the effect of metformin on diastolic heart failure in diabetic patient with diastolic heart failure
Design
This is a double-blind, clinical interventional study. 114 patients with diabetes mellitus were enrolled in Amiralmomenin Hospital.
Settings and conduct
This is a double-blind, clinical interventional study. 114 patients with diabetes mellitus were enrolled in Amiralmomenin Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Not receiving metformin over the past 6 months, HbA1C less than 8/5, preserved EF or normal EF
Exclusion criteria: Intolerance to metformin, DKA , GFR less than 30 , systolic heart failure
Intervention groups
The first group of patients receiving metformin and the second group of patients who did not receive metformin. The first one received 500 milligram of metformin in the first week and we added 500 milligram to the patient's diet for a weekly period of two weeks. Daily dose of metformin for patients is 1500 milligram.
Main outcome variables
the effect of metformin on diastolic heart failure in diabetic patient with diastolic heart failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N69
Registration date:2018-02-20, 1396/12/01
Registration timing:registered_while_recruiting
Last update:2018-02-20, 1396/12/01
Update count:0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-29, 1396/08/07
Expected recruitment end date
2019-10-29, 1398/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of metformin on diastolic heart failure in diabetic patient with diastolic heart failure
Public title
Effect of metformin on diastolic heart failure in diabetic patient with diastolic heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not receiving metformin over the past 6 months
HbA1C less than 8/5
Preserved EFor normal EF
Exclusion criteria:
Intolerance to metformin
DKA
GFR less than 30
systolic heart failure
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Intervention group: The first group of patients receiving metformin .The first one received 500 milligram of metformin in the first week and we added 500 milligram to the patient's diet for a weekly period of two weeks. Daily dose of metformin for patients is 1500 milligram.
Category
Treatment - Drugs
2
Description
Control group: the second group of patients who did not receive metformin.