adult-onset diabetes type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Participants are able to provide signed and dates written consent prior to any study specific procedures • Male + females (postmenopausal defined as at least 1 year post cessation of menses) • T2D duration at least 1 year • BMI: >= 25 kg/m² • Age: 40-75 • Well-controlled diabetes with respect to glycemic control and on stable anti-diabetes medication regimes • Habitual bedtime of 23:00 ± 2h • Regular sleep duration (7-9 h/night) • Stable dietary habits: no weight gain or loss > 5 kg in the last three months
Exclusion criteria
Exclusion criteria: • Insulin treatment • Uncontrolled hypertension • Signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy • Signs of active liver or kidney malfunction • Use of SGLT2 inhibitors • Using > 400mg caffeine daily (more than 4 coffee or energy drink) • Extreme early bird or extreme night person (score =70 on MEQ-SA questionnaire) • shift work or travel across more than one time zone in the 3 months before the study • Heavily varying sleep-wake rhythm • engagement in programmed exercise for more than 3h/week • Any medication that will interfere with the study outcomes or hamper the safety of the participant • Alcohol consumption of >2 servings per day for man and >1 serving per day for woman • Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, 1 month prior to the screening visit • Significant food allergies/intolerance (seriously hampering study meals) • Participation in another biomedical study within 1 month before the first study visit • Smoking in the past 6 months A medical doctor will judge participation eligibility based on the medical history questionnaire, medication use and fasting blood parameters. If the medical doctor advises that a patient cannot participate, the patient will be excluded from enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is average 24h blood glucose assessed with a continuous glucose monitor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints refer to postprandial metabolism upon a mixed-meal tolerance test and circadian transcriptome, lipidome and myokine secretion analyses in skeletal muscle tissue with culturing of human primary myotubes to assess circadian reporter characteristics. Other exploratory parameters include: • 24h blood profiles: o metabolic compounds (glucose, triglycerides, free fatty acids) o hormones (insulin) o mass spectrometry-based lipidomics • Sleep quality questionnaires: LSEQ and PSQI • 24h indirect calorimetry: substrate metabolism and energy expenditure • Actigraphy measures: activity count, sleeping times • 24h blood pressure and heart rate (ambulatory) • 24h saliva profiles: o Melatonin and cortisol • Core body temperature and skin temperatures • mRNA and protein levels in blood PBMC*s of markers involved in the molecular clock • Body composition (BodPod) | — |
Countries
Netherlands