AzTrials
AzTrials

NAFLDNCT06038253

Relation Between NAFLD and BM DENSITY

An observational study of NAFLD and Osteoporosis, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In general NAFLD is a common denominal for a broad spectrum of damage to the liver, which can be due to hepatocyte injury, inflammatory processes and fibrosis. This is normally seen on liver biopsy and can range from milder forms (steatosis) to the more severe forms (non-alcoholic steatohepatitis (NASH), advanced… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
NAFLD, Osteoporosis
What is being tested?
Fibroscan
Type of treatment
Medical device
How many people
100 participants
Where
No sites listed yet
Study dates
1 Oct 2023to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 50 years
  • All sexes
  • Adult

Study population: 1. Patients presented to obesity clinic for follow up 2. Patients presented to git clinic at Alrajhi hospital 3. Patients presented to fibroscan clinic for evaluation the degree of liver fibrosis and steatosis will be included in the study 4. Patients presented at radiology department for abd U.S and diagnosed accidentally fatty liver .

Who may be able to join

  • INCLUSION CRITERIA
  • Patients above the age of 18 y.o and premenopausal females
  • Patients showing any degree of fibrosis and steatosis .
  • Patients suffers from obesity and its complications
  • Patients with hyperlipidemia and DM
  • NAFLD patients were diagnosed with an ultrasound examination or fibroscan or pathological examination to make a clear and definite diagnosis,
  • all the obese participants according to body mass index (BMI)
  • BMD was measured by dual energy X-ray absorptiometry.

Who cannot join

  • 1- Patients less than 18 y.o 2- Patients known alcohol abuser of ≥30 g/day in men or≥20 g/day in women. 3- Patients with chronic liver disease or HCC. 4- Subjects with suspected or proven any other liver disease other than NAFLD as (viral hepatitis, drug-induced liver injury, autoimmune liver disease, Wilson's disease or primary biliary cholangitis).
  • 5- none of the subjects followed specific diets or therapeutic treatments that could influence BMD or liver function.
  • 6- Patients with conditions known to affect bone metabolism, such as kidney, thyroid or parathyroid diseases, bone tumors 7- (iv) Postmenopausal females to avoid the increased risk of osteoporosis in those patients due to hormonal changes.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mina Maged helmy habib, Reident of internal medecine contact

+201225760412

mon.maged@yahoo.com

Ahmed Mohammed mostafa ashmawy, Assistant professot contact

+201005679880

dr.ashmawy@yahoo.com

About this study

Official title: Relation Between Non- Alcoholic Fatty Liver Disease and Bone Mineral Density in Egyptian Adults

In general NAFLD is a common denominal for a broad spectrum of damage to the liver, which can be due to hepatocyte injury, inflammatory processes and fibrosis. This is normally seen on liver biopsy and can range from milder forms (steatosis) to the more severe forms (non-alcoholic steatohepatitis (NASH), advanced fibrosis, cirrhosis and liver failure). In these patients, advanced fibrosis is the major predictor of morbidity and liver-related mortality, and an accurate diagnosis of NASH and NAFLD is mandatory .

NAFLD is closely associated with metabolic disorders, including central obesity, dyslipidaemia, hypertension, hyperglycaemia and persistent abnormalities of liver function tests. NAFLD was shown to be connected with diseases that are usually not dependent on obesity, such as sarcopenia and osteoporosis

Read more

Target of the study :

  1. Clarify predictive value of fibroscan and u/s in diagnosis of NAFLD.
  2. Estimate the metabolic effect of NAFLD on bone density
  3. Estimate the correlation between obesity , NAFLD and BMD
Read the detailed description

INTRODUCTION:

In general, the prevalence of NAFLD has increased over the last 20 years. The Middle East and South America have the highest NAFLD prevalence at 31% and 32% respectively with the lowest prevalence in Africa at 13.5% .

NAFLD is closely associated with metabolic disorders, including central obesity, dyslipidaemia, hypertension, hyperglycaemia and persistent abnormalities of liver function tests. NAFLD was shown to be connected with diseases that are usually not dependent on obesity, such as sarcopenia and osteoporosis In general NAFLD is a common denominal for a broad spectrum of damage to the liver, which can be due to hepatocyte injury, inflammatory processes and fibrosis. This is normally seen on liver biopsy and can range from milder forms (steatosis) to the more severe forms (non-alcoholic steatohepatitis (NASH), advanced fibrosis, cirrhosis and liver failure). In these patients, advanced fibrosis is the major predictor of morbidity and liver-related mortality, and an accurate diagnosis of NASH and NAFLD is mandatory .

Osteoporosis is a group of bone diseases with various causes, including general factors related to aging, obesity and sex steroid deficiency, as well as specific risk factors such as the use of glucocorticoids, reduced bone quality, and disruption of microarchitectural integrity. In most cases of osteoporosis, the reduction in bone tissue is mainly due to increased bone resorption. Osteoporosis is characterized by low bone mineral density (BMD), bone pain and easy fracture.Osteoporosis is a silent disease until fractures occur with increasing frequency, which can cause important problems and even death. In industrialized countries, 9%-38% of women and 1%-8% of men >50 years suffer from osteoporosis.

Therefore, osteoporosis is not only harmful to health but also increases the financial burden of the impacted countries.

Many studies have demonstrated that NAFLD is associated with low BMD and osteoporosis.

Liver is the source of many proteins and is the regulator of several pathways involving bone metabolism; one of the most well-known of all is vitamin D metabolism pathway. Considering the role of liver in bone metabolism, the association between NAFLD and bone abnormalities is not surprising especially with substantial supporting evidences in recent years .

