Establishing the Metabolic and Nutritional Requirements of Individuals with Extreme Body Morphology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Glucose incremental area under the curve during the oral glucose tolerance test
研究概览
简要总结
Researchers at the University of Bath are investigating the metabolism of individuals with extreme body size, including those with skeletal dysplasia (commonly known as dwarfism), to manage health risks such as heart disease. By better understanding how body size could change how the body processes food, or how being bigger or smaller may influence eating habits, healthy living guidelines to tackle issues such as obesity and overweight in these populations can be improved. With help from expertise in the psychology field, this research will also investigate whether the mental health of these individuals has been affected by their size. On the whole, this study will involve one 24-hour visit to a research laboratory at the University of Bath, followed by a 2-week monitoring period to capture 'normal' physical activity and eating routines.
详细描述
After signing informed consent to take part in the study, participants will be asked to complete a health entry criteria questionnaire, including a physical activity readiness questionnaire and Eating Disorder Examination Questionnaire, to confirm eligibility. Participants will also be required to complete a health questionnaire for administration of anaesthetic as part of the biopsy procedure. Individuals who are very small or very big (without skeletal dysplasia) will be asked to attend the laboratory for a pre-trial screening as an additional eligibility criterion. This will involve measuring height, body mass, and standing on a specialised scale (bioelectrical impedance scale) which estimates how much muscle and fat someone has. If it is suspected that the participant meets the stated fat-free mass criteria, a complete a full body Dual Energy X-ray Absorptiometry (DEXA) scan to assess body composition more accurately will be completed. This involves lying flat on a bed for ~7 minutes and resting whilst the scan takes place. The research team will then inform the participant after analysing the scan results if they are eligible and can continue with the study.
All participants deemed eligible who are able and willing to take part will be invited to attend the University of Bath Human Physiology Laboratory for the full trial.
On day 1, prior to attending the University of Bath participants will be asked to eat a standardised diet of a cereal breakfast, and a supermarket purchased sandwich, drink and snack meal deal for lunch, with self-selected quantities. Participants will ideally be fasted for 4-5 hours before arrival (~17:00).
Upon arrive at the University, individuals with skeletal dysplasia will also be asked to complete the health entry criteria questionnaire and physical activity readiness questionnaire to ensure eligibility. It is important that participants let the researchers know of any medical conditions or any change in circumstance since signing up. All information is strictly confidential.
The research team will first take measurements of height, body mass, waist and hip circumference, abdomen diameter (distance from your front to back), sitting height and blood pressure. Early into the visit, participants will also be briefed on collecting urine into provided containers. Individuals with skeletal dysplasia will then have a Dual Energy X-ray Absorptiometry (DEXA) scan to assess body composition. All participants will also have a Peripheral Quantitative Computed Tomography (pQCT) scan which involves placing one leg into a round scanner to assess the tissues in your leg e.g., bone, muscle and fat (as if the image were a slice). The scan requires you to keep your leg still for ~10 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 16 years or over
- •Any diagnosed form of skeletal dysplasia (i.e., extreme proportionate or disproportionate short stature)
- •Individuals without skeletal dysplasia but presenting with extreme body morphology, defined as: individuals with extreme large body morphology (males >75 kg fat-free mass and females >57.25 kg fat-free mass), or males and females with extreme small body morphology (<47.4 kg fat-free mass).
排除标准
- •Any reported condition, behaviour or reported use of substances which may pose undue personal risk to the participant or introduce bias into the study, except for any which are ubiquitous in society and so would be equally distributed between groups and/or therefore relevant to generalisation (e.g., statins, caffeine, GLP-1 agonists).
- •Females who are pregnant or lactating
- •Individuals with a diagnosed history of eating disorders (e.g., anorexia)
- •Individuals with known bleeding disorders (exclusion for biopsies only)
- •Individuals with known allergy or intolerance to lidocaine
- •Inability to read or speak English, or otherwise to consent to procedures
- •Individuals who are not weight stable (i.e., >3 kg change in body mass in past 3 months)
结局指标
主要结局
Glucose incremental area under the curve during the oral glucose tolerance test
时间窗: 3 hours
Difference in blood glucose incremental area under the curve between individuals with skeletal dysplasia, and extremely small and large body size.
次要结局
- Fasting muscle glycogen concentration(Baseline)
- Substrate oxidation during oral glucose tolerance test(3 hours)
- Insulin response to oral glucose tolerance test(3 hours)
- Glycaemic response to mixed meal tolerance test(3 hours)
- Insulin response to mixed meal tolerance test(3 hours)
- Resting metabolic rate(Baseline)
- Fasted blood glucose concentration(Baseline)
- Fasted blood insulin concentration(Baseline)
- Regulatory hormone response to oral glucose tolerance test(3 hours)
- Regulatory hormone response to mixed meal tolerance test(3 hours)
- Exogenous carbohydrate oxidation(7 hours)
- C-Peptide response to oral glucose tolerance test(3 hours)
- Substrate oxidation during mixed meal tolerance test(3 hours)
- Adipose tissue markers of insulin signalling(Baseline)
- Skeletal muscle markers of glucose metabolism(Baseline)
- C-Peptide response to mixed meal tolerance test(3 hours)
- Non-oxidative glucose disposal(7 hours)
- Continuous interstitial glucose concentration(10 days)
- Adipose tissue markers of glucose metabolism(Baseline)
- Skeletal muscle markers of insulin signalling(Baseline)
- Fasted concentration of systemic adipokines (e.g., adiponectin, resistin, leptin etc.)(Baseline)