Diabetes Mellitus, Type 1Phase 3NCT06348706
Effect of Dipeptidyl Peptidase- 4 Inhibitors on Non-Alcoholic Steatohepatitis and Type 1 Diabetes
A Phase 3 study testing Dipeptidyl peptidase 4 (DPP-4) inhibitor in people with Diabetes Mellitus, Type 1 and NASH, run by Ain Shams University at 1 site in Egypt.
Trial summary
Background: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that can precipitate to advanced fibrosis and leads to cardiovascular morbidity and mortality. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, NASH
- What is being tested?
- Dipeptidyl peptidase 4 (DPP-4) inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2022to 15 Jan 2024
- Phase
- Phase 3
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents diagnosed with type 1 diabetes according to ISPAD guidelines .
- Patients aged 12-18 years with NASH.
- Patients on regular visit to clinic.
- Patients on regular insulin therapy.
Who cannot join
- Patients with renal impairment due to cause other than diabetes.
- Patients with hypertension.
- Hyper- or hypo-thyroidism.
- Hepatitis virus infection (B or C) or any evidence of infection.
- History of liver disease other than NASH such as cholestasis and Wilson disease.
- Patients with autoimmune hepatitis.
Show all 10Show fewer
- Recurrent diabetic ketoacidosis (more than 2 episodes in the previous 12 months)
- Patients were already on anti-hypertensive drugs or any antioxidant therapy such as vitamin supplements.
- Taking any vitamins or food supplements one month before study.
- Participation in a previous investigational drug study within 3 months preceding screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dipeptidyl Peptidase- 4 Inhibitors Supplementation on Non-Alcoholic Steatohepatitis in Adolescents With Type 1 Diabetes Mellitus
Background: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that can precipitate to advanced fibrosis and leads to cardiovascular morbidity and mortality. Many patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and met the histological criteria for NASH. Matrix metalloproteinase-14 (MMP-14) is a type 1 transmembrane proteinase expressed in liver fibrosis and is involved in the development of atherosclerosis and cardiovascular disease. Hepatic dipeptidyl peptidase-4 (DPP-4) expression in NAFLD may be directly associated with hepatic lipogenesis and liver injury. Some studies showed the beneficial effect of dipeptidyl peptidase-4 (DDP-4) inhibitors in NAFLD/NASH for their role in improving hepatic glucose metabolism. Vildagliptin, a DPP-4 inhibitor, could be promising therapeutic agents for NAFLD/NASH.
To the best of our knowledge, no previous study assessed the role of DPP-4 inhibitors in adolescent patients with T1DM and NASH.
Read more
Objectives: This randomized-controlled clinical trial assessed the impact of the oral DPP-4 inhibitor, vildagliptin, as an add-on therapy on NASH in adolescents with T1DM as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis.
Methods: This study included 60 adolescents with T1DM and NASH with a mean age 15.6 ± 2.08 years and disease duration ≥ 5 years. Forty age- and sex-matched healthy subjects with a mean age 14.9 ± 3.2 years were enrolled as healthy controls to compare MMP-14 levels. T1DM patients were randomly assigned to receive oral vildagliptin (50 mg daily) with lunch meal for six months or not. Fasting and 2 hours post-prandial blood glucose levels, HbA1c, liver function tests, fasting lipid profile, hepatic steatosis index and triglyceride glucose (TyG) index were assessed. MMP-14 levels were measured by enzyme-linked immunosorbent assay among all patients and healthy controls. CIMT was assessed using Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) was performed to assess liver stiffness and steatosis stage.
Read the detailed description
Non-Alcoholic Fatty Liver Disease (NAFLD) is characterised by excessive hepatic fat accumulation (steatosis) in the absence of significant alcohol consumption, occurring with or without hepatic inflammation and fibrosis. Steatosis may progress to a more advanced form of the disease, non-alcoholic steatohepatitis (NASH), which can precipitate to advanced fibrosis, leading to cirrhosis and/or hepatocellular carcinoma (HCC) and can result in the need for liver transplantation or death as well as cardiovascular morbidity and mortality.
