Fatty Liver, NonalcoholicNCT05041673
Anti-diabetic Drugs and Fatty Liver Management
A study testing Metformin in people with Fatty Liver, Nonalcoholic and Diabetes Mellitus, Type 2, run by Alexandria University at 1 site in Egypt.
Trial summary
Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver, Nonalcoholic, Diabetes Mellitus, Type 2
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Feb 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 DM with fatty liver disease.
- HbA1C less than 10.
Who cannot join
- Alcohol intake.
- BMI 40 or more.
- CKD with e GFR less than 60.
- chronic liver diseases (chronic viral hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alfa-1 antitrypsin deficiency)
- Atherosclerotic cardiovascular disease.
- Celiac disease.
- Clinically evident liver cirrhosis.
- Patients who have ever had medullary thyroid carcinoma (MTC) or who have a family member who has ever had and patients who have multiple endocrine neoplasia syndrome type 2 (MEN 2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Vildagliptin, Liraglutide and Empagliflozin in the Management of Fatty Liver Disease Among Patients With Type 2 Diabetes
Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease.
Study setting: Randomized controlled trial
Study population:
Patients with type 2 DM plus Fatty Liver.
Arms and Interventions
- Experimental arms: Group 1: metformin +/- insulin +/- sulfonylurea Group 2: Metformin plus vildagliptin+/- insulin +/- sulfonylurea Group 3: Metformin plus liraglutide+/- insulin+/- sulfonylurea Group 4: Metformin plus empagliflozin +/- insulin +/- sulfonylurea
Read the detailed description
Rational: Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease.
Study setting: Randomized controlled trial
Study population:
Patients with type 2 DM plus Fatty Liver.
NAFLD diagnostic criteria:
- Fatty Liver Index (FLI) 60 or more plus Ultrasound features of fatty liver.
- Inclusion criteria
- Age above 18. 2- HbA1C less than 10. Sample size: Based on the result reported by Armstrong et al, the proportion of patients on standard care who showed resolution of steatosis versus intervention group on liraglutide was 9% vs 39%, using power of 80%, precision of 5%, the minimal required sample size was 24 for each group and we increased it to 30 to compensate for drop-out. So, 120 subjects will be divided into 4 equal groups. Study Design: Interventional (Randomized Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking. Study duration: 12 months of follow up Data collection methods and tools <!-- -->
- Filling the pre-designed structured interview questionnaire from patients that includes:
- Demographic traits: age, sex, marital status, education, occupation and residency.
- Habits: smoking, physical exercise, dietary habits, drug use.
- Social history, focusing on smoking status, occupation, presence of children at home and plans for future pregnancy (as appropriate).
- Drug history
- Clinical data about:
- Present/ past/ family history on thyroid diseases, and autoimmune disease.
- Comorbidities: hypertension, coronary heart disease, chronic obstructive air way disease (COPD), obesity and others.
- Medications used: dose, frequency and route of administration.
- Hospitalization.
- Body measures: weight, height, body mass index (BMI), waist circumference.
- Vital signs: pulse, blood pressure, heart rate.
- The compliance was ascertained through direct questioning at each clinic visits and by inspecting her pill bottles.
- Patient satisfaction and quality of life will be measured at baseline and at the end of Intervention.
- Investigations
- Lab: HCV Ab, HBsAg, HBcAb, ALT, AST, GGT, FBS, HBA1c, PPBS, Fasting insulin, CBC, Cholesterol, LDL, HDL, TGs, uric acid.
- Calculation of the following score FLI, NAFLD-LFS, FIB-4, NFS.
- Imaging: ultrasound/FIBROSCAN/ MRI.
- Adverse effects of the drugs were systematically identified by careful health interview and clinical examinations. T-Bil, AST, ALT, and hematological values were measured for evaluation at every outpatient clinic visit. Follow-up All patients were followed up for twelve months:
- Dietary follow up.
- Liver enzymes (ALT, AST and GGT) at least every 3 months and more if clinically indicated
- Scores follow up: NFS and FIB-4 every 3 months.
- Fibroscan at end of 1-year follow up.
- MRI at end of 1-year follow up.
- Being tested
- Metformin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Liraglutide, empagliflozin, Vildagliptin
Antidiabetic drugs
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | metformin +/- insulin +/- sulfonylurea Receives: Drug: Metformin |
| Group 2 | Experimental | Metformin plus vildagliptin +/- insulin +/- sulfonylurea Receives: Drug: Metformin |
| Group 3 | Experimental | Metformin plus liraglutide +/- insulin+/- sulfonylurea Receives: Drug: Metformin |
| Group 4 | Experimental | Metformin plus empagliflozin +/- insulin +/- sulfonylurea Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in steatosis as measured using CAP score (fibroscan) and MRI
Measured: 12 months
Secondary outcomes (2)
Change in liver enzymes
Measured: 12 months
Changes in fibrosis grade
as measured by transient elastography (Fibroscan)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start23 Feb 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver, NonalcoholicStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Eva Pharma
- Responsible party
- Principal investigator, Ahmed Kamal, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041673
- Sponsor's protocol ID
- 0304932
- Status last verified
- Jan 2022
- First submitted
- 2 Sep 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vildagliptin, Liraglutide and Empagliflozin in the Management of Fatty Liver Disease Among Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05041673
- Acronym / sponsor ID
- 0304932
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Eva Pharma
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease.
