DRKS00016148已完成未知
The Effects of prolonged Fasting on glucose metabolism and hormonal regulation in healthy, obese and subjects with type 1 and type 2 diabetes - PROLOG
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
Our data demonstrate an improved insulin sensitivity after 36 h of fasting with higher glucose variations and reduced early insulin response in non-obese people only.
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Inclusion Criteria Cohort I (Cohort with 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 (without medication)
- •Inclusion Criteria Cohort II (Cohort with obese subjects)
- •- Age >18 years
- •- Body mass index > 30.0 kg/m2
- •- Fasting plasma glucose <110mg/dL (without medication)
- •Inclusion Criteria Cohort III (Cohort with subjects with Type 2 Diabetes)
- •- Age >18 years
- •- established diabetes mellitus type 2 on either diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea
- •Inclusion Criteria Cohort IV (Cohort with Subjects with Type 1 Diabetes)
- •- Age > 18 years
- •- Diagnosed with type 1 diabetes > 12 months
- •- Treated with multiple daily insulin injections (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
- •Exclusion criteria cohort I
- •- Presence of any metabolic disease
- •- Intake of any glucose lowering, lipid lowering or blood pressure lowering medication
- •Exclusion criteria cohort II
- •- Intake of any glucose lowering medication
- •Exclusion Criteria (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)
- •- 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
研究者
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终止
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