Investigating the brain clock's role in insulin resistance and type 2 diabetes
Role of the Central Brain Clock in the Pathophysiology of Insulin Resistance
This study is trying to see how the brain's internal clock affects insulin resistance and type 2 diabetes by looking at different groups of people with varying levels of insulin sensitivity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT05314855 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to explore the activity rhythm of the suprachiasmatic nucleus (SCN) in individuals with varying stages of insulin resistance using advanced 7 Tesla functional MRI technology. The research focuses on understanding how disruptions in circadian rhythms may contribute to insulin resistance and the development of type 2 diabetes mellitus (T2DM). By comparing obese individuals with normal insulin sensitivity, those with insulin resistance, and those with overt T2DM, the study seeks to uncover the in vivo dynamics of the brain's master clock in relation to metabolic health.
Who should consider this trial
Good fit: Ideal candidates include obese individuals aged 25-65 with varying levels of insulin sensitivity, specifically those with normal insulin sensitivity, insulin resistance, or diagnosed type 2 diabetes.
Not a fit: Patients with extreme chronotypes, active psychiatric disorders, central nervous system disorders, severe visual impairments, or those working shifts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the relationship between circadian rhythms and insulin resistance, potentially leading to new therapeutic strategies for managing type 2 diabetes.
How similar studies have performed: While there is existing research on the role of circadian rhythms in metabolic disorders, this specific investigation into the SCN's activity in humans with insulin resistance is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam, Noord-Holland
- Amsterdam University Medical Centers, location AMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Dr. D.J. Stenvers — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: E.M. Speksnijder
- Email: e.m.speksnijder@amsterdamumc.nl
- Phone: +31 20 5666071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.