NCT05962099

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 27, 2023

Status Verified

May 1, 2023

Enrollment Period

3.3 years

First QC Date

May 22, 2023

Last Update Submit

July 18, 2023

Conditions

NAFLD

Outcome Measures

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

    12 hours

Secondary Outcomes (3)

  • Difference in morning and evening glucose production and disposal (of a labelled stable isotope tracer) during a two-step hyperinsulinaemic-euglycaemic clamp

    12 hours

  • Difference in morning and evening glucose oxidation measured by incorporation of 13C in breath CO2 across a 2-step hyperinsulinemia euglycaemic clamp

    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)

    12 weeks

Study Arms (2)

NAFLD

Behavioral: Lifestyle and weight loss advice

Controls (non-NAFLD)

Interventions

Lifestyle and weight loss adviceBEHAVIORAL

Commercially available lifestyle and weight loss intervention

NAFLD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Adipose and skeletal muscle tissue, urine, serum/plasma

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Jeremy Tomlinson

CONTACT

01865 857359jeremy.tomlinson@ocdem.ox.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

July 27, 2023

Study Start

March 1, 2021

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

July 27, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)