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Diabetes, Exercise and Liver Fat (DELIVER) ((DELIVER))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004273
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborators:
University Hospitals, Leicester
Nottingham University Hospitals NHS Trust
University of Nottingham
Information provided by (Responsible Party):
James King, Loughborough University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Non-Alcoholic Fatty Liver Disease Obesity Insulin Resistance Liver Diseases Fatty Liver Diabetes Mellitus Glucose Metabolism Disorders Glucose Intolerance Metabolic Disease Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Type 2 Diabetes and Exercise on Liver Fat Quality
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020


Arm Intervention/treatment
Experimental: Exercise
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, three exercise training sessions will be supervised by the research team (visits three to 20), whilst one session will be unsupervised but monitored objectively using a heart rate monitor.
Behavioral: Exercise
24 moderate-intensity exercise training sessions over six weeks (four times per week; ~50 min per session)

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



Primary Outcome Measures :
  1. Change in liver saturated lipid index (%) determined by proton magnetic resonance spectroscopy (1H-MRS) using a 3T MRI scanner [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention


Secondary Outcome Measures :
  1. Change in Liver unsaturated lipid index (%) - measured using 1H-MRS [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention

  2. Change in Liver polyunsaturated lipid index (%) - measured using 1H-MRS [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention

  3. Change in total hepatic lipid composition (%) - measured using 1H-MRS [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention

  4. Change in liver inflammation - measured using magnetic resonance imaging (MRI) with a 3T Philips Ingenia MRI scanner [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention

  5. Change in visceral adipose tissue - measured using magnetic resonance imaging (MRI) with a 3T Philips Ingenia MRI scanner [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention

  6. Change in subcutaneous abdominal adipose tissue - measured using magnetic resonance imaging (MRI) with a 3T Philips Ingenia MRI scanner [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention

  7. Change in body mass [ Time Frame: 2 measurements: Baseline, week 6 ]
    Body mass determined with scales. Response to a six week exercise training intervention

  8. Change in body fat percentage [ Time Frame: 2 measurements: Baseline, week 6 ]
    Body fat percentage determined via bio-electrical impedance. Response to a six week exercise training intervention

  9. Change in aerobic fitness (peak oxygen uptake) [ Time Frame: 2 measurements: Baseline, week 6 ]
    Treadmill based aerobic fitness test. Response to a six week exercise training intervention

  10. Change in liver enzymes [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention. Measured in fasted venous plasma samples using enzymatic, colorimetric methods using a semi-automatic, bench-top analyser.

  11. Change in glucose [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention. Measured in fasted venous plasma samples using enzymatic, colorimetric methods using a semi-automatic, bench-top analyser.

  12. Change in insulin [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention. Measured in fasted venous plasma samples using a commercially available enzyme-linked immunosorbent assay (ELISA).

  13. Change in lipids [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention. Measured in fasted venous plasma samples using enzymatic, colorimetric methods using a semi-automatic, bench-top analyser.

  14. Change in HbA1c [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention. Measured in fasted venous plasma samples using enzymatic, colorimetric methods using a semi-automatic, bench-top analyser.

  15. Change in homeostasis model assessment of insulin resistance (HOMA-IR; surrogate marker of hepatic insulin resistance) [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention. HOMA-IR will be calculated using fasted concentrations of plasma glucose and insulin.

  16. Change in adipose tissue insulin resistance (ADIPO-IR; surrogate marker of adipose tissue insulin resistance) [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention. ADIPO-IR will be calculated using fasted concentrations of plasma insulin and non-esterified fatty acids.

  17. Change in circulating Inflammatory proteins [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention. Measured in fasted venous plasma samples using a commercially available enzyme-linked immunosorbent assay (ELISA) and enzymatic, colorimetric methods using a semi-automatic, bench-top analyser.

  18. Change in Hepatokines [ Time Frame: 2 measurements: Baseline, week 6 ]
    Response to a six week exercise training intervention. Measured in fasted venous plasma samples using a commercially available enzyme-linked immunosorbent assay (ELISA).

  19. Change in objectively measured sedentary time - GENEactiv physical activity monitor [ Time Frame: 2 measurements: Baseline, week 6 ]
    monitor worn for 7 days on the wrist for 24 hrs

  20. Change in objectively measured physical activity - GENEactiv physical activity monitor [ Time Frame: 2 measurements: Baseline, week 6 ]
    monitor worn for 7 days on the wrist for 24 hrs

  21. Change in energy intake [ Time Frame: 2 measurements: Baseline, week 6 ]
    food diary - two weekdays and one weekend day. Response to a six week exercise training intervention

  22. Change in macronutrient intake [ Time Frame: 2 measurements: Baseline, week 6 ]
    food diary - two weekdays and one weekend day. Response to a six week exercise training intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Inactive (low or medium score on IPAQ-Short Form)
  • 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
  • HbA1c > 6%
  • Diagnosed T2DM
  • Treatment via lifestyle or metformin only within the last 6 months
  • HbA1c 6.5 - 10%
  • Able to meet the time and physical demands encompassed within the exercise training intervention

Exclusion Criteria:

  • Contraindications to magnetic resonance procedures
  • Contraindications to exercise training
  • Excessively active
  • 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
  • Taking additional oral anti-diabetic medications to metformin e.g. SGLT2i, GLP-1RA, DPP4 inhibitors, TZDs within the last 6 months
  • Taking insulin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004273


Contacts
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Contact: James A King, PhD +44 1509 228457 J.A.King@lboro.ac.uk
Contact: Aron P Sherry, PhD +44 1509 228462 a.p.sherry@lboro.ac.uk

Locations
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United Kingdom
University Hospitals of Leicester Nhs Trust Active, not recruiting
Leicester, East Midlands, United Kingdom, LE1 5WW
NIHR Clinical Research Network Recruiting
Leicester, East Midlands, United Kingdom
Contact: Lisa Wann       lisa.wann@uhl-tr.nhs.uk   
Sir Peter Mansfield Imaging Centre Active, not recruiting
Nottingham, East Midlands, United Kingdom, NG7 2RD
Nottingham University Hospitals Nhs Trust Active, not recruiting
Nottingham, East Midlands, United Kingdom, NG7 2UH
Sponsors and Collaborators
James King
University Hospitals, Leicester
Nottingham University Hospitals NHS Trust
University of Nottingham
Investigators
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Principal Investigator: James A King, PhD Loughborough University
Principal Investigator: Guruprasads 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
  Study Documents (Full-Text)

Documents provided by James King, Loughborough University:
Study Protocol  [PDF] November 14, 2018
Statistical Analysis Plan  [PDF] August 6, 2018

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Responsible Party: James King, Chief Investigator, Loughborough University
ClinicalTrials.gov Identifier: NCT04004273    
Other Study ID Numbers: 241046
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James King, Loughborough University:
Type 2 diabetes
Non-alcohol fatty liver disease
Exercise
Saturated fat
MRI
Proton magnetic resonance spectroscopy
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Metabolic Diseases
Glucose Metabolism Disorders
Glucose Intolerance
Endocrine System Diseases
Digestive System Diseases
Hyperinsulinism
Hyperglycemia