Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- A change from baseline in HbA1c
研究概览
简要总结
To evaluate the therapeutic efficacy and metabolic impact of a low energy diet (LED) in people with familial partial lipodystrophy and diabetes. Participants will be provided with a LED (total diet replacement) for 12 weeks, before the introduction of a stepped food transition. Metabolic effects will continue to be assessed for 1 year. In order to better understand why this intervention changes insulin sensitivity, we will also collect adipose and muscle tissue samples at baseline and 12 weeks into the intervention in participants willing to have these procedures performed. These samples will be used for histological, metabolite, gene expression and protein expression analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Familial Partial Lipodystrophy
- •Age >= 18 yrs
- •Willingness to check daily blood sugars
- •HbA1c between 53mmol(7%)- 108 mmol(12%)
- •Weight stable for 3 months
- •Capacity to consent
排除标准
- •Pregnancy
- •Untreated thyroid dysfunction (patients who have been euthyroid on medication for at least 3 months can be included)
- •Use of medication adversely that affects diabetes control (e.g. steroids/ immunosuppressants/ certain antipsychotics)
- •Incapacity to give informed consent
- •History of an eating disorder/ purging behaviour
- •Previous gastric bypass/ banding
- •Use of Leptin Therapy
- •Untreated retinopathy
结局指标
主要结局
A change from baseline in HbA1c
时间窗: 12 weeks
mmol/mol
次要结局
- A change from baseline in HbA1c(1 year)
- A change from baseline in fasting glucose(12 weeks, 1 year)
- A change from baseline in liver fat(12 weeks, 1 year)
- A change from baseline in quality of life scores(12 weeks, 1 year)
- A change from baseline in depression scores(12 weeks, 1 year)
- The Three Factor Eating Questionnaire(12 weeks, 1 year)
- A change from baseline in triglycerides(12 weeks, 1 year)
- A change from baseline in insulin sensitivity(12 weeks, 1 year)
- A change from baseline in antidiabetic medication use(12 weeks, 1 year)
- A change from baseline in anxiety scores(12 weeks, 1 year)
- Adult Eating Behaviour Questionnaire(12 weeks, 1 year)
- A change from baseline in pancreatic fat(12 weeks, 1 year)
研究者
Mandour Omer Mandour
Wellcome Trust Senior Clinical Fellow
Cambridge University Hospitals NHS Foundation Trust