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

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.

Conditions

• Parkinsonian Disorders

Interventions

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

Sponsors & Collaborators

• Ministry of Health, France

  collaborator OTHER_GOV

• University Hospital, Toulouse

  lead OTHER

Principal Investigators

• Anne Pavy-Le Traon, MD · University Hospital, Toulouse

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

35 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2019-12-20

Completion

2020-06-30

Countries

• France

Study Locations