The GlasVEGAS Study (Glasgow Visceral & Ectopic Fat With Weight Gain in South AsianS) - Does Adipose Tissue Expandibility Differ Between South Asians and Europeans and Does This Contribute to Differences in Cardio-metabolic Disease Risk?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in body metabolism after gaining 7% body weight and after losing 7% of body weight
研究概览
简要总结
South Asians have a much higher risk of diabetes compared to Europeans and investigators don't know why this is. Investigators think that South Asians' capacity to store fat safely under the skin is lower than Europeans, so they start to store fat around internal organs and in liver and muscle, and at lower body weights than Europeans. These increased levels of internal fat storage are thought to increase risk of diabetes.
The purpose of the study therefore is to investigate whether there are differences with weight gain and weight loss in fat storage, fat cell function and metabolic risk factors, in South Asians compared with Europeans. Investigators will compare South Asian and European men at the start of the study, after they have gained about 7% body weight, and again after they have lost 7-15% body weight (from peak weight) to see how gaining and losing weight affects fat storage within the body and the function of fat cells. Investigators will also assess the effect of weight gain and weight loss on metabolism, fitness and risk factors for diabetes and heart disease.
详细描述
South Asians have about five times the risk of adult onset diabetes (high blood sugar) than Europeans and nearly one in five South Asian men in the United Kingdom have the disease. Diabetes is a serious disease that can lead to a number of adverse health consequences including heart disease, kidney disease and blindness and accounts for about 10% of all healthcare costs in the UK. Obesity is strongly linked to diabetes risk, but the adverse effect of getting fatter on diabetes risk is much higher in South Asians than Europeans. The purpose of this study is to understand why this is the case. When humans put on weight initially this fat is stored under the skin (subcutaneous fat). This is relatively safe. However, when the capacity of this under skin storage is exceeded, fat is stored internally within the tummy area (visceral fat) and in organs such as the liver and muscle, which is less safe and increases diabetes risk. Investigators think that South Asians' capacity to store fat safely under the skin is lower than Europeans, so fat is stored internally and in liver and muscle at lower body weights than Europeans. The purpose of this study is to investigate whether this occurs and why. To do this investigators will compare a group of South Asian and European men and see how gaining and losing weight affects fat storage within the body and the function of fat cells. Investigators will also assess the effect of weight gain and weight loss on metabolism, fitness and risk factors for diabetes and heart disease.
The study will include healthy men of normal weight aged between 18-45 year and of either white European or South Asian (both parent of Indian, Pakistani, Bangladesh or Sri Lankan origin) ethnic origin.
Body weight will be altered by initially gaining weight and then losing weight. To do this participants will initially have to eat more food for 4-6 weeks and then go on a diet combined with exercise for 12 weeks. Participation in the study will last around 5½ months in total.
During the study pictures of body fat stores will be taken using an MRI scanner, a biopsy/sample of tummy fat will be taken to look at the fat cells and physical fitness and body metabolism (the way the body deals with sugar, insulin and fat) will be measured. These measurements will be done at three different times: before gaining weight, once weight is gained, and after losing weight (and back to original weight). The measurements will give a detailed assessment of the changes in the body when gaining or losing weight.
The benefits of taking part in the study are receiving detailed feedback about fitness levels, body fat, dietary intake, blood pressure, cholesterol, blood sugar and level of "insulin resistance". Feedback about the overall study findings will also be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants will be men of European (self-report of both parents of white European origin) or South Asian (self-report of both parents of Indian, Pakistani, Bangladeshi or Sri Lankan origin) with BMI <25 kg.m-2, who have been weight stable (± 2 kg) for >6 months.
排除标准
- •Exclusion criteria will include diabetes (physician diagnosed or HbA1c ≥6.5% on screening), history of cardiovascular disease, regular participation in vigorous physical activity, current smoking, taking drugs or supplements thought to affect carbohydrate or lipid metabolism, or other significant illness that would prevent full participation in the study.
结局指标
主要结局
Change in body metabolism after gaining 7% body weight and after losing 7% of body weight
时间窗: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Metabolic changes will be calculated by measuring levels of insulin, c-peptide, glucose, non-esterified fatty acids and NMR metabolomic responses to a standard 800 kcal meal tolerance test over 5 hours. Fasting serum adipokine levels will also be taken. Metabolic rate and substrate utilisation will be measured by indirect calorimetry using a ventilated hood.
Change in visceral adipose tissue after gaining 7% body weight and after losing 7% body weight
时间窗: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Adipose tissue will be measured by MRI scanner and the change in visceral adipose tissue quantified
Change in adipose cell insulin sensitivity after gaining 7% body weight and after losing 7% body weight
时间窗: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Adipose cells will be obtained by needle biopsy from the subcutaneous layers of adipose tissue in the abdomen. Following this adipose cells will be assessed for their sensitivity to insulin.
Change in subcutaneous adipose tissue after gaining 7% body weight and after losing 7% body weight
时间窗: Weight gain assessment made after an expected average of 5 weeks and Weight loss assessment after 12 weeks
Adipose tissue will be measured by MRI scanner and the change in subcutaneous adipose tissue quantified.
Change in liver adipose tissue after gaining 7% body weight and after losing 7% body weight
时间窗: Weight gain assessment made after an expected average of 5 weeks and Weight loss assessment after 12 weeks
Liver adipose tissue will be measured by MRI spectroscopy and the change in liver adipose tissue quantified.
Change in adipose cell morphology after gaining 7% body weight and after losing 7% body weight.
时间窗: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Adipose cells will be obtained by needle biopsy from the subcutaneous layers of adipose tissue in the abdomen. Following this adipose cells will be assessed for their morphology including size and number.
Change in adipose cell function after gaining 7% body weight and after losing 7% body weight
时间窗: Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks
Adipose cells will be obtained by needle biopsy from the subcutaneous layers of adipose tissue in the abdomen. Following this adipose cells will be assessed for their cell function including gene expression markers related to triglyceride storage and differentiation of the cells.
次要结局
- Change in fitness after gaining 7% body weight and after losing 7% of body weight(Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks)
- Change in facial appearance after gaining 7% body weight and after losing 7% of body weight(Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks)
- Change in qualitative interviews after gaining 7% body weight and after losing 7% of body weight(Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks)
- Change in physical activity after gaining 7% body weight and after losing 7% of body weight(Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks)
- Change in dietary intake after gaining 7% body weight and after losing 7% of body weight(Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks)
- Change in cognition after gaining 7% body weight and after losing 7% of body weight(Weight gain assessment made after an expected average of 5 weeks and weight loss assessment after 12 weeks)
研究者
Professor Naveed Sattar
Professor of Metabolic medicine
University of Glasgow
