NCT04004273

Brief Summary

This randomised controlled trial will determine if exercise (150 - 200 min per week, 6 weeks) can beneficially modify liver fat quality in non alcohol fatty liver disease patients with type 2 diabetes mellitus (n = 26, 13 per group). Liver fat quality will be assessed via magnetic resonance (3T) spectroscopy (1H-MRS) using validated methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

3.7 years

First QC Date

August 7, 2018

Last Update Submit

October 4, 2022

Conditions

Type 2 Diabetes MellitusNon-Alcoholic Fatty Liver DiseaseObesityInsulin ResistanceLiver DiseasesFatty LiverDiabetes MellitusGlucose Metabolism DisordersGlucose IntoleranceMetabolic Disease

Keywords

Type 2 diabetesNon-alcohol fatty liver diseaseExerciseSaturated fatMRIProton magnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Change in liver saturated lipid index (%) determined by proton magnetic resonance spectroscopy (1H-MRS) using a 3T MRI scanner

    Response to a six week exercise training intervention

    2 measurements: Baseline, week 6

Secondary Outcomes (21)

  • Change in Liver unsaturated lipid index (%) - measured using 1H-MRS

    2 measurements: Baseline, week 6

  • Change in Liver polyunsaturated lipid index (%) - measured using 1H-MRS

    2 measurements: Baseline, week 6

  • Change in total hepatic lipid composition (%) - measured using 1H-MRS

    2 measurements: Baseline, week 6

  • Change in visceral adipose tissue - measured using magnetic resonance imaging (MRI) with a 3T Philips Ingenia MRI scanner

    2 measurements: Baseline, week 6

  • Change in subcutaneous abdominal adipose tissue - measured using magnetic resonance imaging (MRI) with a 3T Philips Ingenia MRI scanner

    2 measurements: Baseline, week 6

  • +16 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Participants randomised to the exercise training intervention will complete 24 moderate-intensity exercise training sessions over the subsequent six weeks (four times per week; \~50 min per session). Each week, one exercise training session will be supervised by the research team, whilst three sessions will be unsupervised but monitored objectively using a heart rate monitor.

Behavioral: Exercise

Control

NO INTERVENTION

Participants randomised to control will receive no interventions and will be requested to maintain their habitual lifestyle during the six week intervention phase

Interventions

ExerciseBEHAVIORAL

24 moderate-intensity exercise training sessions over six weeks (four times per week; \~50 min per session)

Exercise

Eligibility Criteria

Age30 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men
  • ≥ 30 - ≤ 75 years of age
  • Body mass index ≥ 27 - ≤ 45 kg/m2 (or ≥ 23 to 45 45 kg/m2 if south Asian)
  • Waist circumference ≥ 94 cm (or ≥ 90 cm if south Asian)
  • Clinically elevated liver fat (≥ 5.56% assessed via 1H-MRS)
  • Participant is willing and able to give informed consent to participate
  • Participant can communicate effectively in English
  • Participant is able to meet the time demands of the study
  • Additional criteria for participants without T2DM:
  • HbA1c \> 6.0%
  • Additional criteria for participants with T2DM/prediabetes:
  • Diagnosed T2DM or prediabetes
  • Treatment via lifestyle or metformin only within the last 6 months
  • HbA1c 6.0 - 10%
  • Able to meet the time and physical demands encompassed within the exercise training intervention

You may not qualify if:

  • Contraindications to magnetic resonance procedures
  • Contraindications to exercise training
  • Participating in regular purposeful exercise training of vigorous intensity - frequency greater than or equal to 3 sessions per week and intensity greater than or equal to 6.0 metabolic equivalents (METs)
  • Weight instability or planned/ on-going dietary intervention
  • Unable to communicate sufficiently in English
  • Co-morbidity that the research team determine to be a contraindication to involvement
  • Current smoker
  • Uncontrolled hypertension - systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg
  • Additional criteria for participants with T2DM/prediabetes:
  • Taking additional oral anti-diabetic medications to metformin e.g. SGLT2i, GLP-1RA, DPP4 inhibitors, TZDs within the last 6 months
  • Taking insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospitals of Leicester Nhs Trust

Leicester, East Midlands, LE1 5WW, United Kingdom

Location

NIHR Clinical Research Network

Leicester, East Midlands, United Kingdom

Location

Sir Peter Mansfield Imaging Centre

Nottingham, East Midlands, NG7 2RD, United Kingdom

Location

Nottingham University Hospitals Nhs Trust

Nottingham, East Midlands, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver DiseaseObesityInsulin ResistanceLiver DiseasesFatty LiverDiabetes MellitusGlucose Metabolism DisordersGlucose IntoleranceMetabolic DiseasesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesEndocrine System DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismHyperglycemiaBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • James A King, PhD

    Loughborough University

    PRINCIPAL INVESTIGATOR

  • Guruprasad P Aithal, PhD

    Nottingham Biomedical Research Centre

    PRINCIPAL INVESTIGATOR

  • David Webb, PhD

    Leicester Diabetes Research Centre

    PRINCIPAL INVESTIGATOR

  • Penny Gowland, PhD

    Sir Peter Mansfield Imaging Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised control trial. Participants are randomised to an exercise group (treatment) or a control group (usual care/no treatment) for 6 weeks. Assessments occur at baseline and after 6 weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

August 7, 2018

First Posted

July 2, 2019

Study Start

October 30, 2018

Primary Completion

July 20, 2022

Study Completion

July 20, 2022

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)