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Beside well described peripheral effects, insulin can also affect the human central nervous system. Centrally acting insulin seems to have an influence e.g. on whole-body metabolism and food intake. Targeting insulin receptors in the central nervous system can modulate peripheral insulin sensitivity as well as pancreatic insulin secretion. In humans, the effect of insulin can be measured in different brain areas as estimate of central nervous insulin sensitivity. Reduced central nervous insulin sensitivity, called "central insulin resistance," has been associated, for example, with obesity, unfavorable body fat distribution, and impaired cognitive functionality. Recently novel subtypes and risk clusters of diabetes and prediabetes have been identified. In this study the investigators want to investigate and compare central nervous insulin sensitivity as well as cognitive function in the different diabetes and prediabetes risk clusters.
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Inclusion criteria
manifest diabetes mellitus type 2 with initial diagnosis ≤ 10 years ago, defined as
or a currently existing increased risk of developing type 2 diabetes, defined as
prediabetes, defined as
and/or at least one of the following factors indicating an increased risk for developing type 2 diabetes mellitus:
or no manifest diabetes mellitus type 2 and no currently existing increased risk for developing type 2 diabetes (control group: BMI 18.5 to 24.5 kg/m2)
female and male (1:1), voluntary adults
at least 18 years old and able to give consent
understanding of study explanations and instructions
consent to information in case of unexpected proven pathological findings.
Exclusion criteria
Only in subjects without manifest diabetes mellitus type 2: Taking medications that affect sugar metabolism (e.g., antidiabetic medications or glucocorticoids).
Diabetes mellitus type 1 or Latent autoimmune diabetes in the adult (GAD and/or IA2 antibodies positive)
MODY (Maturity onset Diabetes of the Young)
Decompensated diabetes mellitus type 2 (HbA1c greater than 9.6% and/or fasting blood glucose > 230 mg/dl)
BMI < 18.5 or > 45 kg/m2
Individuals wearing non-removable metal devices in or on the body such as:
there is a pregnancy or pregnancy cannot be excluded
breastfeeding women
Individuals with impaired temperature sensation and/or increased sensitivity to heating of the body.
symptomatic coronary heart disease, heart failure greater than NYHA 3, previous heart attack
Condition following stroke
Individuals with hearing disease or increased sensitivity to loud sounds
Persons with claustrophobia (fear of place)
Minors or subjects incapable of giving consent
Subjects who have had an operation less than 3 months ago
Acute illness or infection within the last 4 weeks
Severe neurological or psychiatric diseases, e.g. severe depression (at least 29 points according to BDI II), schizophrenia or bipolar disorder.
Use of centrally acting drugs
Known presence of malignant disease within the last 5 years
Diseases of the pancreas
Systemic infection (CRP > 1 mg/dl)
Following bariatric surgery
Antibiotic therapy within the last 4 weeks prior to study inclusion
No consent to be informed about incidentally discovered pathological findings
Participation in interventional trials and receipt of investigational medication in the last 30 days
Severe diabetic complications such as chronic kidney disease (KDIGO CKD greater than G4) or severe proliferative retinopathy
Subjects with hemoglobin levels Hb<10.5g/dl (for women), Hb<11.5g/dl (for men)
Other medical conditions that, in the opinion of an investigator, may jeopardize the success of the study or indicate that the subject may be at risk of harm
Allergic diseases to any of the substances used
Primary purpose
Allocation
Interventional model
Masking
180 participants in 2 patient groups, including a placebo group
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Central trial contact
Stephanie Kullmann, Prof.; Christian Kübler, Dr.
Data sourced from clinicaltrials.gov
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