Study setting: Randomized controlled trial
Study population:
Patients with type 2 DM plus Fatty Liver.
Arms and Interventions
- Experimental arms: Group 1: metformin +/- insulin +/- sulfonylurea Group 2: Metformin plus vildagliptin+/- insulin +/- sulfonylurea Group 3: Metformin plus liraglutide+/- insulin+/- sulfonylurea Group 4: Metformin plus empagliflozin +/- insulin +/- sulfonylurea
Detailed description
Rational: Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease.
Study setting: Randomized controlled trial
Study population:
Patients with type 2 DM plus Fatty Liver.
NAFLD diagnostic criteria:
- Fatty Liver Index (FLI) 60 or more plus Ultrasound features of fatty liver.
- Inclusion criteria
- Age above 18. 2- HbA1C less than 10. Sample size: Based on the result reported by Armstrong et al, the proportion of patients on standard care who showed resolution of steatosis versus intervention group on liraglutide was 9% vs 39%, using power of 80%, precision of 5%, the minimal required sample size was 24 for each group and we increased it to 30 to compensate for drop-out. So, 120 subjects will be divided into 4 equal groups. Study Design: Interventional (Randomized Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking. Study duration: 12 months of follow up Data collection methods and tools <!-- -->
- Filling the pre-designed structured interview questionnaire from patients that includes:
- Demographic traits: age, sex, marital status, education, occupation and residency.
- Habits: smoking, physical exercise, dietary habits, drug use.
- Social history, focusing on smoking status, occupation, presence of children at home and plans for future pregnancy (as appropriate).
- Drug history
- Clinical data about:
- Present/ past/ family history on thyroid diseases, and autoimmune disease.
- Comorbidities: hypertension, coronary heart disease, chronic obstructive air way disease (COPD), obesity and others.
- Medications used: dose, frequency and route of administration.
- Hospitalization.
- Body measures: weight, height, body mass index (BMI), waist circumference.
- Vital signs: pulse, blood pressure, heart rate.
- The compliance was ascertained through direct questioning at each clinic visits and by inspecting her pill bottles.
- Patient satisfaction and quality of life will be measured at baseline and at the end of Intervention.
- Investigations
- Lab: HCV Ab, HBsAg, HBcAb, ALT, AST, GGT, FBS, HBA1c, PPBS, Fasting insulin, CBC, Cholesterol, LDL, HDL, TGs, uric acid.
- Calculation of the following score FLI, NAFLD-LFS, FIB-4, NFS.
- Imaging: ultrasound/FIBROSCAN/ MRI.
- Adverse effects of the drugs were systematically identified by careful health interview and clinical examinations. T-Bil, AST, ALT, and hematological values were measured for evaluation at every outpatient clinic visit. Follow-up All patients were followed up for twelve months:
- Dietary follow up.
- Liver enzymes (ALT, AST and GGT) at least every 3 months and more if clinically indicated
- Scores follow up: NFS and FIB-4 every 3 months.
- Fibroscan at end of 1-year follow up.
- MRI at end of 1-year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Metforminmetformin +/- insulin +/- sulfonylurea |
| Group 2 | Experimental | Drug: MetforminMetformin plus vildagliptin +/- insulin +/- sulfonylurea |
| Group 3 | Experimental | Drug: MetforminMetformin plus liraglutide +/- insulin+/- sulfonylurea |
| Group 4 | Experimental | Drug: MetforminMetformin plus empagliflozin +/- insulin +/- sulfonylurea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 DM with fatty liver disease.
- HbA1C less than 10.
Key exclusion criteria (8 listed)
- Alcohol intake.
- BMI 40 or more.
- CKD with e GFR less than 60.
- chronic liver diseases (chronic viral hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alfa-1 antitrypsin deficiency)
- Atherosclerotic cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Liraglutide, empagliflozin, VildagliptinAntidiabetic drugs | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Change in steatosis as measured using CAP score (fibroscan) and MRI
Time frame: 12 months
2 secondary outcomes
Change in liver enzymes
Time frame: 12 months
Changes in fibrosis grade
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Fatty Liver, Nonalcoholic and Diabetes Mellitus, Type 2, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in steatosis as measured using CAP score (fibroscan) and MRI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.