Determining the effect of empagliflozin on thyroid function tests
Design
Clinical trial without control group، without parallel group، non-randomized on 44 patients
Settings and conduct
All patients aged 18-65 who referred to Besat Clinic in Kerman with prediabet or type 2 diabetes who were newly diagnosed but are not being treated with any medication to control diabetes. All patients will go to a single laboratory for sampling at 8-10 in the morning and after filling the informed consent form، sampling will be done by an expert from the partner workshop of the plan for TSH، TT3، TT4، FT4، BUN، CR، FBS، HBA1c، TG، CHOL، LDL، HDL are done. Patients must be fasting for 12 hours before sampling، and blood pressure، height and weight of the patient will also be measured and recorded by the project partner.
Patients are treated with empagliflozin 10 mg daily for three months, and at the end of the third month, TSH، TT3، TT4، FT4، TG، CHOL، LDL، HDL، BUN، CR، HBA1c، FBS tests in the same primary laboratory.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Having diabetes mellitus 2 or prediabet
2- The level of HBA1c is at most 0.5-1% more than the target set for the patient
3- Not receiving medication to control blood sugar
Exit criteria:
1- Suffering from type 1 diabetes
2- Suffering from thyroid dysfunction (hypothyroidism، hyperthyroidism)
3- Use of methimazole or levothyroxine
4- Use of insulin or diabetes control drugs
5- GFR<30
6- History of diabetic ketoacidosis or any underlying disease that predisposes a person to acidosis.
7- Liver failure
8-Patients who are treated with other drugs affecting the metabolism of thyroid hormones
Intervention groups
Administration of empagliflozin to prediabets and type 2 diabetes patients with normal thyroid function
Main outcome variables
TSH ،T3، free T4،total T4 after 3 months of empagliflozin consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090317001774N10
Registration date:2023-02-23, 1401/12/04
Registration timing:prospective
Last update:2023-02-23, 1401/12/04
Update count:0
Registration date
2023-02-23, 1401/12/04
Registrant information
Name
Mojgan Sanjari
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2506
Email address
msanjari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-25, 1402/01/05
Expected recruitment end date
2023-04-25, 1402/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of empaglifluzine on the serum level of thyroid functional tests in prediabets and new-diagnosed diabetis
Public title
Empaglifluzin effect on thyroid function tests
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes type 2 or prediabet
The level of HBA1c، 0.5-1% more than the target set for the patient
Not receiving medication to control diabetes
Exclusion criteria:
Diabetes type 1
Hypo or hyperthyroidism
Consumption of levothyroxine or methimazole
Use of insulin or diabetes control drugs (biguanides، sulfonylureas، thiazolideones، SGLT2- inhibitors، GLP-1 receptor agonists، bromocriptine، cholestyramine، Dapaglifluzin
GFR<30
A history of diabetic ketoacidosis or any underlying disease that predisposes a person to acidosis.
History of liver failure
Patients who are treated with other drugs affecting the metabolism of thyroid hormones (Amiodarone، Lithium، Androgen، Estrogen)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Kerman University of Medical Sciences
Street address
Imam Khomeini Highway
City
kerman
Province
Kerman
Postal code
7616913355
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.KMU.AH.REC.1401.224
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Serum thyroid stimulating hormone level
Timepoint
Before starting the study and after three months taking of empagliflozin
Method of measurement
Blood sampling
Secondary outcomes
1
Description
Serum T4 level
Timepoint
Before starting the study and after three months taking of empagliflozin
Method of measurement
Blood sampling
Intervention groups
1
Description
Intervention group: patients with prediabetes and type 2 diabetes under treatment for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Clinic
Full name of responsible person
Dr. Mojgan Sanjari
Street address
Somayeh Crossroads (Tahmasebabad)
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 8740
Email
msanjari@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza MalekpourAfshar
Street address
Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
malekpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mojgan Sanjari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology
Street address
Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 1322 2506
Fax
+98 34 1211 3426
Email
msanjari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mojgan Sanjari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Edocrinology
Street address
Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 1322 2506
Fax
+98 34 1211 3426
Email
msanjari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mojgan Sanjari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 1322 2506
Fax
+98 34 1211 3426
Email
msanjari@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available