It was demonstrated that 53.1% of patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and 20.4% met the histological criteria for NASH. Patients with T1DM onset at an earlier age have an increased incidence of cardiovascular disease (CVD) events and increased CVD mortality.
Matrix metalloproteinases (MMPs) are found to have multiple biological activities including diseases like angiogenesis and cirrhosis. They are expressed in atherosclerotic plaques, promoting vascular remodelling, contributing to atherothrombosis, and plaque disruption. MMP-14 is involved in the development of atherosclerosis and CVD. MMP-14 is also noticed to be expressed in highly invasive hepatocellular carcinoma and expressed in liver fibrosis.
Carotid ultrasound is easily available, a cost effective and non-invasive tool for evaluating carotid artery intima-media thickness (CIMT) to assess CVD as carotid atherosclerosis. CIMT was higher for individuals with NASH than for those with simple steatosis.
Dipeptidyl peptidase-4 (DPP-4) inhibitors are a relatively new class of oral diabetes drugs with a glucose-lowering effect. DPP-4 inhibitors exert their glucose-lowering effects primarily by blocking the enzyme DPP-4, which is involved in the degradation of incretins, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). DPP-4 inhibitors are widely used for the treatment of type 2 diabetes since 2006. Although DPP-4 inhibitors may be beneficial for T1DM, existing studies do not strongly support these positive effects in clinical practice.
Vildagliptin, an oral antihyperglycemic agent that competitively inhibits DPP-4. A few trials have demonstrated that vildagliptin has an effect on NAFLD. In 44 patients with T2DM and hepatic steatosis, vildagliptin treatment for 6 months decreased liver enzymes and intrahepatic triglyceride content, as assessed by MRI. In a study conducted in Pakistan, vildagliptin for 12 weeks improved liver enzymes and steatosis grading, as assessed by ultrasound.
Aim: To assess the effect of Dipeptidyl peptidase-4 (DPP-4) inhibitors supplementation as an add on therapy on NASH in adolescents with type 1 diabetes mellitus as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis.
- Conditions
- Diabetes Mellitus, Type 1, NASH
- Being tested
- Dipeptidyl peptidase 4 (DPP-4) inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipeptidyl peptidase 4 (DPP-4) inhibitorDrug
Also called Dipeptidyl peptidase-4 inhibitors
Intervention group received Dipeptidyl peptidase-4 (DPP-4) inhibitors supplementation in a dose of 50 mg with main meal for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Dipeptidyl peptidase-4 inhibitors supplementation | Active comparator | Intervention group receiving Dipeptidyl peptidase-4 inhibitors supplementation Receives: Drug: Dipeptidyl peptidase 4 (DPP-4) inhibitor |
| Control group | No intervention | Control group not receiving Dipeptidyl peptidase-4 inhibitors supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related effect on NASH status in adolescents with type 1 diabetes mellitus
Effect of DPP-4 inhibitors on NASH in adolescents with type 1 diabetes mellitus measured by Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) to assess liver stiffness and steatosis stage.
Measured: 6 months
Secondary outcomes (2)
Number of participants with treatment-related Matrix metalloproteinase-14 (MMP-14) level change
Effect of (DPP-4) inhibitors supplementation on Matrix metalloproteinase-14 (MMP-14, (ng/mL) level
Measured: 6 months
Number of participants with treatment-related Glycemic control (HbA1c%) level change
Effect of Dipeptidyl peptidase-4 (DPP-4) inhibitors on glycemic control (HbA1c%)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start10 Nov 2022
- Primary completion1 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Samir Elbarbary, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348706
- Sponsor's protocol ID
- Ain Shams University25032024
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Temple JL, Cordero P, Li J, Nguyen V, Oben JA. A Guide to Non-Alcoholic Fatty Liver Disease in Childhood and Adolescence. Int J Mol Sci. 2016 Jun 15;17(6):947. doi: 10.3390/ijms17060947.
