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IRCT2016071127879N2 IRCT 2016-09-22 Bushehr University of Medical Sciences Effects of probiotics on lipid profile, glycemic index, oxidative stress and inflammatory markers in patients with diabetes type 2 Effects of probiotics on lipid profile, glycemic index, oxidative stress and inflammatory markers in patients with diabetes type 2; a clinical trial study 2016-08-22 anticipated 40 Complete https://irct.ir/trial/22748 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Type 2 Diabetes. Intervention 1: Intervention: patients in the treatment group received 1500 mg probiotic capsules twice daily (after lunch and dinner meals) for 6 weeks. The lactobacillus Probiotics contain: L. acidophilus 3.6 billion (×109 CFU) L. bulgaricus 600 million (×106 CFU) L. bifidum 600 million (×106 CFU) L. casei 1.2 billion (×109 CFU). Intervention 2: Control: Placebo Group receiving 1500 mg Magnesium Stearate capsules twice daily, for six weeks.
public Abbas Yousefinejad
Bushehr University of Medical Sciences, Bahmani St, Bushehr, Iran
Bushehr Iran (Islamic Republic of) +98 77 3345 0134 yousefinejad.abs@gmail.com Bushehr University of Medical Sciences scientific Abbas Yousefinejad
Bushehr University of Medical sciences, Bahmani St, Bushehr, Iran
Bushehr Iran (Islamic Republic of) +98 77 3345 0134 yousefinejad.abs@gmail.com Bushehr University of Medical sciences Iran (Islamic Republic of) Inclusion Criteria: Patients with diabetes type 2 are enrolled with FBS≥126 mgr/dl; less than 15 years of medical history; the age range is 25 to 65 years; the elective subjects, next drugs prescribed by physicians, should be controlled the status of glucose and lipid levels and during the study could use these drugs without changing in the prior dosage. Exclusion Criteria: Patients with diabetes type 2 that used alternative treatments like hormone therapy or supplemental vitamins; also those used tobacco and alcohol; patients with chronic kidney disease; liver, lung, chronic or acute inflammatory disease (especially acute pancreatic inflammation and Endocarditis); heart valve disease; short bowel syndrome; allergies; people with low immune system ability (autoimmune); pregnant or lactating women. 25 years 65 years Both E11 Non-insulin-dependent diabetes mellitus Treatment - Drugs Placebo Intervention: patients in the treatment group received 1500 mg probiotic capsules twice daily (after lunch and dinner meals) for 6 weeks. The lactobacillus Probiotics contain: L. acidophilus 3.6 billion (×109 CFU) L. bulgaricus 600 million (×106 CFU) L. bifidum 600 million (×106 CFU) L. casei 1.2 billion (×109 CFU) Control: Placebo Group receiving 1500 mg Magnesium Stearate capsules twice daily, for six weeks. Lipid Profile (Tg,Total Chol, LDL-C, HDL-C). Timepoint: Before and After Intervention. Method of measurement: Autoanalyzer. Serum Glucose. Timepoint: Before and after Intervention. Method of measurement: Autoanalyzer. Serum Insulin Levels. Timepoint: Before and After Intervention. Method of measurement: ELISA. Hs-CRP. Timepoint: Before and after intervention. Method of measurement: ELISA. IL-6. Timepoint: Before and After Intervention. Method of measurement: Autoanalyzer. Malodialdehyde (MDA). Timepoint: Before and after Intervention. Method of measurement: Specterophotometery. Bushehr University of Medical Sciences Approved 2016-07-18 Bushehr University of Medical Sciences Bushehr University of Medical Sciences Bushehr Iran (Islamic Republic of)