NCT02021903

Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies

Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies: the Model of an Oral Glucose Load

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It is a major complain and represents a socially relevant problem as unintended episodes of sleep can also occur while driving for example. Arterial hypotension is frequently observed in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness is known to occur preferentially when patients are having arterial hypotension whatever the cause (i.e. postprandial period, administration of hypotensive medication such as dopamine agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness. We have observed this association in an on-going epidemiological survey Hyperglycaemia induced by oral glucose load - a standardized model simulating food intake during a meal - provokes arterial hypotension in the majority of Parkinson's disease patients with dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated by this fall in blood pressure.

Detailed description

Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It is a major complain and represents a socially relevant problem as unintended episodes of sleep can also occur while driving for example. The exact pathophysiology of EDS in PD, DLB and MSA has not been fully elucidated so far, although pharmacological factors (dopaminergic medications) and pathological factors (neurodegeneration of sleep-wakefulness regulatory areas) have been identified. Arterial hypotension is frequently observed in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness is known to occur preferentially when patients are having arterial hypotension whatever the cause (i.e. postprandial period, administration of hypotensive medication such as dopamine agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness. We have observed this association in an on-going epidemiological survey (COPARK Cohort of 800 PD patients, manuscript in preparation). Hyperglycaemia induced by oral glucose load - a standardized model simulating food intake during a meal - provokes arterial hypotension in the majority of Parkinson's disease patients with dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated by this fall in blood pressure.

Conditions

• Parkinsonian Disorders

Interventions

Type	Name	Description
OTHER	V1: HGPO + meal and V2: placebo + meal	* Ambulatory polysomnography for the night preceding each test * Usual antiparkinsonian treatments at their usual dose and timing * Randomisation to receive an oral solution of glucose load or a placebo (fructose). Standard meal 4 hours after the test * During two hours following the oral solution administration and the standardized meal, we will perform the followings for each patient : * continuous digital blood pressure monitoring by Nexfin® * blood pressure monitoring at brachial artery * continuous polysomnographic recording * synchronized continuous digital audiovisual recording * glucose and insulin blood level monitoring Additional blood samples will be taken in order to assay the intestine-pancreatic neuropeptides including incretins GLP- 1 and GIP
OTHER	V1: placebo 75mg + meal and V2: HGPO 75mg + meal	* Ambulatory polysomnography for the night preceding each test * Usual antiparkinsonian treatments at their usual dose and timing * Randomisation to receive an oral solution of glucose load or a placebo (fructose). Standard meal 4 hours after the test * During two hours following the oral solution administration and the standardized meal, we will perform the followings for each patient : * continuous digital blood pressure monitoring by Nexfin® * blood pressure monitoring at brachial artery * continuous polysomnographic recording * synchronized continuous digital audiovisual recording * glucose and insulin blood level monitoring Additional blood samples will be taken in order to assay the intestine-pancreatic neuropeptides including incretins GLP- 1 and GIP

Timeline

• Start date: 2012-05-01
• Primary completion: 2019-12-20
• Completion: 2020-06-01
• First posted: 2013-12-27
• Last updated: 2020-08-25

Locations

2 sites across 1 country: France