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

Recruiting

Conditions: De perfusie/activiteit van de centrale hersenklok (SCN)
Insulin resistance
prediabetes
10018424

Registration Number: NL-OMON53722

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Group 1: obese people with normal insulin sensitivity
• age 25-65 years
• BMI>30
• fasting plasma insulin <=62 pmol/L
• fasting plasma glucose <5.6 mmol/L
• HOMA-IR <= 4.5
Group 2: obese people with insulin resistance
• age 25-65 years
• BMI>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

• 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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