Atherosclerosis With Diabetes Mellitus and Fatty LiverNCT05532553
Relation Between Carotid Atheroscerosis With DM &Fatty Liver
An observational study of Atherosclerosis With Diabetes Mellitus and Fatty Liver, run by Assiut University.
Trial summary
To determine the risk of atherosclerosis in NAFLD patients who have T2DM by meauring Carotid intima media thickness (CIMT) using carotid doppler ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerosis With Diabetes Mellitus and Fatty Liver
- What is being tested?
- Carotid Doppler U/S
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Oct 2023
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: patients who will be presented to internal medicine department\& outpatient clinics at Assiut university hospital divided into 2 groups. Group 1:Patient with T2DM and fatty liver. Group 2: patients with fatty liver only ( control group). Carotid doppler ultrasonography will be considered for both groups to measure Carotid Intima Media Thickness (CIMT).
Who may be able to join
- Patients with fatty liver (diabetic\& not diabetic).
Who cannot join
- 1-Other causes of Liver disease ( (viral hepatitis, drug-induced liver disease, hepatolenticular degeneration, autoimmune liver disease, schistosomiasis liver disease, cirrhosis, etc.) 2- Heavy smoker.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Association Between Carotid Atherosclerosis and Fatty Liver Index in Patients With Type 2 Diabetes Mellitus
To determine the risk of atherosclerosis in NAFLD patients who have T2DM by meauring Carotid intima media thickness (CIMT) using carotid doppler ultrasound.
Read the detailed description
Fatty liver is one of the most common chronic liver diseases in the world. It's prevalence is reported to be 10-40% in the adult populations. At least 57% to 80% of them are associated with diabetes (1.2).Atherosclerosis and cardiovascular diseases are also highly prevalent in this group of patients(10).
Non-alcoholic fatty liver disease ( NAFLD) is characterized pathophysiological by hepatic fat accumulation independent of excessive alcohol use(3.4). Fatty liver index (FLI) has been demonstrated good diagnostic accuracy in different populations(6.7)...FLI will be based on BMI, waist circumference (WC), triacylglycerols (TG) and g-glutamyl transferase (GGT).
The individuals with NAFLD have a higher risk of 10-year cardiovascular events than healthy individuals.(10) .NAFLD and T2DM are common conditions that regularly co-exist and can act synergistically to drive adverse outcomes(5). Diabetic macrovascular complications are the major chronic complications and the leading cause of death among the patients with T2DM, of which the pathological basis is atherosclerosis.(8) Atherosclerosis usually starts in the vascular intima, progressing to the medial arterial wall(9).Carotid intima-media thickness (CIMT) is an indicator of the risk of vascular disease. Increased CIMT and presence of atherosclerotic plaque are considered as a reliable ultrasound biomarker of subclinical atherosclerosis and can be used for cardiovascular risk assessment[9].
In this study the investigators have the aim of evaluating the possible association between non-invasive index of fatty liver (FLI) and the presence of carotid atherosclerosis in T2DM.
- Being tested
- Carotid Doppler U/S
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Doppler U/SDevice
Measurement of carotid intima media thickness by carotid doppler ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patient with T2DM and fatty liver. Receives: Device: Carotid Doppler U/S | |
| Group 2 | patients with fatty liver only ( control group). Receives: Device: Carotid Doppler U/S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of carotid atherosclerosis
To determine the risk of atherosclerosis in NAFLD patients who have T2DM by measuring CIMT using carotid doppler ultrasound.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atherosclerosis With Diabetes Mellitus and Fatty LiverStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ehab Makram, Assiut University
- Investigators
- Walaa Anwar Mohamed Khalifa, Doctor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532553
- Sponsor's protocol ID
- Atherosclerosis With DM&fatty
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pereira K, Salsamendi J, Casillas J. The Global Nonalcoholic Fatty Liver Disease Epidemic: What a Radiologist Needs to Know. J Clin Imaging Sci. 2015 May 29;5:32. doi: 10.4103/2156-7514.157860. eCollection 2015.
PubMed 26167390Younossi ZM. Non-alcoholic fatty liver disease - A global public health perspective. J Hepatol. 2019 Mar;70(3):531-544. doi: 10.1016/j.jhep.2018.10.033. Epub 2018 Nov 9.
