Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01114321
• Other study ID #: CHU-0070
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2010
• Last updated: January 18, 2011
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Protein and calorie controlled diet
Protein and calorie controlled diet Self-hypnotic relaxation

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Plasma insulin concentration kinetic		at T0, T30, T60, T90, T120, T150 and T180	Yes
Secondary	Plasma glucose concentration kinetic		at T0, T30, T60, T90, T120, T150 and T180	Yes
Secondary	Urinary glucose measurement		at T0 and T120	Yes