DRKS00022774已完成不适用
The effect of nutrition and physical activity on cognition in adults with prediabetes and type 2 diabetes - PRIME
niversitätsklinikum Frankfurt Klinik für Psychiatrie, Psychosomatik und Psychotherapie0 个研究点目标入组 124 人开始时间: 2021年3月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •PreDiabetes Sample (80 participants):
- •- Age = 18 years
- •- Prediabetes or Diabetes Mellitus Type 2 (ADA, 2020)
- •Prediabetes:
- •o HbA1c: 5.7 – 6.4 % (39 - 47 mmol/mol) AND Hb: men = 11.5 mg/dl, women = 10.5 mg/dl
- •o Fasting plasma glucose: 5.6 – 6.9 mmol/l (100-125 mg/dL) (IFG) twice
- •o 2-h plasma glucose: 7.8 – 11.0 mmol/l (140 – 199 mg/dL) (IGT)
- •Diabetes mellitus Type 2:
- •o HbA1c: = 6.5 % (48 mmol/mol) AND Hb: men = 11.5 mg/dl, women = 10.5 mg/dl
- •o Fasting plasma glucose: = 7.0 mmol/l (= 126 mg/dL) twice
- •o 2-h plasma glucose: = 11.1 mmol/l (= 200 mg/dL)
- •- Participant who are of full age, have full legal capacity and are capable of providing information
- •Healthy Sample (80 participants):
- •- Healthy participants who are of full age, have full legal capacity and are capable of providing information
- •- Age = 18 years
排除标准
- •PreDiabetes Sample (80 participants):
- •- Diabetes mellitus type 1
- •- Antidiabetics (e.g. Metformin)
- •- Insulin or insulin mimics
- •- Neurological diseases
- •- Lifetime diagnosis of bipolar I disorder, schizophrenia, organic psychological disorder or substance dependence (except nicotine, cannabis)
- •- Non-correctable visual impairment
- •- Pregnancy / Nursing
- •- Alcohol and drug abuse
- •- Little knowledge of German Language
- •- Lack of ability to consent
- •- Participation in drug-associated studies in the last 6 months
- •- Glucocorticoids
- •- Weight-loss medication (within the last 3 month) or a diet
- •Healthy Sample (80 participants):
- •- Prediabetes or Diabetes mellitus type 1 & 2
- •- Neurological diseases
- •- Lifetime diagnosis of bipolar I disorder, schizophrenia, organic psychological disorder or substance dependence (except nicotine, cannabis)
- •- Non-correctable visual impairment
- •- Pregnancy / Nursing
- •- Alcohol and drug abuse
- •- Little knowledge of German Language
- •- Lack of ability to consent
- •- Participation in drug-associated studies in the last 6 months
- •- Glucocorticoids
- •- Weight-loss medication (within the last 3 month) or a diet
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