Relation Between NAFLD and BM DENSITY
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ClinicalTrials.gov Identifier: NCT06038253 |
Recruitment Status :
Not yet recruiting
First Posted : September 14, 2023
Last Update Posted : September 15, 2023
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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 :
- Clarify predictive value of fibroscan and u/s in diagnosis of NAFLD.
- Estimate the metabolic effect of NAFLD on bone density
- Estimate the correlation between obesity , NAFLD and BMD
Condition or disease | Intervention/treatment |
---|---|
NAFLD Osteoporosis | Device: Fibroscan |
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Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Relation Between Non- Alcoholic Fatty Liver Disease and Bone Mineral Density in Egyptian Adults |
Estimated Study Start Date : | October 1, 2023 |
Estimated Primary Completion Date : | October 1, 2026 |
Estimated Study Completion Date : | December 1, 2026 |
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- Device: Fibroscan
Fibroscan is device to detect degree of liver fibrosis in NAFLD patients Dexa scan device detect degree of osteoporosis in NAFLD patientsOther Name: Dexa scan
- Level of vit D level in serum in NAFLD patients [ Time Frame: 1 year ]To study level of vit D in NAFLD patients and its relation to disease severity
- Degree of osteoporosis in NAFLD patients [ Time Frame: 1 year ]Using dexa scan to detect level of osteoporosis in NAFLD patients
- Level of parathyroid hormone level in NAFLD PATIENTS [ Time Frame: 1 year ]Level of parathyroid hormone level in NAFLD PATIENTS and its relation to disease severity
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
- Patients presented to obesity clinic for follow up
- Patients presented to git clinic at Alrajhi hospital
- Patients presented to fibroscan clinic for evaluation the degree of liver fibrosis and steatosis will be included in the study
- Patients presented at radiology department for abd U.S and diagnosed accidentally fatty liver .
Inclusion Criteria:
- 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.
Exclusion Criteria:
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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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06038253
Contact: Mina Maged helmy habib, Reident of internal medecine | +201225760412 | mon.maged@yahoo.com | |
Contact: Ahmed Mohammed mostafa ashmawy, Assistant professot | +201005679880 | dr.ashmawy@yahoo.com |
Study Director: | Ghada Abdelrahman alkhateeb, Professor | Assiut University | |
Study Director: | Ahmed Mohammed mostafa ashmawy, Assistant professor | Assiut University |
Other Publications:
Responsible Party: | Mina maged helmy habib, Resident doctor, Assiut University |
ClinicalTrials.gov Identifier: | NCT06038253 |
Other Study ID Numbers: |
NAFLD and bone mineral density |
First Posted: | September 14, 2023 Key Record Dates |
Last Update Posted: | September 15, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |