E11 R73
Conditions
Interventions
Group 1: Prediabetes/Diabetes mellitus Type 2 without drug treatment - neuropsychological tests, ambulatory assessment including a working memory task
Group 2: "Healthy" individuals (without previous
Sponsors
Universitätsklinikum Frankfurt Klinik für Psychiatrie, Psychosomatik und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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 OR o Fasting plasma glucose: 5.6 – 6.9 mmol/l (100-125 mg/dL) (IFG) twice OR 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 OR o Fasting plasma glucose: = 7.0 mmol/l (= 126 mg/dL) twice OR o 2-h plasma glucose: = 11.1 mmol/l (= 200 mg/dL) - Consent - 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 - Consent
Exclusion criteria
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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition - Baseline: Cognitive Test Battery (MMSE, RCFT, Phonemic (words with 'S') and Semantic (animals) Fluency, Digit-Span, Letter-Number-Span, block-Span, TMT-A/TMT-B) - Ambulatory Assessment: Working Memory (Numeric Working Memory Task) - Follow-up (after 1 year): Cognitive Test Battery (MMSE, Phonemic (words with 'S') and Semantic (animals) Fluency, Digit-Span, Letter-Number-Span, block-Span, TMT-A/TMT-B) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Microbiome: Baseline and Follow-up after 1 year - Immunparameters: Baseline and Follow-up after 1 year | — |
Countries
Germany
Contacts
Public ContactJudith Gruber
Universitätsklinikum Frankfurt Klinik für Psychiatrie, Psychosomatik und Psychotherapie
Outcome results
None listed