Status:
COMPLETED
Effect of Intermittent Calorie Restriction on MASLD Patients With Abnormal Glucose Metabolism
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Fatty Liver Disease
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is designed to observe the effect of 5:2 intermittent calorie restriction (fasting 2 days each week) on liver fat content in MASLD patients with abnormal blood glucose.
Detailed Description
Intermittent caloric restriction (ICR) can effectively reduce weight and facilitate blood glucose control, but whether it can be applied for clinical treatment to metabolic dysfunction-associated stea...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 18-70
- Diagnosed as fatty liver by ultrasound or magnetic resonance imaging
- BMI ≥ 24 kg/m2
- abnormal glucose metabolism: (meeting at least one):
- Impaired glucose regulation: fasting blood glucose ≥ 100 mg/dL, postprandial blood glucose ≥ 140 mg/dL or HbA1c ≥ 5.7%
- Diabetes mellitus: diabetic symptoms + plasma glucose concentration ≥ 200 mg/dL at any time or fasting plasma glucose concentration ≥ 100 mg/dL or OGTT 2 h plasma glucose concentration ≥ 200 mg/dL
- Exclusion Criteria
- Type 1 diabetes, gestational diabetes and other special types of diabetes
- Poor blood glucose control, HbA1c \> 8.5% within 3 months
- Taking antidiabetic drugs in the past month
- Serum ALT \> 6 times of normal upper limit
- Excessive alcohol consumption (alcohol intake: men \> 140 g, women \> 70 g in the past 6 months)
- Other liver diseases: such as acute and chronic viral hepatitis, drug-induced hepatitis, immune hepatitis, liver cirrhosis, liver cancer, etc
- Taking drugs that may affect MASLD in the past three months, such as vitamin E
- Biliary obstructive diseases
- Other diseases affecting glucose and lipid metabolism: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc
- Chronic kidney disease (serum creatinine ≥ 2.0 mg/dL)
- Life expectancy of no more than 5 years
- Already pregnant or plan to be pregnant in the near future
- Mental illness
- Other conditions affecting follow-up
- Have participated in other clinical trials in the past 4 weeks
- Absent of informed consent
Exclusion
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04283942
Start Date
July 30 2020
End Date
July 25 2021
Last Update
September 23 2024
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, China