Effect of symbiotic supplementation on lipid profile, glycemic control and hs-CRP

Phase 2

• Conditions: gestational diabetes mellitus.; Diabetes mellitus arising in pregnancy

• Registration Number: IRCT201511183140N16
• Lead Sponsor: utrition Research Center, Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Inclusion/exclusion 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 <18 years and over 40 years; Women with a history Multiple pregnancy or fetal malformations; Women in pregnancy week> 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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Dietary Factors. Timepoint: Baseline and after 6 weeks. Method of measurement: 3 day 24 hour food recall questionnaire.