gestational diabetes mellitus. Diabetes mellitus arising in pregnancy
Conditions
Interventions
Intervention 1: Intervention Group:Women with Gestational Diabetes Mellitus receive 1 Lactofem Symbiotic Capsule one a day (After lunch), for 6 weeks. Each capsule contains 500 mg Symbiotic which prec
Treatment - Drugs
Placebo
Intervention Group:Women with Gestational Diabetes Mellitus receive 1 Lactofem Symbiotic Capsule one a day (After lunch), for 6 weeks. Each capsule contains 500 mg Symbiotic which precisely consist of
Placebo Group: Receiving 1 Placebo Capsules ones a day (after lunch), containing lactose, Colloidal silicon dioxide, Mg stearate, talc, Magnesium Stearate for 6 weeks
Sponsors
Nutrition Research Center, Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Inclusion/exclusion criteria : Inclusion criteria: All pregnant women diagnosed with gestational diabetes (women who began treatment with insulin.); The age range was 18 to 40 ; 28-24 weeks of pregnancy ; Singleton pregnancies; Lack of pre-eclampsia and eclampsia. Exclusion criteria: Pregnant women with a history of diabetes before pregnancy; Gestational hypertension (blood pressure equal to or greater than 140/90, without proteinuria is created at mid-pregnancy.); Age 28 ; People who show sensitivity to symbiotic or placebo capsules during the study; Those consume with less than 90% symbiotic or placebo capsules ; Tobacco and alcohol use; Pregnant women with a history of diseases affecting the metabolism of glucose, infection, chronic diseases, women consumers of antibiotics; Pregnant women with diseases such as immune deficiency, heart valve disease, syndrome Short bowel ischemia risk; If someone without pre-eclampsia and eclampsia recruited, but the poisoning was diagnosed during the study will be excluded
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IR. Timepoint: Baseline and after 6 weeks. Method of measurement: Formula.;Insulin Sensitivity. Timepoint: Baseline and after 6 weeks. Method of measurement: QUICKI Index.;Fasting Blood Sugar. Timepoint: Baseline and after 6 weeks. Method of measurement: Biochemical Analysis.;Serum Insulin. Timepoint: Baseline and after 6 weeks. Method of measurement: ELIZA.;Lipid profile: Total cholesterol, Triglyceride, HDL-C, LDL-C. Timepoint: Baseline and after 6 weeks. Method of measurement: Biochemical Analysis.;Hs-CRP. Timepoint: Baseline and after 6 weeks. Method of measurement: ELIZA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dietary Factors. Timepoint: Baseline and after 6 weeks. Method of measurement: 3 day 24 hour food recall questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZohoor Nabhani
Tabriz University of Medical Sciences, Faculty of Nutrition, Tabriz
Outcome results
None listed