PubMed 27314342Verges B. Cardiovascular disease in type 1 diabetes: A review of epidemiological data and underlying mechanisms. Diabetes Metab. 2020 Nov;46(6):442-449. doi: 10.1016/j.diabet.2020.09.001. Epub 2020 Sep 28.
PubMed 32998054Geervliet E, Moreno S, Baiamonte L, Booijink R, Boye S, Wang P, Voit B, Lederer A, Appelhans D, Bansal R. Matrix metalloproteinase-1 decorated polymersomes, a surface-active extracellular matrix therapeutic, potentiates collagen degradation and attenuates early liver fibrosis. J Control Release. 2021 Apr 10;332:594-607. doi: 10.1016/j.jconrel.2021.03.016. Epub 2021 Mar 15.
PubMed 33737203Targher G, Bertolini L, Padovani R, Rodella S, Zoppini G, Zenari L, Cigolini M, Falezza G, Arcaro G. Relations between carotid artery wall thickness and liver histology in subjects with nonalcoholic fatty liver disease. Diabetes Care. 2006 Jun;29(6):1325-30. doi: 10.2337/dc06-0135.
PubMed 16732016Sumida Y, Yoneda M, Tokushige K, Kawanaka M, Fujii H, Yoneda M, Imajo K, Takahashi H, Eguchi Y, Ono M, Nozaki Y, Hyogo H, Koseki M, Yoshida Y, Kawaguchi T, Kamada Y, Okanoue T, Nakajima A, Jsg-Nafld JSGON. Antidiabetic Therapy in the Treatment of Nonalcoholic Steatohepatitis. Int J Mol Sci. 2020 Mar 11;21(6):1907. doi: 10.3390/ijms21061907.
PubMed 32168769Wang Q, Long M, Qu H, Shen R, Zhang R, Xu J, Xiong X, Wang H, Zheng H. DPP-4 Inhibitors as Treatments for Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis. J Diabetes Res. 2018 Jan 8;2018:5308582. doi: 10.1155/2018/5308582. eCollection 2018.
PubMed 29507862Hussain M, Majeed Babar MZ, Hussain MS, Akhtar L. Vildagliptin ameliorates biochemical, metabolic and fatty changes associated with non alcoholic fatty liver disease. Pak J Med Sci. 2016 Nov-Dec;32(6):1396-1401. doi: 10.12669/pjms.326.11133.
PubMed 28083033
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dipeptidyl Peptidase- 4 Inhibitors Supplementation on Non-Alcoholic Steatohepatitis in Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06348706
- Acronym / sponsor ID
- Ain Shams University25032024
- Conditions
- Diabetes Mellitus, Type 1, NASH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 5 Apr 2024 (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.
Background: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that can precipitate to advanced fibrosis and leads to cardiovascular morbidity and mortality. Many patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and met the histological criteria for NASH. Matrix metalloproteinase-14 (MMP-14) is a type 1 transmembrane proteinase expressed in liver fibrosis and is involved in the development of atherosclerosis and cardiovascular disease. Hepatic dipeptidyl peptidase-4 (DPP-4) expression in NAFLD may be directly associated with hepatic lipogenesis and liver injury. Some studies showed the beneficial effect of dipeptidyl peptidase-4 (DDP-4) inhibitors in NAFLD/NASH for their role in improving hepatic glucose metabolism. Vildagliptin, a DPP-4 inhibitor, could be promising therapeutic agents for NAFLD/NASH.
To the best of our knowledge, no previous study assessed the role of DPP-4 inhibitors in adolescent patients with T1DM and NASH.
Objectives: This randomized-controlled clinical trial assessed the impact of the oral DPP-4 inhibitor, vildagliptin, as an add-on therapy on NASH in adolescents with T1DM as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis.
