Glucido-lipidic metabolism","HOMA-IR","Leptin level","Lipid profile","Fasting plasma glucose","Insulin level","NOT_YET_RECRUITING","2025-03-01",{"date":105,"type":106},"2025-03-05","ACTUAL",{"date":108,"type":79},"2025-05",{"date":110,"type":79},"2026-01",{"name":5,"class":6},1]