Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Glycemic indexes, and liver and kidney functions
Glycemic indexes, liver and kidney functions, retinopathy and neuropathy complications, and pain score
Glycemic indexes, and liver and kidney functions, retinopathy and neuropathy complications, and pain score
شاخص های گلیسمیک، و عملکرد کبدی و کلیوی
شاخص های گلیسمیک، عملکرد کبدی و کلیوی، عوارض رتینوپاتی، عوارض نوروپاتی و نمره درد
شاخص های گلیسمیک، و عملکرد کبدی و کلیوی، عوارض رتینوپاتی، عوارض نوروپاتی و نمره درد
General information
2020-03-20, 1399/01/01
2021-06-22, 1400/04/01
20202021-0306-2022 00:00:00
2020-06-19, 1399/03/30
2021-10-22, 1400/07/30
20202021-0610-1922 00:00:00
empty
Adding a few other outcomes following the administration of empagliflozin
Adding a few other outcomes following the administration of empagliflozin
empty
افزودن چند پیامد دیگر به دنبال تجویز دارویempagliflozin
افزودن چند پیامد دیگر به دنبال تجویز دارویempagliflozin
The effects of empagliflozin on renal function in patients with type 2 diabetes in Bojnourd
The effects of empagliflozin on neuropathy and retinopathy outcomes as well as renal function in patients with type 2 diabetes in Bojnourd
The effects of empagliflozin on neuropathy and retinopathy outcomes as well as renal function in patients with type 2 diabetes in Bojnourd
بررسی اثرات دارویempagliflozin بر عملکرد کلیوی بیماران دیابتی نوع 2 شهرستان بجنورد
بررسی اثرات داروی empagliflozin بر پیامدهای نوروپاتی و رتینوپاتی و عملکرد کلیوی در بیماران دیابتی نوع 2 شهرستان بجنورد
بررسی اثرات دارویempagliflozinداروی empagliflozin بر پیامدهای نوروپاتی و رتینوپاتی و عملکرد کلیوی در بیماران دیابتی نوع 2 شهرستان بجنورد
Health conditions studied
#1
Evaluation of side effects and tolerability of impagliflozin in type 2 diabetic patients, evaluation of nephropathy and renal complication markers in patients with type 2 diabetes mellitus, patients' quality of life before and after use of impagliflozin.
Evaluation of side effects and tolerability of empagliflozin, Evaluation of neuropathy and retinopathy outcomes, Evaluation of nephropathy complications and indicators related to renal problems of empagliflozin in patients with type 2 diabetes, and Evaluation of quality of life of patients before and after taking empagliflozin.
Evaluation of side effects and tolerability of impagliflozin in type 2 diabetic patientsempagliflozin, evaluationEvaluation of neuropathy and retinopathy outcomes, Evaluation of nephropathy complications and indicators related to renal complication markersproblems of empagliflozin in patients with type 2 diabetes mellitus, patients'and Evaluation of quality of life of patients before and after use of impagliflozintaking empagliflozin.
بررسی عوارض جانبی و تحمل پذیری داروی امپاگلیفلوزین در افراد مبتلا به دیابت نوع 2، بررسی عوارض نفروپاتی و شاخص های مربوط به مشکلات کلیوی پس از مصرف داروی امپاگلیفلوزین در افراد مبتلا به دیابت نوع 2، بررسی کیفیت زندگی بیماران قبل و بعد از مصرف داروی امپاگلیفلوزین.
بررسی عوارض جانبی و تحمل پذیری امپاگلیفلوزین، بررسی پیامدهای نوروپاتی و رتینوپاتی، بررسی عوارض نفروپاتی و شاخص های مربوط به مشکلات کلیوی داروی امپاگلیفلوزین در افراد مبتلا به دیابت نوع 2، و بررسی کیفیت زندگی بیماران قبل و بعد از مصرف داروی امپاگلیفلوزین.
بررسی عوارض جانبی و تحمل پذیری داروی امپاگلیفلوزین در افراد مبتلا به دیابت نوع 2، بررسی پیامدهای نوروپاتی و رتینوپاتی، بررسی عوارض نفروپاتی و شاخص های مربوط به مشکلات کلیوی پس از مصرف داروی امپاگلیفلوزین در افراد مبتلا به دیابت نوع 2، و بررسی کیفیت زندگی بیماران قبل و بعد از مصرف داروی امپاگلیفلوزین.
