Obesity Clinical Trial
— (DELIVER)Official title:
The Impact of Type 2 Diabetes and Exercise on Liver Fat Quality
NCT number | NCT04004273 |
Other study ID # | 241046 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 30, 2018 |
Est. completion date | July 20, 2022 |
Verified date | October 2022 |
Source | Loughborough University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 20, 2022 |
Est. primary completion date | July 20, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 30 Years to 75 Years |
Eligibility | 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) - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NIHR Clinical Research Network | Leicester | East Midlands |
United Kingdom | University Hospitals of Leicester Nhs Trust | Leicester | East Midlands |
United Kingdom | Nottingham University Hospitals Nhs Trust | Nottingham | East Midlands |
United Kingdom | Sir Peter Mansfield Imaging Centre | Nottingham | East Midlands |
Lead Sponsor | Collaborator |
---|---|
James King | Nottingham University Hospitals NHS Trust, University Hospitals, Leicester, University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in Liver unsaturated lipid index (%) - measured using 1H-MRS | Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 | |
Secondary | Change in Liver polyunsaturated lipid index (%) - measured using 1H-MRS | Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 | |
Secondary | Change in total hepatic lipid composition (%) - measured using 1H-MRS | Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 | |
Secondary | Change in visceral adipose tissue - measured using magnetic resonance imaging (MRI) with a 3T Philips Ingenia MRI scanner | Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 | |
Secondary | Change in subcutaneous abdominal adipose tissue - measured using magnetic resonance imaging (MRI) with a 3T Philips Ingenia MRI scanner | Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 | |
Secondary | Change in body mass | Body mass determined with scales. Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 | |
Secondary | Change in body fat percentage | Body fat percentage determined via bio-electrical impedance. Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 | |
Secondary | Change in aerobic fitness (peak oxygen uptake) | Treadmill based aerobic fitness test. Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 | |
Secondary | Change in liver enzymes | 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. | 2 measurements: Baseline, week 6 | |
Secondary | Change in glucose | 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. | 2 measurements: Baseline, week 6 | |
Secondary | Change in insulin | Response to a six week exercise training intervention. Measured in fasted venous plasma samples using a commercially available enzyme-linked immunosorbent assay (ELISA). | 2 measurements: Baseline, week 6 | |
Secondary | Change in lipids | 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. | 2 measurements: Baseline, week 6 | |
Secondary | Change in HbA1c | 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. | 2 measurements: Baseline, week 6 | |
Secondary | Change in homeostasis model assessment of insulin resistance (HOMA-IR; surrogate marker of hepatic insulin resistance) | Response to a six week exercise training intervention. HOMA-IR will be calculated using fasted concentrations of plasma glucose and insulin. | 2 measurements: Baseline, week 6 | |
Secondary | Change in adipose tissue insulin resistance (ADIPO-IR; surrogate marker of adipose tissue insulin resistance) | Response to a six week exercise training intervention. ADIPO-IR will be calculated using fasted concentrations of plasma insulin and non-esterified fatty acids. | 2 measurements: Baseline, week 6 | |
Secondary | Change in circulating Inflammatory proteins | 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. | 2 measurements: Baseline, week 6 | |
Secondary | Change in Hepatokines | Response to a six week exercise training intervention. Measured in fasted venous plasma samples using a commercially available enzyme-linked immunosorbent assay (ELISA). | 2 measurements: Baseline, week 6 | |
Secondary | Change in objectively measured sedentary time - GENEactiv physical activity monitor | monitor worn for 7 days on the wrist for 24 hrs | 2 measurements: Baseline, week 6 | |
Secondary | Change in objectively measured physical activity - GENEactiv physical activity monitor | monitor worn for 7 days on the wrist for 24 hrs | 2 measurements: Baseline, week 6 | |
Secondary | Change in energy intake | food diary - two weekdays and one weekend day. Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 | |
Secondary | Change in macronutrient intake | food diary - two weekdays and one weekend day. Response to a six week exercise training intervention | 2 measurements: Baseline, week 6 |
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