Effect of verapamil on GLP-1R in type 2 diabetic patients receiving metformin and sitagliptin
Design
Two arm parallel group randomised trial with blinded
Settings and conduct
A study on diabetes is performed in Ahwaz Golestan Hospital in a randomized, double blind clinical trial,
The study compares the effect of verapamil and placebo in two parallel groups of 23 patients
Participants/Inclusion and exclusion 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%
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)
Intervention groups
Intervention group:Verapamil effect on expression frequency of TXNIP, miR-204 and GLP-1 receptor
Control group:The effect of placebo on the above items
Main outcome variables
Frequency of expression of GLP-1R mRNA
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180417039339N1
Registration date:2018-08-07, 1397/05/16
Registration timing:prospective
Last update:2018-08-07, 1397/05/16
Update count:0
Registration date
2018-08-07, 1397/05/16
Registrant information
Name
farrokh ramesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8382
Email address
ramesh.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of verapamil on GLP-1R in type 2 diabetic patients receiving metformin and sitagliptin
Public title
Effect of verapamil on sitagliptin efficacy in diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
46
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
participants, principle investigator, data and safety monitoring board
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Jundishapur University of Medical Sciences
Street address
Esfand Ave, Farvardin Blvd, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.AJUMS.REC.1397.284
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Frequency of expression of GLP-1R mRNA
Timepoint
Before the intervention begins,Days 10,20,30 and 90
Method of measurement
Real-time PCR
2
Description
Frequency of expression of miR-204
Timepoint
Before the intervention begins,Days 10,20,30 and 90
Method of measurement
Real-time PCR
3
Description
Frequency of expression of TXNIP mRNA
Timepoint
Before the intervention begins,Days 10,20,30 and 90
Method of measurement
Real-time PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Verapamil 40mg , 3 times a day for 3 months
Category
Treatment - Drugs
2
Description
Control group: Placebo ,3 times a day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Farrokh Ramesh
Street address
Farvardin Blvd, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3001
Email
ramesh.f@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Esfand Ave, Farvardin Blvd, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61359-39937
Email
badavi/m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?