Role of the central brain clock in the pathophysiology of insulin resistance

Role of the central brain clock in the pathophysiology of insulin resistance - Brain Clock and Insulin Resistance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53722

Enrollment

Registered

2022-01-31

Start date

2023-01-04

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

De perfusie/activiteit van de centrale hersenklok (SCN) Insulin resistance prediabetes

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Group 1: obese people with normal insulin sensitivity • age 25-65 years • BMI>30 • fasting plasma insulin 30 • fasting plasma insulin >62 pmol/L • fasting plasma glucose >=5.6 mmol/L • not fulfilling the ADA criteria for type 2 DM Group 3: obese subjects with overt type 2 DM • age 25-65 years • BMI>30 • diagnosis type 2 DM according to ADA criteria

Exclusion criteria

Exclusion criteria: • An extreme chronotype (midpoint of sleep on free days (MSFsc) before 2:00 or after 6:00). • Active psychiatric disorder (including circadian rhythm sleep disorder) as defined in DSM 5 • Disorders of the central nervous system (Early-onset dementia, stroke, epilepsy, Parkinson*s disease, brain tumour) • Severe visual impairment (WHO classification) • Shift workers • Crossing > 2 time zones in the 3 months before the study • Patients with type 2 DM receiving insulin treatment or GLP-1 agonists • MRI safety and contraindications o The presence of MRI-incompatible metal implants or devices: o Claustrophobia o Pregnancy o Waist circumference or shoulder circumference >155 cm o Body weight > 200 kg o Inability to walk up a staircase independently

Design outcomes

Primary

Measure	Time frame
The daily rhythm in SCN activity. The primary outcomes are mean SCN activity, the timing of the highest and lowest value of SCN activity, and the difference between the highest and lowest value of SCN activity (i.e. the amplitude) These outcomes will be assessed with: • baseline SCN perfusion using Arterial Spin Labelling (non-invasive method), • SCN functional connectivity using a seed-based analysis of resting state data • the SCN response to light using the BOLD response	—

Measure

Time frame

The daily rhythm in SCN activity. The primary outcomes are mean SCN activity, the timing of the highest and lowest value of SCN activity, and the difference between the highest and lowest value of SCN activity (i.e. the amplitude) These outcomes will be assessed with: • baseline SCN perfusion using Arterial Spin Labelling (non-invasive method), • SCN functional connectivity using a seed-based analysis of resting state data • the SCN response to light using the BOLD response

—

Secondary

Measure	Time frame
• behavioural sleep wake rhythms assessed with actigraphy • sleep wake rhythm assessed with sleep wake diaries • peripheral clock rhythms by non-invasive collection of buccal cells • fasting plasma glucose and fasting plasma insulin at 6-month and 12-months follow up (this will only be assessed in groups 1 and 2)	—

Countries

Netherlands

Outcome results