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Clinical Trials/NCT06666894
NCT06666894
Completed
Not Applicable

Intermittent Fasting Versus Dietary Approach to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients

Cairo University1 site in 1 country40 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fasting, Intermittent
Sponsor
Cairo University
Enrollment
40
Locations
1
Primary Endpoint
assessment of Non-alcoholic fatty liver using ultrasonography
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study was conducted to compare between the effect of intermittent fasting and diatery approach to stop hypertension on metabolic risk profile in nonalcoholic fatty liver patients.

Detailed Description

Non-alcoholic fatty liver is a liver disease linked to obesity, insulin resistance, type 2 diabetes, hypertension, hyperlipidemia, and metabolic syndrome. The subtype, non-alcoholic steatohepatitis, can lead to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver transplantation. The prevalence of Non-alcoholic fatty liver disease is increasing at the same rate as obesity, with the global prevalence estimated at 25%. By 2020, the burden of Non-alcoholic fatty liver is expected to exceed that of communicable disease in most regions.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
June 1, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aya Gamal Khattab Omer

principal investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Non-alcoholic fatty liver patients diagnosed by radiological ultrasound
  • All patients are sedentary lifestyle with little or no exercise.
  • High lipid profile (total cholesterol \> 200, LDL \> 130, TAGs \> 150) patients by laboratory investigation.
  • High fasting insulin level \> 20mlU/mL \& high fasting Glucose level \>100, HbA1c \> 5.7 \& high HOMA- IR \> 2.5 patients by Laboratory investigation.
  • High inflammatory markers (IL6) patients.
  • Age ranged from 30 to 40 years old.

Exclusion Criteria

  • Alcoholic fatty liver patients.
  • Cirrhosis patients.
  • Diabetes patients.
  • Cognitive impaired patients.
  • History of epilepsy patients.
  • Cardiac pacemaker patients.
  • Anemic patients
  • pregnancy

Outcomes

Primary Outcomes

assessment of Non-alcoholic fatty liver using ultrasonography

Time Frame: at baseline at after two months

usage of diagnostic ultrasound to diagnose patients with non-alcoholic fatty liver disease

Secondary Outcomes

  • assessment of change of lab profile using laboratory investigations(at baseline at after two months)
  • assessment of change of body mass index(at baseline at after two months)
  • assessment of macronutrients distribution(at baseline at after two months)

Study Sites (1)

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