NCT05314855

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

January 4, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

March 7, 2022

Last Update Submit

January 5, 2026

Conditions

Type 2 DiabetesInsulin Resistance

Keywords

Type 2 Diabetes MellitusInsulin resistanceSuprachiasmatic nucleusfunctional MRI

Outcome Measures

Primary Outcomes (4)

  • SCN blood oxygen level dependent (BOLD) response to light: mean SCN activity

    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 point (zeitgeber time in hh:mm)

    24 hours

  • SCN BOLD) response to light: time point of trough SCN activity

    time point (zeitgeber time in hh:mm)

    24 hours

  • Amplitude of SCN activity rhythm (peak-trough change in SCN activity)

    Peak-trough difference in SCN activity (percent BOLD signal change)

    24 hours

Study Arms (3)

Obese individuals with normal insulin sensitivity

Device: functional MRI

Obese individuals with impaired insulin sensitivity

Device: functional MRI

Obese patients with type 2 diabetes

Device: functional MRI

Interventions

functional MRIDEVICE

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

Obese individuals with impaired insulin sensitivityObese individuals with normal insulin sensitivityObese patients with type 2 diabetes

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinics, community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Centers, location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (8)

  • World Health Organization, Global report on diabetes., in WHO Library. 2016

    BACKGROUND

  • Cleland SJ, Fisher BM, Colhoun HM, Sattar N, Petrie JR. Insulin resistance in type 1 diabetes: what is 'double diabetes' and what are the risks? Diabetologia. 2013 Jul;56(7):1462-70. doi: 10.1007/s00125-013-2904-2. Epub 2013 Apr 24.

    PMID: 23613085BACKGROUND

  • Stenvers DJ, Scheer FAJL, Schrauwen P, la Fleur SE, Kalsbeek A. Circadian clocks and insulin resistance. Nat Rev Endocrinol. 2019 Feb;15(2):75-89. doi: 10.1038/s41574-018-0122-1.

    PMID: 30531917BACKGROUND

  • Hogenboom R, Kalsbeek MJ, Korpel NL, de Goede P, Koenen M, Buijs RM, Romijn JA, Swaab DF, Kalsbeek A, Yi CX. Loss of arginine vasopressin- and vasoactive intestinal polypeptide-containing neurons and glial cells in the suprachiasmatic nucleus of individuals with type 2 diabetes. Diabetologia. 2019 Nov;62(11):2088-2093. doi: 10.1007/s00125-019-4953-7. Epub 2019 Jul 20.

    PMID: 31327049BACKGROUND

  • ter Horst KW, Gilijamse PW, Koopman KE, de Weijer BA, Brands M, Kootte RS, Romijn JA, Ackermans MT, Nieuwdorp M, Soeters MR, Serlie MJ. Insulin resistance in obesity can be reliably identified from fasting plasma insulin. Int J Obes (Lond). 2015 Dec;39(12):1703-9. doi: 10.1038/ijo.2015.125. Epub 2015 Jul 9.

    PMID: 26155920BACKGROUND

  • American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.

    PMID: 25537714BACKGROUND

  • Roenneberg T, Kuehnle T, Pramstaller PP, Ricken J, Havel M, Guth A, Merrow M. A marker for the end of adolescence. Curr Biol. 2004 Dec 29;14(24):R1038-9. doi: 10.1016/j.cub.2004.11.039. No abstract available.

    PMID: 15620633BACKGROUND

  • World report on vision. Geneva: World Health Organization. 2019

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Dr. D.J. Stenvers

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2022

First Posted

April 6, 2022

Study Start

January 4, 2023

Primary Completion

January 18, 2025

Study Completion

November 1, 2025

Last Updated

January 7, 2026

Record last verified: 2025-12

Locations

NL(1)