Cortical Plasticity in Type II Diabetes Mellitus

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

General inclusion criteria:
• No evidence of dementia (normal Mini Mental Status exam; (MMSE score >=28)
• Minimum completed 8th grade education
• Age range 30-70 years
• BMI: 27-35 kg/m²
• Right hand dominance;Inclusion criteria for DM2 patients
• Clinical diagnosis of a type II diabetes mellitus at least one year before the start of the study
• Oral glucose lowering medication;Inclusion criteria for impaired fasting glucose (IFG) participants
• No history of DM
• Fasting plasma glucose level: >= 5.55 mmol/L and <= 6.99 mmol/L;Inclusion criteria for healthy control participants
• No history of DM
• Normal fasting glucose level: >= 3.88 mmol/L and <= 5.54 mmol/L

Exclusion Criteria

• Clinical evidence or suspicion of significant macrovascular disease or complications of DM2, including cardiovascular disease (controlled hypertension is acceptable), peripheral vascular disease (e.g. status post amputation) or large vessel stroke
• Uncontrolled arterial hypertension (defined as blood pressure > 160/100 mmHg despite antihypertensive treatment)
• Clinical evidence or suspicion of significant microvascular disease or complications of DM2, including vision impairing retinopathy, vascular dementia or severe neuropathy
• Renal insufficiency (estimated glomerular filtration rate, eGFR, <30 mL/min)
• Current or past history of any progressive neurological disorder or serious neurological disorder affecting cognitive function, including dementia, stroke, brain lesions, or multiple sclerosis; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment
• Past or current history of major depression, bipolar disorder or psychotic disorders, or any other major psychiatric condition
• History of fainting spells of unknown or undetermined etiology that might constitute seizures
• History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
• Any uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• Insulin dependent diabetic patients
• Substance abuse or dependence within the past six months
• Pregnancy
• Known metal in the head (such as a surgical aneurysm clip) or a history of prior neurosurgical procedures
• Ferromagnetic bio-implants activated by any electronic, mechanical or magnetic means, such as cochlear implants, pacemakers, medication pumps, vagal stimulators, deep brain stimulators, neurostimulators, biostimulators, or ventriculo-peritoneal shunts
• Use of tobacco, including cigarettes, smokeless tobacco, cigars, and pipes

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Comparison of TMS-based measures of cortical reactivity and plasticity in<br /><br>patients with impaired fasting glucose (IFG) and type II diabetes mellitus<br /><br>(DM2) versus healthy controls (HC):<br /><br><br /><br>• TMS-based measures of cortical reactivity and plasticity in participants with<br /><br>IFG, patients with DM2, and in healthy controls.<br /><br>• Comparison of iTBS measures of plasticity with HOMA scores.<br /><br>• Comparison of iTBS measures of plasticity with fasting glucose levels</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The impact of APOE (Apoliprotein E) and BDNF (Brain Derived Neurotrophic<br /><br>Factor) polymorphisms on the measures of reactivity and plasticity.<br /><br>• The determination whether levels of tau influence the TMS measures of<br /><br>reactivity and plasticity.</p><br>