Defining Circadian Metabolism in Non-alcoholic Fatty Liver Disease (DECIMAL)

July 18, 2023 updated by: University of Oxford
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

NAFLD participants Confirmed by transient elastography (TE) with controlled attenuation parameter (CAP) ≥306 dB/m

Non-NAFLD Confirmed by transient elastography (TE) with controlled attenuation parameter (CAP) ≤215 dB/m

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NAFLD
Behavioral: Lifestyle and weight loss advice
Commercially available lifestyle and weight loss intervention
Controls (non-NAFLD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 hours
12 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in morning and evening glucose production and disposal (of a labelled stable isotope tracer) during a two-step hyperinsulinaemic-euglycaemic clamp
Time Frame: 12 hours
12 hours
Difference in morning and evening glucose oxidation measured by incorporation of 13C in breath CO2 across a 2-step hyperinsulinemia euglycaemic clamp
Time Frame: 12 hours
12 hours
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)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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