Relation Between NAFLD and BM DENSITY

NCT06038253 | Not Yet Recruiting

• 1 other identifier: NAFLD and bone mineral density
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 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 Target of the study :

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

Conditions

NAFLD; Osteoporosis

Outcome Measures

Primary Outcomes (3)

• 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

  1 year

• Degree of osteoporosis in NAFLD patients

  Using dexa scan to detect level of osteoporosis in NAFLD patients

  1 year

• Level of parathyroid hormone level in NAFLD PATIENTS

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

  1 year

Interventions

Fibroscan DEVICE

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

Also known as: Dexa scan

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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 .

You may qualify if:

• 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.

You may not qualify if:

• 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).
• none of the subjects followed specific diets or therapeutic treatments that could influence BMD or liver function.
• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 26386476 BACKGROUND

• 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.

  PMID: 26667191 BACKGROUND

• 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.

  PMID: 24042449 RESULT

• 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.

  PMID: 27973461 RESULT

• 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.

  PMID: 28348479 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Osteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ghada Abdelrahman alkhateeb, Professor

  Assiut University

  STUDY DIRECTOR

• Ahmed Mohammed mostafa ashmawy, Assistant professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2023

Record last verified: 2023-09