PubMed 30414863Benedict M, Zhang X. Non-alcoholic fatty liver disease: An expanded review. World J Hepatol. 2017 Jun 8;9(16):715-732. doi: 10.4254/wjh.v9.i16.715.
PubMed 28652891Rinella ME, Sanyal AJ. NAFLD in 2014: Genetics, diagnostics and therapeutic advances in NAFLD. Nat Rev Gastroenterol Hepatol. 2015 Feb;12(2):65-6. doi: 10.1038/nrgastro.2014.232. Epub 2015 Jan 6.
PubMed 25560844Hazlehurst JM, Woods C, Marjot T, Cobbold JF, Tomlinson JW. Non-alcoholic fatty liver disease and diabetes. Metabolism. 2016 Aug;65(8):1096-108. doi: 10.1016/j.metabol.2016.01.001. Epub 2016 Jan 11.
PubMed 26856933Lee JH, Kim D, Kim HJ, Lee CH, Yang JI, Kim W, Kim YJ, Yoon JH, Cho SH, Sung MW, Lee HS. Hepatic steatosis index: a simple screening tool reflecting nonalcoholic fatty liver disease. Dig Liver Dis. 2010 Jul;42(7):503-8. doi: 10.1016/j.dld.2009.08.002. Epub 2009 Sep 18.
PubMed 19766548Bedogni G, Bellentani S, Miglioli L, Masutti F, Passalacqua M, Castiglione A, Tiribelli C. The Fatty Liver Index: a simple and accurate predictor of hepatic steatosis in the general population. BMC Gastroenterol. 2006 Nov 2;6:33. doi: 10.1186/1471-230X-6-33.
PubMed 17081293Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
PubMed 29219149Stein JH, Tattersall MC. Carotid intima-media thickness and cardiovascular disease risk prediction. J Am Coll Cardiol. 2014 Jun 3;63(21):2301-2. doi: 10.1016/j.jacc.2014.02.528. Epub 2014 Mar 5. No abstract available.
PubMed 24613323Wojcik-Cichy K, Koslinska-Berkan E, Piekarska A. The influence of NAFLD on the risk of atherosclerosis and cardiovascular diseases. Clin Exp Hepatol. 2018 Mar;4(1):1-6. doi: 10.5114/ceh.2018.73155. Epub 2018 Jan 20.
PubMed 29594192
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Carotid Atherosclerosis and Fatty Liver Index in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05532553
- Acronym / sponsor ID
- Atherosclerosis With DM&fatty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Sep 2022 (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.
To determine the risk of atherosclerosis in NAFLD patients who have T2DM by meauring Carotid intima media thickness (CIMT) using carotid doppler ultrasound.
Detailed description
Fatty liver is one of the most common chronic liver diseases in the world. It's prevalence is reported to be 10-40% in the adult populations. At least 57% to 80% of them are associated with diabetes (1.2).Atherosclerosis and cardiovascular diseases are also highly prevalent in this group of patients(10).
Non-alcoholic fatty liver disease ( NAFLD) is characterized pathophysiological by hepatic fat accumulation independent of excessive alcohol use(3.4). Fatty liver index (FLI) has been demonstrated good diagnostic accuracy in different populations(6.7)...FLI will be based on BMI, waist circumference (WC), triacylglycerols (TG) and g-glutamyl transferase (GGT).
The individuals with NAFLD have a higher risk of 10-year cardiovascular events than healthy individuals.(10) .NAFLD and T2DM are common conditions that regularly co-exist and can act synergistically to drive adverse outcomes(5). Diabetic macrovascular complications are the major chronic complications and the leading cause of death among the patients with T2DM, of which the pathological basis is atherosclerosis.(8) Atherosclerosis usually starts in the vascular intima, progressing to the medial arterial wall(9).Carotid intima-media thickness (CIMT) is an indicator of the risk of vascular disease. Increased CIMT and presence of atherosclerotic plaque are considered as a reliable ultrasound biomarker of subclinical atherosclerosis and can be used for cardiovascular risk assessment[9].
In this study the investigators have the aim of evaluating the possible association between non-invasive index of fatty liver (FLI) and the presence of carotid atherosclerosis in T2DM.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Carotid Doppler U/SPatient with T2DM and fatty liver. |
| Group 2 | – | Device: Carotid Doppler U/Spatients with fatty liver only ( control group). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who will be presented to internal medicine department\& outpatient clinics at Assiut university hospital divided into 2 groups. Group 1:Patient with T2DM and fatty liver. Group 2: patients with fatty liver only ( control group). Carotid doppler ultrasonography will be considered for both groups to measure Carotid Intima Media Thickness (CIMT).
