Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Protein and calorie controlled diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Protein and calorie controlled diet|Protein and calorie controlled diet Self-hypnotic relaxation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the plasma glucose concentration measured 120 min after the oral glucose surcharge intake. |  | 120 min after the oral glucose surcharge intake. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma insulin concentration kinetic |  | at T0, T30, T60, T90, T120, T150 and T180 | 
| Plasma glucose concentration kinetic |  | at T0, T30, T60, T90, T120, T150 and T180 | 
| Urinary glucose measurement |  | at T0 and T120 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Parkinson's disease, Glucose intolerance, Diabetes, OGTT, Patient with an Idiopathic Parkinson's disease