Trials / Unknown
UnknownNCT05962099
Defining Circadian Metabolism in Non-alcoholic Fatty Liver Disease
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 31 (estimated)
- Sponsor
- University of Oxford · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- —
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Lifestyle and weight loss advice | Commercially available lifestyle and weight loss intervention |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2024-06-01
- Completion
- 2024-06-01
- First posted
- 2023-07-27
- Last updated
- 2023-07-27
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05962099. Inclusion in this directory is not an endorsement.