DRKS00022774
Completed
Not Applicable
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 sites124 target enrollmentMarch 8, 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- E11
- Sponsor
- niversitätsklinikum Frankfurt Klinik für Psychiatrie, Psychosomatik und Psychotherapie
- Enrollment
- 124
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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