Defining Circadian Metabolism in Non-alcoholic Fatty Liver Disease

NAFLD Clinical Trial

— DECIMAL  

Official title:

Defining Circadian Metabolism in Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962099
• Other study ID #: 15296
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: University of Oxford
• Contact: Jeremy Tomlinson
• Phone: 01865 857359
• Email: jeremy.tomlinson[@]ocdem.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will conduct an open label, experimental medicine study exploring the diurnal patterns of hepatic lipid metabolism in NAFLD and non-NAFLD participants (determined by Transient elastography (TE) with controlled attenuation parameter (CAP)). We will also determine whether the diurnal patterns of lipid metabolism in NAFLD participants can be modified using lifestyle and weight loss intervention. Fourteen participants without NAFLD will have morning and evening metabolic investigations (visit 1M & 1E) to assess for changes in lipid flux pathways across the course of the day. After morning and evening investigations their involvement in the clinical study will then end. Seventeen NAFLD participants will also have identical baseline morning and evening investigation after which they will be enrolled into a 12-week lifestyle and weight loss programme. After 12-weeks, all 17 participants with NAFLD will have a follow up CAP, and morning and evening metabolic investigations (visit 2M & 2E).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female

• BMI 25-50 kg/m2

• Age 18-75 years

Exclusion Criteria:

• A diagnosis of type 1 diabetes

• Type 2 diabetes controlled with medications other than metformin (within last 3 months)

• Shift working patterns in last 3-months or if likely to work shifts during study period.

• Current or recent (<3-months) use of weight loss medications

• Current or recent use of oral contraceptive pill or hormone replacement therapy (within last 3-months)

• Pregnancy

• A blood haemoglobin <120mg/dL

• History of alcoholism or a greater than recommended alcohol intake (Recommendations > 21 units on average per week for men and > 14 units on average per week for women)

• Haemorrhagic disorders

• Treatment with anticoagulant agents

• Other co-morbidities that in the eyes of the investigators may affect data collection

• Any medical condition in the opinion of the investigator that might impact upon safety or validity of the results

• Transient elastography (TE) controlled attenuation parameter (CAP) of between 216-305 dB/m

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• Lifestyle and weight loss advice
Commercially available lifestyle and weight loss intervention

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hepatic fatty acid synthesis as measured by incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) between morning and evening		12 hours
Secondary	Difference in morning and evening glucose production and disposal (of a labelled stable isotope tracer) during a two-step hyperinsulinaemic-euglycaemic clamp		12 hours
Secondary	Difference in morning and evening glucose oxidation measured by incorporation of 13C in breath CO2 across a 2-step hyperinsulinemia euglycaemic clamp		12 hours
Secondary	Changes in diurnal patterns of hepatic fatty acid synthesis after weight loss programme (measured by incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG)		12 weeks