Brain Clock and Insulin Resistance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-04

Study Completion Date

2025-11-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Insulin Resistance Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese individuals with normal insulin sensitivity

functional MRI

Intervention Type DEVICE

Subjects will undergo functional MRI at 4 time points in 24 hours.

Obese individuals with impaired insulin sensitivity

functional MRI

Intervention Type DEVICE

Subjects will undergo functional MRI at 4 time points in 24 hours.

Obese patients with type 2 diabetes

functional MRI

Intervention Type DEVICE

Subjects will undergo functional MRI at 4 time points in 24 hours.

Interventions

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functional MRI

Subjects will undergo functional MRI at 4 time points in 24 hours.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes