The GlasVEGAS Study (Glasgow Visceral & Ectopic Fat With Weight Gain in South AsianS)
Condition: Diabetes; Weight Gain; Weight Loss; Cardiovascular Disease; Obesity
MeSH terms: Cardiovascular Diseases; Body Weight; Weight Loss; Weight Gain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      In addition, the knowledge gained from participation may benefit people who are at risk of
      diabetes in the future by increasing our understanding of why South Asians are at increased
      risk of developing diabetes. It will also help guide future research investigating how to
      reduce this increased risk through lifestyle changes and may also help direct the development
      of medicines to prevent and treat diabetes groups at increased risk of the disease.

      Possible disadvantages of the study are gaining 7% of body weight over 4-6 weeks. This is
      likely to temporarily induce negative metabolic changes. However, investigators are also
      supporting losing this weight (and hopefully more) in the weight loss phase of the study.
      There is no evidence that short-term weight gain of this nature causes any long-term adverse
      effects. Longer-term weight gain however is associated with an increased risk of diabetes,
      cardiovascular disease and high blood pressure. It is therefore important that investigators
      ensure participants return to original weight at the start of the study. Taking fat biopsies
      carries a small risk of minor bruising or an infection. Good sterile practice reduces this
      risk of infection and application of ice and pressure to the biopsy site reduces the risk of
      bruising. Blood sampling via the cannula may cause minor bruising or an inflammation of the
      vein. Some participants may feel faint when they give blood. One of the exercise tests will
      be at a maximal level and the possibility exists that, very occasionally, certain changes may
      occur during or shortly after the test. They include abnormal blood pressure, fainting or a
      change in the normal rhythm of the heartbeat. There is a small possibility that taking part
      in this study will reveal a health problem that patients already have such as high
      cholesterol or high blood pressure. If such a problem is revealed, investigators will ask
      permission to inform the participant's General Practitioner to receive clinically appropriate
      follow-up care.

      This study is running for ~2.5 years from March 2015 and is based at the University of
      Glasgow. The study is being funded by the European Commission as part of the European Medical
      Information Framework (EMIF), called EMIF-Metabolic. This research will help investigators to
      better predict who is likely to be at risk of developing diseases such as diabetes and to
      develop new medicines to prevent and treat these diseases. More details about EMIF-Metabolic
      are available here: http://www.emif.eu/emif-meta/objectives.
    

Intervention name(s): Weight gain; Weight loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weight gain of 7% body weight over 4-6 weeks by ingesting an extra 1500-2000 kcal/day; Weight loss of 7-15% body weight over 12 weeks by increased exercise and either an alternate day fasting dietary regime or a weight watchers dietary regime
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: diabetes; metabolism; cardiovascular disease; weight gain; weight loss; european; south asian; obesity