Cortical Plasticity in Type II Diabetes Mellitus

Cortical Plasticity in Type II Diabetes Mellitus - plasticityDM2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44281

Enrollment

Registered

2016-06-29

Start date

2016-12-19

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult-onset diabetes mellitus non-insulin-dependent diabetes mellitus

Interventions

plasticity

theta burst stimulation

diabetes type II

non-invasive brain stimulation

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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 = 3.88 mmol/L and

Exclusion criteria

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,

Design outcomes

Primary

Measure	Time frame
Comparison of TMS-based measures of cortical reactivity and plasticity in patients with impaired fasting glucose (IFG) and type II diabetes mellitus (DM2) versus healthy controls (HC): • TMS-based measures of cortical reactivity and plasticity in participants with IFG, patients with DM2, and in healthy controls. • Comparison of iTBS measures of plasticity with HOMA scores. • Comparison of iTBS measures of plasticity with fasting glucose levels	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
• The impact of APOE (Apoliprotein E) and BDNF (Brain Derived Neurotrophic Factor) polymorphisms on the measures of reactivity and plasticity. • The determination whether levels of tau influence the TMS measures of reactivity and plasticity.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)