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The interaction between glycemic control and sleep characteristics in patients with type 1 Diabetes Mellitus

The interaction between glycemic control and sleep characteristics in patients with type 1 Diabetes Mellitus - Interaction between glucoregulation and sleep in patients with DM1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34292
Enrollment
20
Registered
2011-01-06
Start date
2010-08-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes glucose metabolism disorders

Interventions

normoglycemic vs. hyperglycemic condition normal sleep vs. selective suppression of the slow-wave sleep

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)