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IRCT20130829014521N18 IRCT 2021-03-16 National Institute for Medical Research Development Trehalose and diabetes type 2 Investigation of the effects of oral trehalose supplementation on glycemic control in patients with type 2 diabetes 2021-06-22 anticipated 40 Complete https://irct.ir/trial/54391 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study has been designed as a randomized, triple-blind, placebo-controlled and parallel trial. Simple randomization for allocation and sealed envelope approach would be considered for concealed allocation, Blinding description: This study has been designed as triple-blind and persons including participants, care providers, investigators, and outcome assessors, keeping unaware of the treatment administered, moreover, drug and placebo vials have similar packaging and labeling. 2 Type 2 diabetes. Intervention 1: Intervention group: Terhalose (natural disaccharide), 1.65 g twice a day (3.3 g/day) for 3 months, in opaque sachet form. Intervention 2: Control group: Sucrose, 1.65 g twice a day (3.3 g/day) for 3 months, in opaque sachet form. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Amirhossein Sahebkar
School of Pharmacy, East door of Ferdowsi University, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 1882 9260 sahebkara@mums.ac.ir Mashhad University of Medical Sciences scientific Amirhossein Sahebkar
School of Pharmacy, East door of Ferdowsi University, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 1882 9260 sahebkara@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Male or female patients aged between 35 and 85 years Patients with non-insulin-dependent diabetes mellitus in a stable condition. 35 years 85 years Both Patients with type 1, type 2, or secondary diabetes receiving insulin therapy. Patients with renal dysfunction (eGFR less than 30 ml/min). Patients with severe liver dysfunction or cirrhosis. Patients regularly receiving oral or injectable corticosteroids. Patients who were pregnant or nursing or wished to conceive. Patients participating in this study will be excluded from the study if they need insulin. Patients who used α-Glucosidase Inhibitors such as acarbose will be excluded from the study. E11. 9 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Terhalose (natural disaccharide), 1.65 g twice a day (3.3 g/day) for 3 months, in opaque sachet form Control group: Sucrose, 1.65 g twice a day (3.3 g/day) for 3 months, in opaque sachet form HOMA-IR alterations. Timepoint: At the beginning and end of the intervention trial (Day 0 and week 12). Method of measurement: HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Fasting plasma glucose (FPG). Timepoint: Baseline and week 12. Method of measurement: Enzymatic assay. Fasting insulin. Timepoint: Baseline and week 12. Method of measurement: Immunoassay. HbA1c. Timepoint: Baseline and week 12. Method of measurement: chromatography. C peptide. Timepoint: Baseline and week 12. Method of measurement: Immunoassay. Hs-CRP. Timepoint: Baseline and week 12. Method of measurement: Turbidimetric. National Institute for Medical Research Development Approved 2020-11-18 Ethics committee of National institute for medical research development No. 21, west Fatemi Ave, Besat Ave, Tehran Tehran Tehran Iran (Islamic Republic of)