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IRCT20180409039246N1 IRCT 2018-05-27 Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Effect of Beetroot Powder on diabetes treatment Investigation the Effect of Nitrate in Beetroot Powder (Beta Vulgaris) on Glycemic Control and Lipid Parameters in Type 2 Diabetic Patients 2018-05-05 anticipated 62 Complete https://irct.ir/trial/30456 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups, Blinding description: Given that the supplementation of Nitrate in the form of Beet Pulp in the supplement and the placebo is placed in the same full capsule, it is natural that the investigator and the patient are not aware of the type of supplement received. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group:250 mg nitrate supplement in beetroot powder. Intervention 2: Control group: free nitrate beetroot powder( nitrate below10 mg). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are no more information
public Zahra Bahadoran
No.24, Parveneh St., Yemen Blvd., Chamran Exp.
Tehran Iran (Islamic Republic of) 19395-4763 +98 22432500 zahrabahadoran@yahoo.com Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences scientific Zahra Bahadoran
No.24, Parveneh St., Yemen Blvd., Chamran Exp.
Tehran Iran (Islamic Republic of) 19395-4763 +98 21 2243 2500 zahrabahadoran@yahoo.com Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Non Pregnant and Non Breast Feeding Women 18 years 50 years Both Women of childbearing age without using a safe Contraceptive method Smokers and alcohol consumers Consumers of hormonal medicines Consumers of antioxidant supplements Subjects with Heart, Liver, Lung, Chronic Kidney Disease and Thyroid Disorders Subjects with acute or chronic Inflammatory Diseases Phosphodiesterase 5 inhibitors, Migraine drugs (such as Sumatriptan), Allopurinol, Tri-rings Antidepressants, Antihistamines, Nitrate-containing drugs, Meperidine, and Sedative Medicines Consumers E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Intervention group:250 mg nitrate supplement in beetroot powder Control group: free nitrate beetroot powder( nitrate below10 mg) Blood glucose. Timepoint: At baseline of study, 4, 12 and 24 week. Method of measurement: Enzymatic colorimetry. Hemoglobin glycosylated. Timepoint: At baseline of study, 4, 12 and 24 week. Method of measurement: Enzymatic method. Triglyceride. Timepoint: At baseline of study, 4, 12 and 24 week. Method of measurement: Enzymatic colorimetry. High density lipoprotein. Timepoint: At baseline of study, 4, 12 and 24 week. Method of measurement: Enzymatic colorimetry. Total cholesterol. Timepoint: At baseline of study, 4, 12 and 24 week. Method of measurement: Enzymatic colorimetry. Weight. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Scale. Physical activity. Timepoint: At baseline and end of study. Method of measurement: Physical activity questionnaire. Dietary intake. Timepoint: At baseline and end of study. Method of measurement: Feed Frequency Questionnaire. Blood pressure. Timepoint: At baseline and end of study. Method of measurement: Manometer. Concentration of Alanine Aminotransferase. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Photometry. Aspartate aminotransferase concentration. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Photometry. Concentration of alkaline phosphatase. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Photometry. Gamma glutamyltransferase concentration. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Photometry. Thyroid Stimulating Hormon. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Electrochemical Luminescence (Laboratory Kit). Total thyroxine. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Electrochemical Luminescence (Laboratory Kit). Free thyroxine. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Electrochemical Luminescence (Laboratory Kit). Free triiodothyronine. Timepoint: at baseline of study, 4th,12th and 24th week. Method of measurement: Electrochemical Luminescence (Laboratory Kit). Urinary microalbumin. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Immunoturbidometry. Urinary creatinine. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Jaffe kinetic method. Nitric Oxide Metabolites. Timepoint: at baseline of study, 4th,12th and 24th week. Method of measurement: Spectrophotometric method and Grease reaction. Waist circumference. Timepoint: At baseline of study, 4th,12th and 24th week. Method of measurement: Meter bar. Shahid Beheshti University of Medical Sciences Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Approved 2017-05-30 Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences No 24, Parvaneh st., Yemen Blvd., Chamran exp. Tehran Tehran Iran (Islamic Republic of)