Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
Dapagliflozin, Hepatic steatosis, Sodium-glucose cotransporter 2 inhibitors, Body weight, Body mass index
Brief summary
This study was designed to assess the effect of dapagliflozin on body weight, blood sugar, liver enzymes, and blood fats in adults with non-alcoholic fatty liver disease (NAFLD), a condition involving excess fat accumulation in the liver. The study hypothesis was that changes in these measurements after 12 weeks would differ significantly between participants receiving dapagliflozin and those receiving placebo. The study was designed as a randomized, single-blind trial at the Department of Medicine, Shalamar Hospital, Lahore. Planned enrolment was 146 adults aged 20-70 years with NAFLD confirmed by ultrasound and a body mass index of at least 29 kg/m². Participants were to be randomly assigned to two equal groups of 73. One group was to receive dapagliflozin 10 mg by mouth once daily for 12 weeks, while the other was to receive an identical-looking placebo tablet containing no active medicine. Participants were to remain unaware of their assigned treatment. Both groups were to receive the same advice regarding diet, weight reduction, physical activity, and management of metabolic risk factors. The protocol specified measurements of body weight, body mass index, fasting blood sugar, HbA1c-a measure of average blood sugar-and liver enzymes before treatment and after 12 weeks. Blood fats, including cholesterol and triglycerides, and the ultrasound grade of liver fat were also included. Follow-up visits were scheduled every four weeks to assess medication use and record side effects. The planned analysis compared changes from baseline between the two treatment groups.
Interventions
Dapagliflozin tablet, 10 mg administered orally once daily for 12 weeks.
DRUGPlacebo
An identical-looking tablet containing no active drug, administered orally once daily for 12 weeks.
Sponsors
Shalamar Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 20-70 years * Diagnosed with NAFLD based on operational definition. * Body Mass Index (BMI) ≥ 29 kg/m²
Exclusion criteria
* Presence of other chronic liver diseases, including: Viral hepatitis (HBV or HCV), Autoimmune hepatitis, Wilson's disease, Hemochromatosis. * Use of medications known to cause hepatic steatosis (e.g., corticosteroids, methotrexate, tamoxifen) within the past 6 months as per history and medical records. * History of bariatric surgery as per medical records. * Active urinary tract infection based on urine analysis report. * Pregnancy or breastfeeding * Uncontrolled diabetes (HbA1c \> 9 %) * Severe cardiovascular disease * Renal impairment (eGFR \< 45 mL/min/1.73m²) * Active malignancy * Known hypersensitivity to dapagliflozin or any of its components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index | Baseline and 12 weeks | Mean change in body mass index, expressed in kg/m², compared between the dapagliflozin and placebo groups. Body mass index is calculated as weight in kilograms divided by height in metres squared. Weight is measured using a standardized digital weighing scale, and height is measured using a stadiometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline and 12 weeks | Mean change in body weight, expressed in kilograms, compared between the treatment groups. Weight is measured using a standardized digital weighing scale with participants wearing light clothing and no shoes. |
| Change in Fasting Blood Glucose | Baseline and 12 weeks | Mean change in fasting blood glucose, expressed in mg/dL, compared between the treatment groups. Glucose is measured using a standardized glucose meter after an overnight fast of at least eight hours. |
| Change in Glycated Hemoglobin | Baseline and 12 weeks | Mean change in glycated hemoglobin, expressed in percentage points, compared between the treatment groups. Glycated hemoglobin is measured using high-performance liquid chromatography. |
| Change in Serum Total Cholesterol | Baseline and 12 weeks | Mean change in serum total cholesterol, expressed in mg/dL, compared between the treatment groups. Serum levels are measured using an automated biochemical analyzer. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORHina Awan
Shalamar Hospital, Lahore
Outcome results
None listed