Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117137
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-03
First Post:
2023-10-19
Brief Title:
The Impact Of SGLT2 -I on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
The Impact Of Sodium-Glucose Cotransporter 2 Inhibitors on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study question 1Could SGLT2-I improve hepatic fibrosis steatosis and inflammatory markers in type 2 diabetic patients with Metabolic associated steatotic liver disease Question 2Which drug of SGLT2-I group is more effective in improving metabolic associated steatotic liver disease in type 2 diabetic patients
Detailed Description:
patients will be derived from Endocrine or Hepatology outpatient clinic and who were primarily visiting for management of type 2 diabetes and other comorbidities
The effect of the SGLT2-I on metabolic associated steatotic liver disease patients with Type two diabetes mellitus will be a prospective open-label parallel-groups randomized clinical study to examine the effect of different types of SGLT2-I dapagliflozin empagliflozin when included in the standard treatment of Type two diabetes mellitus versus standard treatment without SGLT2-I for 24 weeks based on a predefined computer-generated number with a 11 allocation that will be concealed in patients with Type 2 diabetes mellitus and Metabolic associated steatotic liver disease Patients will be treated with combination therapy metformin andor sulfonylurea andor dipeptidyl peptidase 4 DPP-4 inhibitors andor insulin control group for whom treatment with SGLT2-I plus standard treatment for type 2 diabetes SGLT2-I group will be indicated due to poor diabetes control
- The patients will subsequently be classified and treated by the lines of diabetes therapy based on randomization into SGLT2-I or control group
Baseline assessment First visit
All patients before randomization will be subjected to
Detailed medical history including
Demographic characteristics Medications for glycemic control Compliance on medications Duration of Diabetes and presence of any comorbidity Diabetes complications
Detailed clinical examinations including
Height weight waist circumference Systolic blood pressure and diastolic blood pressure Body mass index BMI is calculated with division of weight in kg by square of height in meters
3 - Laboratory investigations Plasma glucose level Glycated hemoglobin HbA1c Blood urea and serum creatinine Serum uric acid Total bilirubin mgdL Alanine aminotransferase unitsL Aspartate aminotransferaseunitsL Albumin unitsL Total cholesterol LDL-cholesterol HDL-cholesterol Triglyceride Plasma non-HDL-cholesterol was simply calculated by following formula total cholesterol- HDL cholesterol
Uric acid to cholesterol ratio is calculated with division of serum uric acid by HDL cholesterol
The Uric acid to non-HDL cholesterol ratio is measured by the following formula uric acidnon-HDL cholesterol
Hepatitis B surface antigen anti-hepatitis C and HIV I and II antibodies Urine analysis and Albumin-to-creatinine ratio Complete blood counts Monocyte to high-density lipoprotein cholesterol ratio Neutrophil to lymphocyte ratio Platelet to lymphocyte ratio Lymphocyte to monocyte ratio Neutrophil-percentage-to-albumin ratio ECG 4-Other investigations will be including Abdominal ultrasonography Liver spleen size portal vein diameter 5- Non-Invasive Testing of Hepatic steatosisfibrosis Using vibration-controlled transient elastography FibroScan Study visits All participants will be instructed about potential adverse drug reactions Each participant will be asked to document all the symptoms that they will experience during the study period whether related to drug or not
Compliance and adverse events will be assessed by a verbal questionnaire In both groups adjustment of diabetes treatment will be carried out based on self-monitored blood glucose at weeks 4 and 8 by telephone consultation
All participants will be instructed to restrict simple carbohydrates avoid simple sugars reduce rice preparations and fat intake reduce butter ghee
All participants will be advised to exercise brisk walk for at least 45 min a day for at least 5 days a week
Participants will return to the outpatient hepatology clinic for follow-up visits at weeks 12 and 24
All the participants at baseline and at week 12 will receive uniform lifestyle modification instructions in accordance with the standards of diabetes management Anthropometry physical examination results and biochemical measurements will be recorded for each participant in week 24
Biochemical measurements at follow-up
Venous blood samples will be taken at week 24 in the morning after participants had fasted overnight for 12 h and the samples will be analyzed on the same day at the center laboratory of the hospital for the previous variables
Vibration controlled transient elastography VCTE parameters
Liver stiffness measurement LSM by VCTE related to liver fibrosis and controlled attenuation parameter CAP related to liver fat will be measured using Fibroscan a trained hepatologist who will be blinded to the drug allocation clinical data and biomarker data
Study group
