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Effect of oral Semaglutide vs Dapagliflozin on liver fat in patients with Type 2 Diabetes.

Effect of oral Semaglutide vs Dapagliflozin on hepatic steatosis in patients with Type 2 Diabetes mellitus and Metabolic dysfunction-associated steatotic liver disease – a pilot study - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076387
Enrollment
60
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: rybelsus: rybelsus 14 mg once a day orally for 6 months Control Intervention1: dapagliflozin: 10 mg once a day orally for 6 months

Sponsors

surbhi gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: both male and female are eligible Non pregnant patients with T2D above the age of 18 years with documented hepatic steatosis transient elastography CAP more than 275 db per m with the following criteria T2D patients with Hba1c more than 7 percent Ability and willingness to provide informed consent

Exclusion criteria

Exclusion criteria: age less than 18 years and more than 100 age Hba1c more than 10 percent Current treatment with GLP1RA Pioglitazone SGLT2i Saroglitazar History of congestive heart failure NYHA class 1 to 4 Irreversible medical conditions with predicted survival less than1 year Alcohol consumption more than 14 units per week for women and more than 21 units per week for men Severe hepatic impairment of any cause AST or ALT more than 5 times the upper limit of normal Evidence of other forms of liver disease including hepatitis B hepatitis C and autoimmune hepatitis History of use of drugs known to cause hepatic steatosis methotrexate amiodarone valproate steroids History of pancreatitis Family history of thyroid cancer Pregnant patients

Design outcomes

Primary

MeasureTime frame
To study and compare the effect of semaglutide and dapagliflozin over 6 months in reducing liver fat and fibrosis in patients with T2D and MASLD by using TE.Timepoint: 6 months

Secondary

MeasureTime frame
1. To study and compare the effect of semaglutide and dapagliflozin on changes in liver indices: FIB-4, FAST, AGILE 3+score. 2. To study and compare the effect of semaglutide and dapagliflozin on changes in laboratory parameters (transaminases, FPG, HbA1c, UACR, lipid profile). 3. To study and compare the effect of semaglutide and dapagliflozin on changes in Body Composition Analysis (BCA). Timepoint: 6 months;1. To study and compare the effect of semaglutide and dapagliflozin on changes in liver indices: FIB-4, FAST, AGILE 3+score. 2. To study and compare the effect of semaglutide and dapagliflozin on changes in laboratory parameters (transaminases, FPG, HbA1c, UACR, lipid profile). 3. To study and compare the effect of semaglutide and dapagliflozin on changes in Body Composition Analysis (BCA). Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Ambrish Mithal

max hospital saket

ambrishmithal@hotmail.com9811019093

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026