Key inclusion criteria (1 listed)
- Patients with fatty liver (diabetic\& not diabetic).
Key exclusion criteria (1 listed)
- 1-Other causes of Liver disease ( (viral hepatitis, drug-induced liver disease, hepatolenticular degeneration, autoimmune liver disease, schistosomiasis liver disease, cirrhosis, etc.) 2- Heavy smoker.
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 |
|---|---|---|
| Carotid Doppler U/SMeasurement of carotid intima media thickness by carotid doppler ultrasound | Device | Group 1, Group 2 |
Primary outcome
Assessment of carotid atherosclerosis
Time frame: baseline
To determine the risk of atherosclerosis in NAFLD patients who have T2DM by measuring CIMT using carotid doppler ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 26167390Pereira K, Salsamendi J, Casillas J. The Global Nonalcoholic Fatty Liver Disease Epidemic: What a Radiologist Needs to Know. J Clin Imaging Sci. 2015 May 29;5:32. doi: 10.4103/2156-7514.157860. eCollection 2015.
- Background: PubMed 30414863Younossi ZM. Non-alcoholic fatty liver disease - A global public health perspective. J Hepatol. 2019 Mar;70(3):531-544. doi: 10.1016/j.jhep.2018.10.033. Epub 2018 Nov 9.
- Background: PubMed 28652891Benedict M, Zhang X. Non-alcoholic fatty liver disease: An expanded review. World J Hepatol. 2017 Jun 8;9(16):715-732. doi: 10.4254/wjh.v9.i16.715.
- Background: PubMed 25560844Rinella ME, Sanyal AJ. NAFLD in 2014: Genetics, diagnostics and therapeutic advances in NAFLD. Nat Rev Gastroenterol Hepatol. 2015 Feb;12(2):65-6. doi: 10.1038/nrgastro.2014.232. Epub 2015 Jan 6.
- Background: PubMed 26856933Hazlehurst JM, Woods C, Marjot T, Cobbold JF, Tomlinson JW. Non-alcoholic fatty liver disease and diabetes. Metabolism. 2016 Aug;65(8):1096-108. doi: 10.1016/j.metabol.2016.01.001. Epub 2016 Jan 11.
- Background: PubMed 19766548Lee JH, Kim D, Kim HJ, Lee CH, Yang JI, Kim W, Kim YJ, Yoon JH, Cho SH, Sung MW, Lee HS. Hepatic steatosis index: a simple screening tool reflecting nonalcoholic fatty liver disease. Dig Liver Dis. 2010 Jul;42(7):503-8. doi: 10.1016/j.dld.2009.08.002. Epub 2009 Sep 18.
- Background: PubMed 17081293Bedogni G, Bellentani S, Miglioli L, Masutti F, Passalacqua M, Castiglione A, Tiribelli C. The Fatty Liver Index: a simple and accurate predictor of hepatic steatosis in the general population. BMC Gastroenterol. 2006 Nov 2;6:33. doi: 10.1186/1471-230X-6-33.
- Background: PubMed 29219149Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
- Background: PubMed 24613323Stein JH, Tattersall MC. Carotid intima-media thickness and cardiovascular disease risk prediction. J Am Coll Cardiol. 2014 Jun 3;63(21):2301-2. doi: 10.1016/j.jacc.2014.02.528. Epub 2014 Mar 5. No abstract available.
- Background: PubMed 29594192Wojcik-Cichy K, Koslinska-Berkan E, Piekarska A. The influence of NAFLD on the risk of atherosclerosis and cardiovascular diseases. Clin Exp Hepatol. 2018 Mar;4(1):1-6. doi: 10.5114/ceh.2018.73155. Epub 2018 Jan 20.
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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.
Walaa Anwar Mohamed Khalifa, Doctor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis With Diabetes Mellitus and Fatty Liver, run by Assiut University.
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 1 inclusion and 1 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 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dina Ehab Makram, Resident doctor (01288852317, dina.ehab50@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of carotid atherosclerosis (time frame: baseline). 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 NCT05532553, which also lists 10 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 10 Sep 2022.