Effect of Probiotics on diabetes mellitus arising in pregnancy
Phase 2
- Conditions
- Gestational Diabetes Mellitus.Diabetes mellitus arising in pregnancy
- Registration Number
- IRCT201405181597N3
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences and Health Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 64
Inclusion Criteria
nulliparity; diagnosis of gestational diabetes mellitus between 24 weeks and 0 days and 28 weeks and 6 days of pregnancy with oral screening test; fasting blood glucose level between 92- 126 mg/dl; body mass index 18.5 and more; nulliparity; negative history of f diabetes mellitus before the current pregnancy; chronic diseases; Smoking and/or alcohol consumption; probiotic food products consumption through current 2 weeks; antibiotic usage through current month; acute GI condition through current month and glucocorticoid and immunosuppressor drugs usage Exclusion criteria: need for insulin or other hypoglycemic drugs; corticosteroids or immune-suppressants usage or acute GI condition during the study
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting Blood Glucose. Timepoint: Before and after intervention. Method of measurement: Enzymatic.;Fasting Plasma Insulin. Timepoint: Before and after intervention. Method of measurement: Elisa.;Homeostatic Model Assessment/HOMA-IR. Timepoint: Before and after intervention. Method of measurement: Calculation.;Quantitative Insulin Sensitivity Check/QUICKI-index. Timepoint: Before and after intervention. Method of measurement: Calculation.
- Secondary Outcome Measures
Name Time Method