Obesity Clinical Trials in United Kingdom

In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to achieve normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. The investigators hope over time this will improve the knowledge of clinicians about treating obesity with endoscopy and support future access and funding to these treatments. Read Less

The aim of this randomised control trial is to investigate the role of fasted exercise on cardiometabolic health. Participants will be assigned to one of three conditions, fasted exercise, fed exercise and control (no exercise). Participants in the exercise groups will complete four weeks of moderate intensity cycling exercise, three times per week, either in the fasted or fed state according to their group assignment. Experimental trials involving anthropometric and cardiometabolic disease risk factor measurements as well as metabolic responses to a subsequent meal ingestion following exercise will be compared pre-intervention and post intervention. Read Less

NT-proBNP does not adequately identify HF(pEF) in people with suspected HF at low levels, particularly in patients with obesity. This study will investigate: 1. alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity 2. novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity. 3. novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \<125 ng/L 4. the prevalence of HF in people with suspected HF and low NT-proBNP \<125 ng/L) Read Less

This study aims to examine if partial sleep deprivation results in alterations blood markers and subjective markers of homeostatic, and hedonic appetite, as well as provide initial data as to the impact of sleep restriction on gastric emptying. Read Less

Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes. Read Less

Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored to the challenges of living with a LTC and therefore provide the most appropriate support for these patients. Such a measure would also be useful in research to identify the presence of illness-related distress in different patient groups. This project will therefore create a new measure of illness-related distress that has applications for both research and clinical practice. This will involve the psychometric validation of the new illness-related distress measure to test how valid and reliable the measure is. The aim of the project is to provide initial validation of the Illness Related Distress Scale in a community sample, recruited through online platforms. The objective of the study is to gather initial validity and reliability data for the scale. Read Less

To assess the safety, acceptability and feasibility of testing Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) programmes for 12 weeks in a real life setting with people with T1D and obesity. Read Less

A study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (T2DM) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery. Read Less

The obesity epidemic is growing worldwide and in the UK this is perpetuated with a third of women classified as overweight/obese in 2020. Many of these woman are of childbearing age and go on to have high risk pregnancies which are often complicated by gestational or pre-existing (type 2 diabetes mellitus (GDM, T2DM). Bariatric surgery is the most successful treatment of sustainable weight loss and is associated with a reduction in rates of GDM, pre-eclampsia, delivery of large babies but increased risk of delivery of small babies and preterm delivery. The aims of the study are to investigate the maternal and fetal/neonatal, biophysical and biochemical, intra-uterine environment and postnatal profile of pregnancies: 1. affected by maternal obesity and/or GDM/T2DM compared to pregnancies with normal maternal body mass index (BMI). 2. with previous maternal bariatric surgery compared to pregnancies without previous bariatric surgery but matched for maternal pre-surgery and early pregnancy BMI. Read Less

The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and/or from NAFL through NASH to fibrosis and cirrhosis. Read Less

The purpose of this study is to assess whether the changes in gut hormones seen following Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen post-operatively. Read Less

Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver disease is now the 3rd leading cause of premature death in the United Kingdom. The majority of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes, injecting drug use) and therefore reversible if caught at a precirrhosis stage. However, current liver function blood tests are poor inadequate, and subsequently a large burden of liver disease is currently missed. A variety of noninvasive liver biomarkers (blood and imaging tests) have been developed which identify liver disease accurately at earlier stages of scarring. The identification of liver disease in the community, where previous studies have discovered a large burden of previously unidentified but significant liver disease, is therefore a feasible place to develop new liver disease investigation pathways using these noninvasive markers. In collaboration with the Department of Health, Nottingham University Hospitals have commenced a pilot community liver disease pathway in two General Practices in Nottingham in February 2012. Patients with liver risk factors (hazardous alcohol use, obesity or type 2 diabetes)are invited to take part in the pathway. Patients undergo a simple blood test (AST:ALT ratio and BARD score), with a high test result requiring referral for a liver stiffness scan (Fibroscan)which is performed in the community setting. High threshold scan values are reviewed by a consultant liver specialist in a community liver clinic. Preliminary findings show that the pathway accurately identifies patients with early liver scarring and previously unidentified significant liver disease. The participating General Practitioners have also noted a striking number of patients finally engaging in important lifestyle changes following pathway implementation. A second phase of the pilot pathway, in 2 Inner City General Practices with a total practice population of c.14,000 patients commenced in June 2013. We have subsequently designed this cohort study, where pilot participants will be consented for follow up over a long period. We will assess future liver-related and cardiovascular events (including death), and perform qualitative patient interviews to assess the reasons for and persistence of lifestyle changes after liver disease investigation. We hypothesize that stratification of liver disease in the community will unearth a significant amount of previously undetected but significant chronic liver disease. Moreover, we will evaluate whether stratification of liver disease using these tests predicts future liver and cardiovascular disease and death, and whether stratification has an impact on patient's future lifestyle choices. Read Less