Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

Status Recruiting

Clinical Trial 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).

Clinical Trial 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). ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01114321
Study type	Interventional
Source	University Hospital, Clermont-Ferrand
Contact	Patrick LACARIN
Phone	04 73 75 11 95
Email	placarin@chu-clermontferrand.fr
Status	Recruiting
Phase	N/A
Start date	May 2010
Completion date	December 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.