The Impact of Type 2 Diabetes and Exercise on Liver Fat Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Change in liver saturated lipid index (%) determined by proton magnetic resonance spectroscopy (1H-MRS) using a 3T MRI scanner
研究概览
简要总结
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.
详细描述
Verbal eligibility check
Prior to commencing the study, participants will be contacted via telephone and an initial verbal eligibility check will take place (approx. 30 min conversation). Following this, potentially eligible participants will be invited to visit the Sir Peter Mansfield Imaging Centre for study assessment visit one.
Assessment visit 1 - Sir Peter Mansfield Imaging Centre (University of Nottingham) Informed consent Before any study related procedures can take place, the participant must sign and date the most recent approved version of the Informed Consent Form. Before consent is obtained the responsible individual will ensure that the participant fully understands all aspects of the study. It will also be clearly stated that the participant is free to withdraw from the study at any time, for any reason, without prejudice to future care, and with no obligation to give the reason for withdrawal. If a participant withdraws from the study but does not withdraw their consent, then data already obtained may be used for the study. If a participant has withdrawn due to an adverse event, a medical professional will follow up as appropriate.
The consent form will be signed and dated based up on an informed decision. The consent process will be performed by someone who has received consent training, has been authorised by the Chief Investigator, and is named on the delegation of authority log. The original signed form will be retained at the study site and copy will be given to the participant. A third copy will be posted to the participant's GP.
Questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
结局指标
主要结局
Change in liver saturated lipid index (%) determined by proton magnetic resonance spectroscopy (1H-MRS) using a 3T MRI scanner
时间窗: 2 measurements: Baseline, week 6
Response to a six week exercise training intervention
次要结局
- Change in aerobic fitness (peak oxygen uptake)(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)
- Change in body mass(2 measurements: Baseline, week 6)
- Change in body fat percentage(2 measurements: Baseline, week 6)
- Change in liver enzymes(2 measurements: Baseline, week 6)
- Change in glucose(2 measurements: Baseline, week 6)
- Change in insulin(2 measurements: Baseline, week 6)
- Change in lipids(2 measurements: Baseline, week 6)
- Change in Liver unsaturated lipid index (%) - measured using 1H-MRS(2 measurements: Baseline, week 6)
- Change in HbA1c(2 measurements: Baseline, week 6)
- Change in homeostasis model assessment of insulin resistance (HOMA-IR; surrogate marker of hepatic insulin resistance)(2 measurements: Baseline, week 6)
- Change in adipose tissue insulin resistance (ADIPO-IR; surrogate marker of adipose tissue insulin resistance)(2 measurements: Baseline, week 6)
- Change in circulating Inflammatory proteins(2 measurements: Baseline, week 6)
- Change in Hepatokines(2 measurements: Baseline, week 6)
- Change in objectively measured sedentary time - GENEactiv physical activity monitor(2 measurements: Baseline, week 6)
- Change in objectively measured physical activity - GENEactiv physical activity monitor(2 measurements: Baseline, week 6)
- Change in energy intake(2 measurements: Baseline, week 6)
- Change in macronutrient intake(2 measurements: Baseline, week 6)
研究者
James King
Chief Investigator
Loughborough University