Type 2 Diabetes Clinical Trial
Official title:
Effect of Intermittent Calorie Restriction on Metabolic Dysfunction-Associated Steatotic Liver Disease Patients With Abnormal Glucose Metabolism
NCT number | NCT04283942 |
Other study ID # | B2019-256R |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2020 |
Est. completion date | July 25, 2021 |
Verified date | September 2023 |
Source | Shanghai Zhongshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 25, 2021 |
Est. primary completion date | July 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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): 1. Impaired glucose regulation: fasting blood glucose = 100 mg/dL, postprandial blood glucose = 140 mg/dL or HbA1c = 5.7% 2. 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 |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital, Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of fat mass | measured by bioimpedance analyzer, fat mass in kilograms. | 12 weeks | |
Other | Change of lean mass | measured by bioimpedance analyzer, skeletal muscle mass in kilograms. | 12 weeks | |
Other | Change of abdominal adiposity | measured by MRI, including visceral adipose tissue and subcutaneous adipose tissue, all in square centimetres. | 12 weeks | |
Other | Change of liver stiffness measure of liver transient elastography | Change of liver stiffness measure of liver transient elastography, in kPa. | 12 weeks | |
Other | Change of insulin sensitivity | Change of HOMA-IR (fasting glucose in mmol/L x fasting insulin in µU/mL)/22.5). | 12 weeks | |
Other | Change of fasting insulin | Change of fasting insulin in µU/mL. | 12 weeks | |
Other | Change of brain functional MRI | Brain functional MRI will be used to evaluate the neural activity of the brain. | 12 weeks | |
Primary | Change of liver fat content in % | Change of liver fat content in %. | 12 weeks | |
Secondary | Change of weight | Change of weight in kilograms. | 12 weeks | |
Secondary | Change of blood glucose: fasting blood glucose | Change of fasting blood glucose in mmol/L. | 12 weeks | |
Secondary | Change of blood glucose: 2h postload blood glucose | Change of 2h postload blood glucose in mmol/L. | 12 weeks | |
Secondary | Change of HbA1c | Change of HbA1c in %. | 12 weeks | |
Secondary | Change of liver enzymes: alanine aminotransferase | Change of alanine aminotransferase in U/L. | 12 weeks | |
Secondary | Change of liver enzymes: aspartate aminotransferase | Change of aspartate aminotransferase in U/L. | 12 weeks | |
Secondary | Change of liver enzymes: ?-glutamyl transpeptidase | Change of ?-glutamyl transpeptidase in U/L. | 12 weeks | |
Secondary | Change of lipid profile: total cholesterol | Change of total cholesterol in mmol/L. | 12 weeks | |
Secondary | Change of lipid profile: triglyceride | Change of triglyceride in mmol/L. | 12 weeks | |
Secondary | Change of lipid profile: high-density lipoprotein-cholesterol | Change of high-density lipoprotein-cholesterol in mmol/L. | 12 weeks | |
Secondary | Change of lipid profile: low-density lipoprotein-cholesterol | Change of low-density lipoprotein-cholesterol in mmol/L. | 12 weeks | |
Secondary | Change of lipid profile: free fatty acid | Change of free fatty acid in mmol/L. | 12 weeks |
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