Insulin ResistanceNCT05314855
Brain Clock and Insulin Resistance
An observational study of Insulin Resistance and Type 2 Diabetes, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes
- What is being tested?
- functional MRI
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Jan 2023to 1 Nov 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinics, community sample
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam University Medical Centers, location AMC
Amsterdam, North Holland, 1105AZ
About this study
Official title: 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).
Read the 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.
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Being tested
- functional MRI
- Keywords
- Type 2 Diabetes Mellitus, Insulin resistance, Suprachiasmatic nucleus, functional MRI
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional MRIDevice
Subjects will undergo functional MRI at 4 time points in 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Obese individuals with normal insulin sensitivity | Not described Receives: Device: functional MRI | |
| Obese individuals with impaired insulin sensitivity | Not described Receives: Device: functional MRI | |
| Obese patients with type 2 diabetes | Not described Receives: Device: functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCN blood oxygen level dependent (BOLD) response to light: mean SCN activity
SCN BOLD response to light stimulus (percent BOLD signal change)
Measured: mean activity over 24 hours
SCN BOLD response to light: time point of peak SCN activity
time point (zeitgeber time in hh:mm)
Measured: 24 hours
SCN BOLD) response to light: time point of trough SCN activity
time point (zeitgeber time in hh:mm)
Measured: 24 hours
Amplitude of SCN activity rhythm (peak-trough change in SCN activity)
Peak-trough difference in SCN activity (percent BOLD signal change)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start4 Jan 2023
- Primary completion18 Jan 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Jan Stenvers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Dr. D.J. Stenvers, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314855
- Sponsor's protocol ID
- NL79698.018.21
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
World Health Organization, Global report on diabetes., in WHO Library. 2016
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.
PubMed 23613085Stenvers 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.
PubMed 30531917Hogenboom 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.
PubMed 31327049ter 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.
PubMed 26155920American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.
PubMed 25537714Roenneberg 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.
PubMed 15620633World report on vision. Geneva: World Health Organization. 2019
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Central Brain Clock in the Pathophysiology of Insulin Resistance
- ClinicalTrials.gov ID
- NCT05314855
- Acronym / sponsor ID
- NL79698.018.21
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Keywords
- Type 2 Diabetes Mellitus, Insulin resistance, Suprachiasmatic nucleus, functional MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 18 Jan 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinics, community sample
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional MRISubjects will undergo functional MRI at 4 time points in 24 hours. | Device | Obese individuals with impaired insulin sensitivity, Obese individuals with normal insulin sensitivity, Obese patients with type 2 diabetes |
Primary outcome
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)
SCN BOLD response to light: time point of peak SCN activity
Time frame: 24 hours
time point (zeitgeber time in hh:mm)
SCN BOLD) response to light: time point of trough SCN activity
Time frame: 24 hours
time point (zeitgeber time in hh:mm)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- BackgroundWorld Health Organization, Global report on diabetes., in WHO Library. 2016
- Background: PubMed 23613085Cleland 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.
- Background: PubMed 30531917Stenvers 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.
- Background: PubMed 31327049Hogenboom 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.
- Background: PubMed 26155920ter 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.
- Background: PubMed 25537714American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.
- Background: PubMed 15620633Roenneberg 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.
- BackgroundWorld report on vision. Geneva: World Health Organization. 2019
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. D.J. Stenvers principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Type 2 Diabetes, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCN blood oxygen level dependent (BOLD) response to light: mean SCN activity (time frame: mean activity over 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314855, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.