At the end of the study all the patients will be classified according to Type of treatment Control group stander treatment of Type 2 diabetes mellitus without SGLT2-I SGLT2-I groups stander treatment of Type 2 diabetes mellitus plus SGLT2-I
SGLT2-I group will be sub-grouped to Group dapagliflozin stander treatment of Type 2 diabetes mellitus plus dapagliflozin Group empagliflozin stander treatment of Type 2 diabetes mellitus plus empagliflozin
The effect of the SGLT2-I on metabolic associated steatotic liver disease patients with Type two diabetes mellitus will be a prospective open-label parallel-groups randomized clinical study to examine the effect of different types of SGLT2-I dapagliflozin empagliflozin when included in the standard treatment of Type two diabetes mellitus versus standard treatment without SGLT2-I for 24 weeks based on a predefined computer-generated number with a 11 allocation that will be concealed in patients with Type 2 diabetes mellitus and Metabolic associated steatotic liver disease Patients will be treated with combination therapy metformin andor sulfonylurea andor dipeptidyl peptidase 4 DPP-4 inhibitors andor insulin control group for whom treatment with SGLT2-I plus standard treatment for type 2 diabetes SGLT2-I group will be indicated due to poor diabetes control
- The patients will subsequently be classified and treated by the lines of diabetes therapy based on randomization into SGLT2-I or control group
Baseline assessment First visit
All patients before randomization will be subjected to
Detailed medical history including
Demographic characteristics Medications for glycemic control Compliance on medications Duration of Diabetes and presence of any comorbidity Diabetes complications
Detailed clinical examinations including
Height weight waist circumference Systolic blood pressure and diastolic blood pressure Body mass index BMI is calculated with division of weight in kg by square of height in meters
3 - Laboratory investigations Plasma glucose level Glycated hemoglobin HbA1c Blood urea and serum creatinine Serum uric acid Total bilirubin mgdL Alanine aminotransferase unitsL Aspartate aminotransferaseunitsL Albumin unitsL Total cholesterol LDL-cholesterol HDL-cholesterol Triglyceride Plasma non-HDL-cholesterol was simply calculated by following formula total cholesterol- HDL cholesterol
Uric acid to cholesterol ratio is calculated with division of serum uric acid by HDL cholesterol
The Uric acid to non-HDL cholesterol ratio is measured by the following formula uric acidnon-HDL cholesterol
Hepatitis B surface antigen anti-hepatitis C and HIV I and II antibodies Urine analysis and Albumin-to-creatinine ratio Complete blood counts Monocyte to high-density lipoprotein cholesterol ratio Neutrophil to lymphocyte ratio Platelet to lymphocyte ratio Lymphocyte to monocyte ratio Neutrophil-percentage-to-albumin ratio ECG 4-Other investigations will be including Abdominal ultrasonography Liver spleen size portal vein diameter 5- Non-Invasive Testing of Hepatic steatosisfibrosis Using vibration-controlled transient elastography FibroScan Study visits All participants will be instructed about potential adverse drug reactions Each participant will be asked to document all the symptoms that they will experience during the study period whether related to drug or not
Compliance and adverse events will be assessed by a verbal questionnaire In both groups adjustment of diabetes treatment will be carried out based on self-monitored blood glucose at weeks 4 and 8 by telephone consultation
All participants will be instructed to restrict simple carbohydrates avoid simple sugars reduce rice preparations and fat intake reduce butter ghee
All participants will be advised to exercise brisk walk for at least 45 min a day for at least 5 days a week
Participants will return to the outpatient hepatology clinic for follow-up visits at weeks 12 and 24
All the participants at baseline and at week 12 will receive uniform lifestyle modification instructions in accordance with the standards of diabetes management Anthropometry physical examination results and biochemical measurements will be recorded for each participant in week 24
Biochemical measurements at follow-up
Venous blood samples will be taken at week 24 in the morning after participants had fasted overnight for 12 h and the samples will be analyzed on the same day at the center laboratory of the hospital for the previous variables
Vibration controlled transient elastography VCTE parameters
Liver stiffness measurement LSM by VCTE related to liver fibrosis and controlled attenuation parameter CAP related to liver fat will be measured using Fibroscan a trained hepatologist who will be blinded to the drug allocation clinical data and biomarker data
Study group
At the end of the study all the patients will be classified according to Type of treatment Control group stander treatment of Type 2 diabetes mellitus without SGLT2-I SGLT2-I groups stander treatment of Type 2 diabetes mellitus plus SGLT2-I
SGLT2-I group will be sub-grouped to Group dapagliflozin stander treatment of Type 2 diabetes mellitus plus dapagliflozin Group empagliflozin stander treatment of Type 2 diabetes mellitus plus empagliflozin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None