Primary outcomes
#1
empty
Retinopathy studies
Retinopathy studies
empty
مطالعات رتینوپاتی
مطالعات رتینوپاتی
empty
Weeks 0 and 24
Weeks 0 and 24
empty
هفته های 0 و 24
هفته های 0 و 24
empty
Measurement of central macular thickness, corrected visual acuity, thickness of retinal and central subcutaneous tissue
Measurement of central macular thickness, corrected visual acuity, thickness of retinal and central subcutaneous tissue
empty
اندازه گیری ضخامت مرکزی ماکولا، حدت بینایی اصلاح شده، ضخامت بافت شبکیه و زیر شاخه مرکزی با استفاده از روش مقطع نگاری همدوسی اپتیکی
اندازه گیری ضخامت مرکزی ماکولا، حدت بینایی اصلاح شده، ضخامت بافت شبکیه و زیر شاخه مرکزی با استفاده از روش مقطع نگاری همدوسی اپتیکی
#2
empty
Neuropathy examinations
Neuropathy examinations
empty
معاینات نوروپاتی
معاینات نوروپاتی
empty
Weeks 0 and 24
Weeks 0 and 24
empty
هفته های 0 و 24
هفته های 0 و 24
empty
Pain score changes, EMG and NCV
Pain score changes, EMG and NCV
empty
تغییرات نمره درد، EMG و NCV
تغییرات نمره درد، EMG و NCV
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Kaveh Hojjat
Full name of responsible person - Persian: سید کاوه حجت
Street address - English: North Khorasan University of Medical Sciences, Dolat Blv., Bojnurd, North Khorasan
Street address - Persian: خراسان شمالی، بجنورد، بلوار دولت، ستاد مرکزی دانشگاه علوم پزشکی خراسان شمالی
City - English: Bojnurd
City - Persian: بجنورد
Province: North Khorasan
Country: Iran (Islamic Republic of)
Postal code: 74877-94149
Phone: +98 58 3229 7182
Fax:
Email: s.kavehhojjat1@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: َAmir Amani
Full name of responsible person - Persian: امیر امانی
Street address - English: North Khorasan University of Medical Sciences, Dolat Blv., Bojnurd, North Khorasan
Street address - Persian: خراسان شمالی، بجنورد، بلوار دولت، ستاد مرکزی دانشگاه علوم پزشکی خراسان شمالی
City - English: Bojnurd
City - Persian: بجنورد
Province: North Khorasan
Country: Iran (Islamic Republic of)
Postal code: 74877-94149
Phone: +98 58 3229 7182
Fax:
Email: amani76@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Kaveh HojjatَAmir Amani Full name of responsible person - Persian: سید کاوه حجتامیر امانی Street address - English: North Khorasan University of Medical Sciences, Dolat Blv., Bojnurd, North Khorasan Street address - Persian: خراسان شمالی، بجنورد، بلوار دولت، ستاد مرکزی دانشگاه علوم پزشکی خراسان شمالی City - English: Bojnurd City - Persian: بجنورد Province: North Khorasan Country: Iran (Islamic Republic of) Postal code: 74877-94149 Phone: +98 58 3229 7182 Fax: Email: s.kavehhojjat1amani76@gmail.com Web page address:
Protocol summary
Study aim
The effect of empagliflozin on renal function of type 2 diabetic patients
Design
This study is a randomized double blind clinical trial study. Patients in the study were randomly divided into two groups receiving empagliflozin at 10 mg daily (in the morning with water) or placebo (which was added to previous medications). Under special circumstances, the patient will receive emergency treatment. When the patient's hyperglycemia or hypoglycemia is uncontrollable, the patient is excluded. The allocation of patients to each of the study groups will be stratified randomly. According to the HbA1c index, patients are initially divided into two groups greater than 8.5 mg/dl and less than 8.5 mg/dl. Then, the required volume in each group is randomly assigned to each group. Randomization is done using a computer. The code of each intervention is kept confidential and given to the therapist by the clinic secretary to ensure the correct allocation is made randomly. The duration of treatment will be 24 weeks. At the beginning and end of the study, the target variables of the study will be examined. Patients will also be evaluated for side effects of the drug
Settings and conduct
The study population will be patients with type 2 diabetes referred to endocrinologist office in Bojnourd.
In this study, the therapist, patients, and the individual analyzing the results are blinded to the allocation of patints into two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetic patients known for at least 6 months
Exclusion criteria: eGFR less than 45, liver failure, type 1 diabetes, severe cardiovascular problems in the last three months, pregnancy and lactation.
Intervention groups
Case group: Empagliflozin recipient
Control group: placebo recipient
Main outcome variables
Glycemic indexes, liver and kidney functions, retinopathy and neuropathy complications, and pain score
General information
Reason for update
Adding a few other outcomes following the administration of empagliflozin
Acronym
IRCT registration information
IRCT registration number:IRCT20191126045505N1
Registration date:2020-01-06, 1398/10/16
Registration timing:prospective
Last update:2021-05-31, 1400/03/10
Update count:2
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Habibe Sadat Shakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 8118
Email address
drhssh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of empagliflozin on neuropathy and retinopathy outcomes as well as renal function in patients with type 2 diabetes in Bojnourd
Public title
Effects of empagliflozin in diabetes treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients who have been diagnosed for at least 6 months and treated at least with two anti-diabetic drugs.
