Clinical trial NCT01114321: Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease
Official title: Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Idiopathic Parkinson's disease
Glucose intolerance
Diabetes
OGTT
Patient with an Idiopathic Parkinson's disease
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Dysfunction of autonomic nervous system is an important non motor feature of Parkinson' disease (PD). Lewy body formation is widely distributed in hypothalamus and in sympathetic and parasympathetic systems. Animal studies suggest a link between hypothalamus sensing of substrates and glucose metabolism. Thus, hypothalamus lesions could lead to change in glucose metabolism. Recently, we showed that fasting blood glucose level was significantly higher in PD patients than in control group suggesting that glucose tolerance may be impaired in PD. Some studies provided evidence for higher diabetes prevalence in PD patients whereas others showed no difference or a reduced risk of diabetes prevalence in PD patients compared to healthy subjects.

So, the risk that a PD patient develops a glucose intolerance or a diabetes is not clearly established and merit to be studied considering the damageable consequences for patient healthy.

The aim of this prospective study was to determine the risk that a PD patient develop a glucose intolerance or a diabetes compared to a matched control group, using an oral glucose tolerance test (OGTT).

Detailed description: 50 patients

Inclusion visit :

* Clinical examination/ Interview on health and medical history
* Complete UPDRS, MMS
* Biologic check up

Protocol :

All patients were studied in the postabsorptive state after a 10-h overnight fast.

On the day of the experiment, patients did not receive their treatment. One catheter was inserted for blood sample collections. Patients ingested then 75 g of glucose.

Blood samples were collected for plasma glucose and plasma insulin concentration analyses at T0, T30, T60, T90, T120, T150 and T180. Urinary glucose was researched at T0 and T120.

In parallel, a dysautonomia evaluation of each patient was made (SCOPA AUT questionnaire, Tilt test).

Eligibility criteria: Inclusion Criteria:

* Age : 18-70 years
* Patient with an idiopathic Parkinson's disease according to the criteria of the "Parkinson's Disease Society Brain Bank" with a duration of disease \>5years
* MMS\>24/30
* No treatment modification 7 days before the inclusion
* Affiliation to social security
* Agreement of patients

Exclusion Criteria:

* Patient treated with antibiotics, AINS, AIS or other treatment which could interfere with the protocol
* Patients with significant heart, respiratory, psychiatric, metabolic, hepatic, kidney diseases; diabetes, heart deficiency, chronic kidney deficiency, untreated thyroid disease ...
* Patient treated with a deep brain stimulation
* Patients with metabolic and/or biological anomalies
* Pregnant women
* Medical or chirurgical previous history which could interfere with the protocol
* Alcohol (\>30g/day); Tobacco (\>10 cigarettes/day)
* Participation to an other study at the same time

Primary outcomes:
measure: The primary outcome is the plasma glucose concentration measured 120 min after the oral glucose surcharge intake.
timeFrame: 120 min after the oral glucose surcharge intake.
Secondary outcomes:
measure: Plasma insulin concentration kinetic
timeFrame: at T0, T30, T60, T90, T120, T150 and T180
measure: Plasma glucose concentration kinetic
timeFrame: at T0, T30, T60, T90, T120, T150 and T180
measure: Urinary glucose measurement
timeFrame: at T0 and T120
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Franck DURIF, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beze S, Castellani L, Pereira B, Chiambaretta F, Durif F, Marques A. Two-year longitudinal follow-up of visual illusions and hallucinations in Parkinson's disease. J Neurol. 2022 Aug;269(8):4546-4554. doi: 10.1007/s00415-022-11074-2. Epub 2022 Mar 16.
citation: Marques A, Beze S, Pereira B, Chassain C, Monneyron N, Delaby L, Lambert C, Fontaine M, Derost P, Debilly B, Rieu I, Lewis SJG, Chiambaretta F, Durif F. Visual hallucinations and illusions in Parkinson's disease: the role of ocular pathology. J Neurol. 2020 Oct;267(10):2829-2841. doi: 10.1007/s00415-020-09925-x. Epub 2020 May 23.
citation: Marques A, Dutheil F, Durand E, Rieu I, Mulliez A, Fantini ML, Boirie Y, Durif F. Glucose dysregulation in Parkinson's disease: Too much glucose or not enough insulin? Parkinsonism Relat Disord. 2018 Oct;55:122-127. doi: 10.1016/j.parkreldis.2018.05.026. Epub 2018 May 31.