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IRCT20180417039339N1 IRCT 2018-08-07 Ahvaz University of Medical Sciences Effect of verapamil on sitagliptin efficacy in diabetes Effect of verapamil on GLP-1R in type 2 diabetic patients receiving metformin and sitagliptin 2018-08-23 anticipated 46 Complete https://irct.ir/trial/32331 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization: block Unit of randomization : individual Randomization strata in stratified randomization:HbA1C , BMI Tools used in randomization : sealed envelops How the random sequence was built: table of random numbers Whether of not allocation concealment was carried out:Sealed envelopes will be opaque, Blinding description: participants, principle investigator, data and safety monitoring board. 3 Diabetes mellitus. Intervention 1: Intervention group: Verapamil 40mg , 3 times a day for 3 months. Intervention 2: Control group: Placebo ,3 times a day for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Farrokh Ramesh
Jundishapur University, Esfand Ave, Farvardin Blvd, Golestan, Ahvaz
Ahvaz Iran (Islamic Republic of) 61359-39937 +98 61 3373 8382 ramesh.f@ajums.ac.ir Ahvaz University of Medical Sciences scientific Farrokh Ramesh
Jundishapur University, Esfand Ave, Farvardin Blvd, Golestan, Ahvaz
Ahvaz Iran (Islamic Republic of) 61359-39937 +98 61 3373 8382 ramesh.f@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Signature of consent by patients Age between 20 and 65 years Elapsed at least three months from detection of T2DM Baseline A1c <8.5% 20 years 65 years Both Pregnancy and lactation Uncompensated heart failure myocardial infarction or evidence of ischemic heart disease or other serious cardiac disease within the 12 weeks before randomization History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, peripheral vascular disease or cerebrovascular disease known left ventricular dysfunction hypotension (systolic pressure <90 mm Hg) PR interval prolongation on EKG or any bradyarrhythmia (e.g. sick sinus syndrome, AV block) Wolff-Parkinson- White [WPW] syndrome Lown-Ganong-Levine syndrome Concomitant use of drugs that affect blood glucose levels Untreated hypothyroidism or active Graves' disease with hyperthyroidism Serum creatinine >1.5 mg/dl ,GFR<60 Currently receiving insulin therapy Total bilirubin , Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 x ULN Hypersensitivity to verapamil or any component of the formulation E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Intervention group: Verapamil 40mg , 3 times a day for 3 months Control group: Placebo ,3 times a day for 3 months Frequency of expression of GLP-1R mRNA. Timepoint: Before the intervention begins,Days 10,20,30 and 90. Method of measurement: Real-time PCR. Frequency of expression of miR-204. Timepoint: Before the intervention begins,Days 10,20,30 and 90. Method of measurement: Real-time PCR. Frequency of expression of TXNIP mRNA. Timepoint: Before the intervention begins,Days 10,20,30 and 90. Method of measurement: Real-time PCR. Ahvaz University of Medical Sciences Approved 2018-07-02 The Ethics Committee of the Jundishapur University of Medical Sciences Esfand Ave, Farvardin Blvd, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)