Effect of verapamil on sitagliptin efficacy in diabetes

Phase 3

Recruiting

Conditions: Diabetes mellitus.
Diabetes mellitus due to underlying condition

Registration Number: IRCT20180417039339N1

Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 46

Inclusion Criteria

Signature of consent by patients
Age between 20 and 65 years
Elapsed at least three months from detection of T2DM
Baseline A1c <8.5%

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures