Brain Clock and Insulin Resistance

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Description

In this observational cohort study the investigators will determine the activity rhythm of the suprachiasmatic nucleus in humans with progressive stages of insulin resistance, using advanced functional brain imaging (7 Tesla functional MRI).

Study Overview

Start Date
January 4, 2023
Completion Date
July 1, 2025
Enrollment
30
Date Posted
April 6, 2022
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Amsterdam University Medical Centers, location AMC
Amsterdam, Noord-Holland 1105AZ, Netherlands

Eligibility

Study Population
Primary care clinics, community sample
Minimum Age (years)
25
Maximum Age (years)
65
Eligibility Criteria
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
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≤ 4.5

Group 2: obese people with insulin resistance

age 25-65 years
BMI>30
fasting plasma insulin >62 pmol/L
not fulfilling the American Diabetes Association (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 Diagnostic and Statistical Manual of Mental Disorders (DSM) 5
Disorders of the central nervous system (Early-onset dementia, stroke, epilepsy, Parkinson's disease, brain tumor)
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 glucagon-like peptide (GLP) 1 agonists
MRI contraindications

Study Contact Info

Study Contact Name
E.M. Speksnijder
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
Type 2 diabetes mellitus (T2DM) has an increasing worldwide incidence. Insulin resistance is a key pathophysiological process in the development of hyperglycemia in patients with T2DM. Disruption of circadian synchrony leads to insulin resistance. Animal studies and post-mortem human brain studies suggest that the master brain clock in the hypothalamic suprachiasmatic nucleus (SCN) plays a role in the development of insulin resistance. Up to now, no-one has investigated whether the in vivo activity rhythm of the SCN is affected in patients with insulin resistance. The investigators hypothesize that the master brain clock has an important role in the development of human insulin resistance.
NCTid (if applicable)
NCT05314855