Status:
COMPLETED
Brain Clock and Insulin Resistance
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Insulin Resistance
Type 2 Diabetes
Eligibility:
All Genders
25-65 years
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 functiona...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05314855
Start Date
January 4 2023
End Date
November 1 2025
Last Update
January 7 2026
Active Locations (1)
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1
Amsterdam University Medical Centers, location AMC
Amsterdam, North Holland, Netherlands, 1105AZ