Methods: This study included 60 adolescents with T1DM and NASH with a mean age 15.6 ± 2.08 years and disease duration ≥ 5 years. Forty age- and sex-matched healthy subjects with a mean age 14.9 ± 3.2 years were enrolled as healthy controls to compare MMP-14 levels. T1DM patients were randomly assigned to receive oral vildagliptin (50 mg daily) with lunch meal for six months or not. Fasting and 2 hours post-prandial blood glucose levels, HbA1c, liver function tests, fasting lipid profile, hepatic steatosis index and triglyceride glucose (TyG) index were assessed. MMP-14 levels were measured by enzyme-linked immunosorbent assay among all patients and healthy controls. CIMT was assessed using Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) was performed to assess liver stiffness and steatosis stage.
Detailed description
Non-Alcoholic Fatty Liver Disease (NAFLD) is characterised by excessive hepatic fat accumulation (steatosis) in the absence of significant alcohol consumption, occurring with or without hepatic inflammation and fibrosis. Steatosis may progress to a more advanced form of the disease, non-alcoholic steatohepatitis (NASH), which can precipitate to advanced fibrosis, leading to cirrhosis and/or hepatocellular carcinoma (HCC) and can result in the need for liver transplantation or death as well as cardiovascular morbidity and mortality.
It was demonstrated that 53.1% of patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and 20.4% met the histological criteria for NASH. Patients with T1DM onset at an earlier age have an increased incidence of cardiovascular disease (CVD) events and increased CVD mortality.
Matrix metalloproteinases (MMPs) are found to have multiple biological activities including diseases like angiogenesis and cirrhosis. They are expressed in atherosclerotic plaques, promoting vascular remodelling, contributing to atherothrombosis, and plaque disruption. MMP-14 is involved in the development of atherosclerosis and CVD. MMP-14 is also noticed to be expressed in highly invasive hepatocellular carcinoma and expressed in liver fibrosis.
Carotid ultrasound is easily available, a cost effective and non-invasive tool for evaluating carotid artery intima-media thickness (CIMT) to assess CVD as carotid atherosclerosis. CIMT was higher for individuals with NASH than for those with simple steatosis.
Dipeptidyl peptidase-4 (DPP-4) inhibitors are a relatively new class of oral diabetes drugs with a glucose-lowering effect. DPP-4 inhibitors exert their glucose-lowering effects primarily by blocking the enzyme DPP-4, which is involved in the degradation of incretins, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). DPP-4 inhibitors are widely used for the treatment of type 2 diabetes since 2006. Although DPP-4 inhibitors may be beneficial for T1DM, existing studies do not strongly support these positive effects in clinical practice.
Vildagliptin, an oral antihyperglycemic agent that competitively inhibits DPP-4. A few trials have demonstrated that vildagliptin has an effect on NAFLD. In 44 patients with T2DM and hepatic steatosis, vildagliptin treatment for 6 months decreased liver enzymes and intrahepatic triglyceride content, as assessed by MRI. In a study conducted in Pakistan, vildagliptin for 12 weeks improved liver enzymes and steatosis grading, as assessed by ultrasound.
Aim: To assess the effect of Dipeptidyl peptidase-4 (DPP-4) inhibitors supplementation as an add on therapy on NASH in adolescents with type 1 diabetes mellitus as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dipeptidyl peptidase-4 inhibitors supplementation | Active comparator | Drug: Dipeptidyl peptidase 4 (DPP-4) inhibitorIntervention group receiving Dipeptidyl peptidase-4 inhibitors supplementation |
| Control group | No intervention | –Control group not receiving Dipeptidyl peptidase-4 inhibitors supplementation |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescents diagnosed with type 1 diabetes according to ISPAD guidelines .
- Patients aged 12-18 years with NASH.
- Patients on regular visit to clinic.
- Patients on regular insulin therapy.
Key exclusion criteria (10 listed)
- Patients with renal impairment due to cause other than diabetes.
- Patients with hypertension.
- Hyper- or hypo-thyroidism.
- Hepatitis virus infection (B or C) or any evidence of infection.