Besides its role in the calcium and bone metabolism, vitamin D may also exert pleiotropic effects in many tissues. NAFLD patients were reported to have a marked reduction in serum 25(OH) vitamin D when compared with control Liver biopsy remains the current gold standard for diagnosis of NAFLD, despite limitations regarding sampling variability, invasive nature, and high cost. However, numerous non-invasive biomarkers, including mainly serum markers or imaging modalities, intend to detect the presence of steatosis, NASH or advanced fibrosis. To date, ultrasound is suggested as first-line screening tool for defining steatosis in a selected population, while diagnosis of NAFLD requires exclusion of other chronic liver disease etiology or other steatosis causes and exclusion of alcohol intake by history .

Fibro scan becomes an evidence based , transient elastography instrument For noninvasive evaluation of liver steatosis and fibrosis , fibroscan is becoming an increasing important modality in NAFLD practice , as it was recently used to identify patients eligible for NAFLD related clinical trials

Target of the study :

  1. Clarify predictive value of fibroscan and u/s in diagnosis of NAFLD.
  2. Estimate the metabolic effect of NAFLD on bone density
  3. Estimate the correlation between obesity , NAFLD and BMD

STUDY DESIGN :

CROSS- SECTIONAL OBSERVATIONAL STUDY

Patients and methods :

  1. Patients presented to obesity clinic for follow up
  2. Patients presented to git clinic
  3. Patients presented to fibroscan clinic for evaluation the degree of liver fibrosis and steatosis will be included in the study
  4. Patients presented at radiology department for abd U.S and diagnosed accidentally fatty liver .

INCLUSION CRITERIA

  1. Patients above the age of 18 y.o and premenopausal females
  2. Patients showing any degree of fibrosis and steatosis .
  3. Patients suffers from obesity and its complications
  4. Patients with hyperlipidemia and diabetes mellitus .
  5. NAFLD patients were diagnosed with an ultrasound examination or fibroscan or pathological examination to make a clear and definite diagnosis,
  6. all the obese participants according to body mass index (BMI)
  7. BMD was measured by dual energy X-ray absorptiometry.

Exclusion criteria :

  1. Patients less than 18 y.o
  2. Patients known alcohol abuser of ≥30 g/day in men or≥20 g/day in women.
  3. Patients with chronic liver disease or hepatocellular carcinoma .
  4. Subjects with suspected or proven any other liver disease other than NAFLD as (viral hepatitis, drug-induced liver injury, autoimmune liver disease, Wilson's disease or primary biliary cholangitis).
  5. none of the subjects followed specific diets or therapeutic treatments that could influence BMD or liver function.
  6. Patients with conditions known to affect bone metabolism, such as kidney, thyroid or parathyroid diseases, bone tumors
  7. (iv) Postmenopausal females to avoid the increased risk of osteoporosis in those patients due to hormonal changes.
Conditions
NAFLD, Osteoporosis
Being tested
Fibroscan
Medical subject headings
Non-alcoholic Fatty Liver Disease, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FibroscanDevice

    Also called Dexa scan

    Fibroscan is device to detect degree of liver fibrosis in NAFLD patients Dexa scan device detect degree of osteoporosis in NAFLD patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of vit D level in serum in NAFLD patients

    To study level of vit D in NAFLD patients and its relation to disease severity

    Measured: 1 year

  2. Degree of osteoporosis in NAFLD patients

    Using dexa scan to detect level of osteoporosis in NAFLD patients

    Measured: 1 year

  3. Level of parathyroid hormone level in NAFLD PATIENTS

    Level of parathyroid hormone level in NAFLD PATIENTS and its relation to disease severity

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start1 Oct 2023 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06038253
Sponsor's protocol ID
NAFLD and bone mineral density
Status last verified
Sep 2023
First submitted
8 Sep 2023
Last updated
15 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sasso M, Audiere S, Kemgang A, Gaouar F, Corpechot C, Chazouilleres O, Fournier C, Golsztejn O, Prince S, Menu Y, Sandrin L, Miette V. Liver Steatosis Assessed by Controlled Attenuation Parameter (CAP) Measured with the XL Probe of the FibroScan: A Pilot Study Assessing Diagnostic Accuracy. Ultrasound Med Biol. 2016 Jan;42(1):92-103. doi: 10.1016/j.ultrasmedbio.2015.08.008. Epub 2015 Sep 19.

    PubMed 26386476
  • Ballestri S, Zona S, Targher G, Romagnoli D, Baldelli E, Nascimbeni F, Roverato A, Guaraldi G, Lonardo A. Nonalcoholic fatty liver disease is associated with an almost twofold increased risk of incident type 2 diabetes and metabolic syndrome. Evidence from a systematic review and meta-analysis. J Gastroenterol Hepatol. 2016 May;31(5):936-44. doi: 10.1111/jgh.13264.

    PubMed 26667191
  • Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.

    PubMed 24042449
  • Eshraghian A. Bone metabolism in non-alcoholic fatty liver disease: vitamin D status and bone mineral density. Minerva Endocrinol. 2017 Jun;42(2):164-172. doi: 10.23736/S0391-1977.16.02587-6. Epub 2016 Dec 14.

    PubMed 27973461
  • Poggiogalle E, Donini LM, Lenzi A, Chiesa C, Pacifico L. Non-alcoholic fatty liver disease connections with fat-free tissues: A focus on bone and skeletal muscle. World J Gastroenterol. 2017 Mar 14;23(10):1747-1757. doi: 10.3748/wjg.v23.i10.1747.

    PubMed 28348479

Questions about this trial

What is this clinical trial studying?

An observational study of NAFLD and Osteoporosis, 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 8 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 Sep 2023. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mina Maged helmy habib, Reident of internal medecine (+201225760412, mon.maged@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of vit D level in serum in NAFLD patients (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT06038253, which also lists 5 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 15 Sep 2023.

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