7<HbA1c>10
BMI= Kg/m245
Exclusion criteria:
EGFR<45
Liver Failure
Type1 diabetes
History of ketosis
History of frequent falls and recurrent infections
Significant renal disease requiring dialysis
Inappropriate drug use
Serious medical conditions such as severe cardiovascular disease such as heart attack or stroke in the last three months
Blood pressure above 180/110 mmHg
Major surgery performed in the last 28 days
Cancer treatment in the past 5 years
Receiving systemic glucocorticoids
Alcohol or substance abuse
Pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
patients will be allocated to each group stratified randomly. According to the HbA1c index, patients are first divided into<5.8 and>5.8. Then, the required volume in each group (50 people) is randomly selected from the category.Randomization is done using a computer. For the purpose of the random assignment correctly, the code of any intervention is kept confidential by the secretary of the clinic regardless the patients' condition. Then, these envelopes are sealed and is giving to the specialist who will assign each patient to one of the intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and researchers (therapist) are not aware of the type of intervention for each patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee for Research of North Khorasan University of Medical Sciences
Street address
Central Building of North Khorasan University of Medical Sciences, Dolat Boulevard, Bojnourd
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Approval date
2019-11-03, 1398/08/12
Ethics committee reference number
IR.NKUMS.REC.1398.096
Health conditions studied
1
Description of health condition studied
Evaluation of side effects and tolerability of empagliflozin, Evaluation of neuropathy and retinopathy outcomes, Evaluation of nephropathy complications and indicators related to renal problems of empagliflozin in patients with type 2 diabetes, and Evaluation of quality of life of patients before and after taking empagliflozin.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of glycated hemoglobin or long-term blood sugar
Timepoint
Weeks 0 and 24
Method of measurement
Using the laboratory kit
2
Description
Fasting blood sugar measurement
Timepoint
Weeks 0 and 24
Method of measurement
Using the laboratory kit
3
Description
Measurement of glomerular filtration level for indirect evaluation of kidney status
Timepoint
weeks 0 and 24
Method of measurement
Using the laboratory kit
4
Description
Measurement of urine albumin concentration
Timepoint
weeks 0 and 24
Method of measurement
Using the laboratory kit
5
Description
Urine creatinine measurement
Timepoint
weeks 0 and 24
Method of measurement
Using the laboratory kit
6
Description
Measurement of changes in urinary albumin / creatinine ratio
Timepoint
weeks 0 and 24
Method of measurement
Using the laboratory kit
7
Description
Evaluation of aspartate aminotransferase level for evaluation of liver function
Timepoint
weeks 0 and 24
Method of measurement
Using the laboratory kit
8
Description
Evaluation of alanine aminotransferase level for evaluation of liver function
Timepoint
weeks 0 and 24
Method of measurement
Using the laboratory kit
9
Description
Measurement of blood alkaline phosphatase level for evaluation of hepatic function
Timepoint
weeks 0 and 24
Method of measurement
Using the laboratory kit
10
Description
Patient quality of life
Timepoint
Weeks 0 and 24
Method of measurement
Using questionnaire
11
Description
Retinopathy studies
Timepoint
Weeks 0 and 24
Method of measurement
Measurement of central macular thickness, corrected visual acuity, thickness of retinal and central subcutaneous tissue
12
Description
Neuropathy examinations
Timepoint
Weeks 0 and 24
Method of measurement
Pain score changes, EMG and NCV
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Placebo group
Category
Placebo
2
Description
Intervention group: received 10 mg empagliflozin daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinologist office in Bojnourd city
Full name of responsible person
Habibeh Sadat Shakeri
Street address
Research and Medical Center of Imam Hassan, North Khorasan, Pardis Town, Bojnourd, North Khorasan
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 0000
Email
drhssh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
َAmir Amani
Street address
North Khorasan University of Medical Sciences, Dolat Blv., Bojnurd, North Khorasan
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7182
Email
amani76@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Habibeh Sadat Shakeri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Educational, Research and Medical Center of Imam Hasan, Pardis town, Bojnurd, North khorasan
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 0000
Email
drhssh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Habibeh Sadat Shakeri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Educational, Research and Medical Center of Imam Hasan, Pardis town, Bojnurd, North Khorasan
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 0000
Email
drhssh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Habibeh Sadat Shakeri
Position
َAssociate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Educational, Research and Medical centr of Imam Hasan, Pardis town, Bojnurd, North Khorasan
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 0000
Email
drhssh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
At the end of the study and after the results are published, information about the study protocol, how to analyze the data, and the main outcomes are shared.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in academia and in the industries
Under which criteria data/document could be used
Any analysis and use of the data and documentation submitted will be conditional with informing project executor and her consent.
From where data/document is obtainable
Refer to Dr. Habieh Sadat Shakeri, principal Executor, for the documentation.
Email: drhssh@yahoo.com
Affiliations: Faculty of Medicine, Bojnourd University of Medical Sciences
What processes are involved for a request to access data/document
The applicant should send an application to Dr. Habieh Sadat Shaker by email and she will respond as soon as possible after reviewing and consulting with other project members.