Defining Circadian Metabolism in Non-alcoholic Fatty Live... | NCT05962099

Studies
Defining Circadian Metabolism in Non-alcoholic Fatty Liver Disease

NCT05962099

Sponsor

University of Oxford

Status

Unknown status

Last Update Posted

Jul 27, 2023Actual

Enrollment

31Estimated

Phase

Not provided

Conditions

NAFLD

Interventions

Lifestyle and weight loss advice

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

May 22, 2023

First Submission Date that Met QC Criteria

Jul 18, 2023

First Posted Date

Jul 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2023

Last Update Posted Date

Jul 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

31Estimated

Name	Type	Description	Arm Group Labels	Other Names
Lifestyle and weight loss advice	Behavioral	Commercially available lifestyle and weight loss intervention	NAFLD

Outcomes Module

Primary Outcomes

Measure	Description	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		12 hours

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Jeremy Tomlinson	Contact	01865 857359		jeremy.tomlinson@ocdem.ox.ac.uk

Facility	Status	City	State	ZIP	Country	Contacts
University of Oxford	Recruiting	Oxford			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Label	Type	Description	Intervention Names
NAFLD			Behavioral: Lifestyle and weight loss advice
Controls (non-NAFLD)