diabetes mellitus type 2 impaired glucose metabolism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Caucasian • Healthy (as determined by dependent physician based on medical questionnaire) • Male • Age: 40-75 • Overweight: BMI 25 - 35 kg/m2 • Prediabetic based on one or a combination of the following criteria: o Impaired Glucose Tolerance (IGT): plasma glucose values >= 7.8 mmol/l and = 6.1 mmol/l and 3kg in the last three months
Exclusion criteria
Exclusion criteria: • Fasting plasma glucose >= 7.0 mmol/l • Haemoglobin 20 grams alcohol/day • 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 o Claustrophobia o Epilepsy • Any contra-indication to the Equivital telemetric pill: o Known or suspected obstructive disease of the gastrointestinal tract o History of disorders or impairment of the gag reflex o Previous gastrointestinal surgery o Felinization of the esophagus o Hypomotility disorders of the gastro-intestinal tract • Implanted electromedical device • Extreme early bird or extreme night person (score =70 on MEQ-SA questionnaire, document F1-2) • Heavily varying sleep-wake rhythm • Nightshiftwork during last 3 months • Travel across > 1 time zone in the last 3 months • Engagement in exercise > 2 hours total per week • Significant food allergies/intolerance (seriously hampering study meals) • Participation in another biomedical study within 1 month before the first study visit • Using > 400mg caffeine daily (more than 4 coffee or energy drink) • Smoking • Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator*s opinion interfere with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is 24h rhythmicity in substrate metabolism including whole-body energy metabolism (energy expenditure, respiratory quotient). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints refer to 24h blood profile of glucose, insulin, free fatty acids and triglycerides as well as skeletal muscle clock gene expression and mitochondrial respiration. In addition, 24h rhythmicity in core body temperature, salivary melatonin and cortisol and the 24h profile of mRNA and protein levels in peripheral blood mononuclear cells (PBMC*s) involved in the molecular clock. | — |
Countries
Netherlands