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The effect of Dapagliflozin on body composition in patients with type 2 Diabetes

Protocol summary

Study aim
Study of changes in blood sugar, lipid profile levels, body weight, fat mass, and muscle mass in diabetic subjects before and three months after starting dapagliflozin
Design
This is a single-group study involving patients with type 2 diabetes who will receive dapagliflozin daily for 3 months, without blinding or randomization. Phase 2 will be conducted on 37 diabetic patients, and body composition tests will be measured before and after the end of the drug treatment period.
Settings and conduct
In this study, patients with type 2 diabetes, without blinding and as directed by their physician after a blood test, will undergo a body composition test on two occasions, before and after three months of taking Dapagliflozin.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetic patients with blood sugar above 126 mg/dL. Exclusion criteria: Patients unable to perform body analysis tests, including surgery or pregnancy.
Intervention groups
Diabetic patients receiving Dapagliflozin (5 mg daily) for three months
Main outcome variables
Dapagliflozin, age, body weight, sex, fasting blood sugar, hemoglobin A1c Lipid profile including: cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides Fat mass, muscle mass, total body water, body mass index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251108067913N2
Registration date: 2026-07-13, 1405/04/22
Registration timing: prospective

Last update: 2026-07-13, 1405/04/22
Update count: 0
Registration date
2026-07-13, 1405/04/22
Registrant information
Name
Vahid Radmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3477
Email address
radmehr.v@ajums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2027-08-23, 1406/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Dapagliflozin on body composition in patients with type 2 Diabetes
Public title
Studying the effect of Dapagliflozin in Diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients who will start taking dapagliflozin
Exclusion criteria:
Diabetic patients who have undergone surgery and are not able to perform a body composition test Female patients who are pregnant Taking medications related to weight loss Having other diseases, such as cancer
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 37
More than 1 sample in each individual
Number of samples in each individual: 2
Performing a physical analysis and other blood factors test before starting and three months after taking dapagliflozin
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is designed as a before-and-after clinical trial study in which the studied factors will be measured in one group at two times, before and three months after starting dapagliflozin.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, North Esfand St, Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2025-08-12, 1404/05/21
Ethics committee reference number
IR.AJUMS.REC.1404.539

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications

Primary outcomes

1

Description
Fasting blood glucose
Timepoint
Before the start of the intervention and three months after the start of the intervention
Method of measurement
Auto analyzer device

2

Description
Glycosylated hemoglobin A1c
Timepoint
Before the start of the intervention and three months after the start of the intervention
Method of measurement
Auto analyzer device

3

Description
Body fat mass
Timepoint
Before the start of the intervention and three months after the start of the intervention
Method of measurement
Body analysis device

4

Description
Total body muscle mass
Timepoint
Before the start of the intervention and three months after the start of the intervention
Method of measurement
Body analysis device

5

Description
Total body water
Timepoint
Before the start of the intervention and three months after the start of the intervention
Method of measurement
Body analysis device

Secondary outcomes

1

Description
Low-density lipoprotein
Timepoint
Before the start of the intervention and three months after the start of the intervention
Method of measurement
Auto analyser device

2

Description
High-density lipoprotein
Timepoint
Before the start of the intervention and three months after the start of the intervention
Method of measurement
Auto analyser device

3

Description
Triglyceride
Timepoint
Before the start of the intervention and three months after the start of the intervention
Method of measurement
Auto analyser device

4

Description
Cholestrol
Timepoint
Before the start of the intervention and three months after the start of the intervention
Method of measurement
Auto analyser device

Intervention groups

1

Description
Intervention group: Diabetic patients will receive dapagliflozin (C21H25Cl1O6), Kimia Pharmaceutical Company (Foxibet), a sodium-glucose cotransporter inhibitor in the renal proximal tubule, 5 mg daily after breakfast for three months. In these patients, the desired factors will be measured once before starting dapagliflozin and three months after the start of the intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Vahid Radmehr
Street address
Mofid St, Farvardin Blvd, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-33117
Phone
+98 61 3320 4501
Email
vahid.radmehr2@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdollah Rafiei
Street address
North esfand St, Farvardin Blvd, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8383
Email
rafiei-a@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Vahid Radmehr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
North esfand St, Farvardin Blvd, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
vahid.radmehr2@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vahid Radmehr
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
North esfand St, Farvardin Blvd, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8383
Email
vahid.radmehr2@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vahid Radmehr
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
North Esfand St, Farvardin Blvd, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8383
Email
vahid.radmehr2@gmail.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Analytic Code
Not applicable
Data Dictionary
Not applicable
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