Comparison of Postpradial Gut Hormone and Metabolic Responses Between Patients With Type 1 Diabetes Mellitus and Healthy Controls
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Gut peptide hormone responses
研究概览
简要总结
The study will compare the postprandial responses to a test meal between subjects with type 1 diabetes and healthy control subjects, in terms of gut hormone levels, meal induced thermogenesis, hunger and satiety perception, as well as futher metabolic parameters.
详细描述
Aim of the study
To compare the acute effect of the consumption of a test meal on satiety, gastrointestinal hormones' response, post-meal thermogenesis, and further metabolic parameters in lean patients with type 1 diabetes mellitus (T1DM), obese patients with T1DM, and healthy lean and obese controls.
Study subjects:
Four groups of participants will be recruited, consisting of 15 lean healthy subjects (BMI <25 kg/m2), 15 obese healthy subjects, 15 lean patients with T1DM (BMI <25 kg/m2), and 15 obese patients with T1DM (BMI ≥ 30kg/m2). Groups will be matched for age and sex. Healthy volunteers will be recruited from the community, and diabetic individuals from our diabetes clinic. Eligibility criteria will include 18-65 years of age, no use of medications affecting appetite and stable weight (no fluctuations exceeding 5 kg the last 3 months.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 diabetes
- •BMI >30 kg/m2 for the obese groups
排除标准
- •Diabetic neuropathy
- •Malignancy
结局指标
主要结局
Gut peptide hormone responses
时间窗: 3 hours
Postprandial responses of ghrelin, PYY, GLP-1, Glicentin, Oxyntomodulin measured as area under the curve (AUC)
次要结局
- Meal induced thermogenesis(3 hours)
研究者
Alexandros Kokkinos
Associate Professor in Internal Medicine
National and Kapodistrian University of Athens