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Clinical Trials/DRKS00022774
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.

Registry
who.int
Start Date
March 8, 2021
End Date
April 29, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
niversitätsklinikum Frankfurt Klinik für Psychiatrie, Psychosomatik und Psychotherapie

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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