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Status unknownNCT05962099DECIMALUpdated Jul 27, 2023

Defining Circadian Metabolism in Non-alcoholic Fatty Liver Disease

An observational study in NAFLD, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by University of Oxford · Observational

The sponsor has not verified this record recently (last verified May 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
31
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • NAFLD
03

In context

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 31 is below the median of 150 across 359 observational studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

Browse University of Oxford studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female
  • BMI 25-50 kg/m2
  • Age 18-75 years

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
31 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • NAFLD

    Behavioral: Lifestyle and weight loss advice

  • Controls (non-NAFLD)

Interventions

  • BehavioralLifestyle and weight loss advice

    Commercially available lifestyle and weight loss intervention

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 of 1 sites recruiting
  • University of Oxford
    Oxford, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2021 (actual). Primary completion is estimated for Jun 2024, 39 months after the start.

Of 143 non-industry observational studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 125. This study's planned 39 months is below that.

Counting every sponsor, half of 155 studies reached it within 49 months; a quarter within 23 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2023
First posted
Jul 27, 2023
StartActual
Mar 1, 2021
Primary completionEst.
Jun 1, 2024
CompletionEst.
Jun 1, 2024
Last update
Jul 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05962099
Lead sponsor
University of Oxford
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Mar 1, 2021
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Jul 27, 2023

Study contacts

Jeremy Tomlinson
Contact
jeremy.tomlinson@ocdem.ox.ac.uk
01865 857359

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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