The effect of nutrition and physical activity on cognition in adults with prediabetes and type 2 diabetes

• Conditions: E11; R73; Type 2 diabetes mellitus; Elevated blood glucose level

• Registration Number: DRKS00022774
• Lead Sponsor: niversitätsklinikum Frankfurt Klinik für Psychiatrie, Psychosomatik und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-08
• Study Completion: 2024-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 124

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognition<br><br>- 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)<br>- Ambulatory Assessment: Working Memory (Numeric Working Memory Task)<br>- 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 Outcome Measures

Name	Time	Method
- Microbiome: Baseline and Follow-up after 1 year<br>- Immunparameters: Baseline and Follow-up after 1 year