Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Insulin sensitivity
研究概览
简要总结
Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The investigators hypothesize that a lower carbohydrate content in the diabetic diet than the recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic factors like incretin hormones and decrease their insulinotropic effects due to their glucose dependency. This will reduce postprandial insulin concentration, resulting in an improved insulin sensitivity and glucose metabolism. This clinical study will examine in diabetic, prediabetic and healthy subjects the acute effects of short term highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to insulin action, pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in plasma and novel measures of fatty acid metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Men age 18-70 years
- •Postmenopausal women age 55-70 years
- •Non-smoker (abstinent at least 6 months)
- •HbA1c < 74 mmol/mol
- •Fasting blood glucose < 11 mmol/L (mean of 3 measurements)
- •Negative (<25 IU/L) plasma glutamate decarboxylase (GAD-65) antibodies (IgG)
- •Hemoglobin > 7.5 mmol/L (men); > 6.8 mmol/L (women)
- •Normal thrombocytes (140-400 x 109/L)
- •eGFR > 45 ml/min per 1.73 m2
- •Alkaline phosphatase < 140 IU/L
- •Alanine aminotransferase < 70 IU/L
- •Normal International Normalized Ratio (0.9-1.2)
排除标准
- •Critical illness
- •Anti-diabetic drugs other than metformin (maximum of 2000 mg / day)
- •Steroid treatment e.g. prednisolone
- •Reported or journalized severe food allergy or intolerance
- •Reported or journalized gut disease e.g. Crohn's disease, Coeliac disease
- •Reported or journalized alcohol dependence syndrome
研究组 & 干预措施
Type 2 diabetic subjects
干预措施: Low carbohydrate meals (Other)
Type 2 diabetic subjects
干预措施: Standard carbohydrate meals (Other)
Prediabetic subjects
干预措施: Low carbohydrate meals (Other)
Prediabetic subjects
干预措施: Standard carbohydrate meals (Other)
Healthy subjects
干预措施: Low carbohydrate meals (Other)
Healthy subjects
干预措施: Standard carbohydrate meals (Other)
结局指标
主要结局
Insulin sensitivity
时间窗: Measured during meal tests (2 days with each intervention)
Insulin sensitivity as measured by the oral minimal model applied to the meal test
次要结局
未报告次要终点
研究者
Amirsalar Samkani
MD, PhD-stud
Bispebjerg Hospital