- History of liver disease other than NASH such as cholestasis and Wilson 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 |
|---|---|---|
| Dipeptidyl peptidase 4 (DPP-4) inhibitorAlso: Dipeptidyl peptidase-4 inhibitorsIntervention group received Dipeptidyl peptidase-4 (DPP-4) inhibitors supplementation in a dose of 50 mg with main meal for 6 months. | Drug | Dipeptidyl peptidase-4 inhibitors supplementation |
Primary outcome
Number of participants with treatment-related effect on NASH status in adolescents with type 1 diabetes mellitus
Time frame: 6 months
Effect of DPP-4 inhibitors on NASH in adolescents with type 1 diabetes mellitus measured by Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) to assess liver stiffness and steatosis stage.
2 secondary outcomes
Number of participants with treatment-related Matrix metalloproteinase-14 (MMP-14) level change
Time frame: 6 months
Number of participants with treatment-related Glycemic control (HbA1c%) level change
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Results publication: PubMed 27314342Temple JL, Cordero P, Li J, Nguyen V, Oben JA. A Guide to Non-Alcoholic Fatty Liver Disease in Childhood and Adolescence. Int J Mol Sci. 2016 Jun 15;17(6):947. doi: 10.3390/ijms17060947.
- Results publication: PubMed 32998054Verges B. Cardiovascular disease in type 1 diabetes: A review of epidemiological data and underlying mechanisms. Diabetes Metab. 2020 Nov;46(6):442-449. doi: 10.1016/j.diabet.2020.09.001. Epub 2020 Sep 28.
- Results publication: PubMed 33737203Geervliet E, Moreno S, Baiamonte L, Booijink R, Boye S, Wang P, Voit B, Lederer A, Appelhans D, Bansal R. Matrix metalloproteinase-1 decorated polymersomes, a surface-active extracellular matrix therapeutic, potentiates collagen degradation and attenuates early liver fibrosis. J Control Release. 2021 Apr 10;332:594-607. doi: 10.1016/j.jconrel.2021.03.016. Epub 2021 Mar 15.
- Results publication: PubMed 16732016Targher G, Bertolini L, Padovani R, Rodella S, Zoppini G, Zenari L, Cigolini M, Falezza G, Arcaro G. Relations between carotid artery wall thickness and liver histology in subjects with nonalcoholic fatty liver disease. Diabetes Care. 2006 Jun;29(6):1325-30. doi: 10.2337/dc06-0135.
- Results publication: PubMed 32168769Sumida Y, Yoneda M, Tokushige K, Kawanaka M, Fujii H, Yoneda M, Imajo K, Takahashi H, Eguchi Y, Ono M, Nozaki Y, Hyogo H, Koseki M, Yoshida Y, Kawaguchi T, Kamada Y, Okanoue T, Nakajima A, Jsg-Nafld JSGON. Antidiabetic Therapy in the Treatment of Nonalcoholic Steatohepatitis. Int J Mol Sci. 2020 Mar 11;21(6):1907. doi: 10.3390/ijms21061907.
- Results publication: PubMed 29507862Wang Q, Long M, Qu H, Shen R, Zhang R, Xu J, Xiong X, Wang H, Zheng H. DPP-4 Inhibitors as Treatments for Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis. J Diabetes Res. 2018 Jan 8;2018:5308582. doi: 10.1155/2018/5308582. eCollection 2018.
- Results publication: PubMed 28083033Hussain M, Majeed Babar MZ, Hussain MS, Akhtar L. Vildagliptin ameliorates biochemical, metabolic and fatty changes associated with non alcoholic fatty liver disease. Pak J Med Sci. 2016 Nov-Dec;32(6):1396-1401. doi: 10.12669/pjms.326.11133.
- Individual participant dataSharing planned: Undecided
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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 Phase 3 study testing Dipeptidyl peptidase 4 (DPP-4) inhibitor in people with Diabetes Mellitus, Type 1 and NASH, run by Ain Shams 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 5 Apr 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with treatment-related effect on NASH status in adolescents with type 1 diabetes mellitus (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06348706, which also lists 7 linked publications.
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 5 Apr 2024.