diabetes glucose metabolism disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Informed consent DM1 on stable continuous subcutaneous insulin infusion HbA1c levels 18 and
Exclusion criteria
Exclusion criteria: •Presence of sleep disorders determined by validated sleep questionnaires (Pittsburg sleep quality index (PSQI), Epworth Sleepiness scale (ESS), and Berlin Questionnaire (BQ) •Psychiatric disorders and/or use antipsychotic or antidepressant drugs at present •Nights shifts within the last 3 months •Pregnancy •Chronic use of sleep medication and/or melatonin •Use of medication known to affect glucose metabolism (e.g. prednisone, beta-blocking agents) •Use of prokinetic drugs or aspirin •Renal, hepatic or other endocrine disease •Traveling across time zones
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Glucoregulation by subcutaneous continuous glucose sensor: i.e. mean night glucose • Basal postabsorptive glucose metabolism: plasma glucose and insulin levels, endogenous glucose production (EGP), rate of appearance of glucose (Ra), rate of disappearance of glucose (Rd ) of glucose measured by infusion of [6,6-2H2] glucose • Insulin-mediated glucose metabolism by hyperinsulinemic euglycemic clamp technique: endogenous glucose production (EGP), rate of appearance of glucose (Ra), rate of disappearance of glucose (Rd ) of glucose measured by infusion of [6,6-2H2] glucose, glucose infusion rate (GIR) • Indirect calorimetry: resting energy expenditure and respiratory coefficient (RQ), glucose and lipid oxidation rates • Objective sleep characteristics by polysomnography (PSG) : total sleep time (TST), % REM sleep, % stage 1 sleep, % stage 2 sleep, % stage 3 (SWS) sleep, % wake, apnea-hypopnea index (AHI), heart rate (HR) • Sympathetic activity by heart rate variability (HRV) by PSG • Subjective sleep and daytime sleepiness by validated sleep questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| • Sleep-wake cycle by Actigraphy • Diaries: caloric intake, physical activity, actigraphy •Plasma concentrations: total cholesterol (TC), HDL-C, LDL-C, triglycerides (TG),glucose, insulin, glucagon, free fatty acid (FFA), total glycerol, leptin, cortisol, growth hormone(GH), lactate, isotope enrichment of [6,6-2H2] glucose | — |
Countries
Netherlands