Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease
Recruitment status was: Recruiting
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).
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease|
- The primary outcome is the plasma glucose concentration measured 120 min after the oral glucose surcharge intake. [ Time Frame: 120 min after the oral glucose surcharge intake. ]
- Plasma insulin concentration kinetic [ Time Frame: at T0, T30, T60, T90, T120, T150 and T180 ]
- Plasma glucose concentration kinetic [ Time Frame: at T0, T30, T60, T90, T120, T150 and T180 ]
- Urinary glucose measurement [ Time Frame: at T0 and T120 ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Behavioral: Protein and calorie controlled diet
Inclusion visit :
- Clinical examination/ Interview on health and medical history
- Complete UPDRS, MMS
- Biologic check up
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114321
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Franck DURIF, PUPH||University Hospital, Clermont-Ferrand|