The Effects of Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- change of 2h glucose levels
研究概览
简要总结
In a previous study investigating the effects of intermittent fasting, our research group found evidence for higher glucose excursions and a reduced insulin response after a 36 hour fasting period as compared to an overnight fasting period in healthy subjects.
The aim of this research project is to investigate the effect of short and midterm fasting (12 hours versus 36 hours) on glucose metabolism, glucose regulatory hormones, insulin secretion and resting energy expenditure in healthy and obese people as well as in patients with type 2 diabetes.
详细描述
In this clinical study, we want to examine the effects of different fasting periods (12 hours versus 36 hours) on blood sugar levels and other metabolic parameters and hormones. For this the following investigations are carried out:
- Oral glucose tolerance test with detailed laboratory evaluation
- Bio-impedance measurement to determine body composition (muscle and fat mass)
The examinations are carried out on 4 different cohorts (normal healthy persons, obese patients, patients with type 2 diabetes and patients with type 1 diabetes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender: Both, male and female Minimum Age: 18 years
- •Inclusion Criteria Cohort I (Healthy, non-obese subjects) Age >18 years; body mass index in the range of 20.0-27.0 kg/m2; fasting plasma glucose <110mg/dL
- •Inclusion criteria cohort II (Obese subjects) Age >18 years; body mass index >30 kg/m2; fasting plasma glucose <110mg/dL
- •Inclusion Criteria Cohort III (Cohort with subjects with Type 2 Diabetes Mellitus) Age >18 years; established Diabetes mellitus type 2 on either diet or a monotherapy or combination of metformin, Dipeptidylpeptidase (DPP)-4-inhibitors or sulfonylurea
- •Inclusion Criteria Cohort IV (Cohort with subjects with Type 1 Diabetes Mellitus) Age >18 years; diagnosed with Type 1 Diabetes Mellitus >12 months; treated with multiple daily Insulin injectioins (MDII) or continuous subcutaneous Insulin Infusion (CSII); stable Insulin therapy as clinically assessed by the study physician; C-Peptide negative defined as 0.3 nmol/L; HbA1c <9.5%; no diabetic ketoacidosis within the last 12 months; no severe hypoglycaemia requiring external assistance within the last 12 months; running on the FreeStyle Libre 1 (Abbott, USA) intermittently-viewed continuous Glucose Monitoring System (iCGM) as Standard of care for Glucose monitoring
排除标准
- •(for all participants) History of cardiovascular disease; acute or chronic inflammatory disorder; heavy drinking (more than 15 drinks/week); dietary restrictions (e.g. vegetarianism and vegan); insulin Treatment (excluded subjects with Type 1 Diabetes Mellitus); corticosteroid therapy; known malignancy; women who are pregnant, breast-feeding or trying to become pregnant; history of any chronic disease process that could interfere with interpretation of study results; therapy with antidepressants within past 6 months
结局指标
主要结局
change of 2h glucose levels
时间窗: after 12 and 36 hours of fasting
Difference in the change of 2h glucose levels in an oral glucose tolerance test
次要结局
- changes in insulin sensitivity (Matsuda Index)(after 12 and 36 hours of fasting)
- Changes in body composition(after 12 and 36 hours of fasting)
- changes in insulin sensitivity (QUICKI)(after 12 and 36 hours of fasting)
- changes in insulin sensitivity (ISI)(after 12 and 36 hours of fasting)
- changes in insulin sensitivity (HOMA-Index)(after 12 and 36 hours of fasting)
- Changes in glycaemic pattern(after 12 and 36 hours of fasting)