N/A
N=60
Effect of Intermittent Calorie Restriction on MASLD Patients With Abnormal Glucose Metabolism
Fatty Liver Disease · Type 2 Diabetes · Impaired Glucose Regulation
Bottom Line
View on ClinicalTrials.gov: NCT04283942 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change of Liver Fat Content in % — -20.5; -15.5; -7.6; -7.3 absolute fat content change in %
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intermittent calorie restriction (ICR) (Behavioral); Continuous calorie restriction (CCR) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shanghai Zhongshan Hospital
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Liver Fat Content in % |
-20.5; -15.5; -7.6; -7.3 | — |
| SECONDARY Change of Weight |
-5.3; -3.8 | — |
| SECONDARY Change of Blood Glucose: Fasting Blood Glucose |
-12.6; -10.8 | — |
| SECONDARY Change of Blood Glucose: 2h Postload Blood Glucose |
-50.6; -71.6 | — |
| SECONDARY Change of HbA1c |
-0.5; -0.1 | — |
| SECONDARY Change of Liver Enzymes: Alanine Aminotransferase |
-24.8; -10.1 | — |
| SECONDARY Change of Liver Enzymes: Aspartate Aminotransferase |
-11.5; -4.3 | — |
| SECONDARY Change of Liver Enzymes: γ-glutamyl Transpeptidase |
-16.5; -6.3 | — |
| SECONDARY Change of Lipid Profile: Total Cholesterol |
-3.9; -4.6 | — |
| SECONDARY Change of Lipid Profile: Triglyceride |
-24.8; -45.1 | — |
| SECONDARY Change of Lipid Profile: High-density Lipoprotein-cholesterol |
5.8; 1.2 | — |
| SECONDARY Change of Lipid Profile: Low-density Lipoprotein-cholesterol |
-4.6; 0.8 | — |
| SECONDARY Change of Lipid Profile: Free Fatty Acid |
-1.7; -1.4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04283942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.