Brain Clock and Insulin Resistance

January 5, 2026 updated by: Dirk Jan Stenvers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Role of the Central Brain Clock in the Pathophysiology of Insulin Resistance

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

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105AZ
        • Amsterdam University Medical Centers, location AMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Primary care clinics, community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese individuals with normal insulin sensitivity
Device: functional MRI
Subjects will undergo functional MRI at 4 time points in 24 hours.
Obese individuals with impaired insulin sensitivity
Device: functional MRI
Subjects will undergo functional MRI at 4 time points in 24 hours.
Obese patients with type 2 diabetes
Device: functional MRI
Subjects will undergo functional MRI at 4 time points in 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCN blood oxygen level dependent (BOLD) response to light: mean SCN activity
Time Frame: mean activity over 24 hours
SCN BOLD response to light stimulus (percent BOLD signal change)
mean activity over 24 hours
SCN BOLD response to light: time point of peak SCN activity
Time Frame: 24 hours
time point (zeitgeber time in hh:mm)
24 hours
SCN BOLD) response to light: time point of trough SCN activity
Time Frame: 24 hours
time point (zeitgeber time in hh:mm)
24 hours
Amplitude of SCN activity rhythm (peak-trough change in SCN activity)
Time Frame: 24 hours
Peak-trough difference in SCN activity (percent BOLD signal change)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

  • Principal Investigator: Dr. D.J. Stenvers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2023

Primary Completion (Actual)

January 18, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL79698.018.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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