Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01114321
First received: April 29, 2010
Last updated: January 18, 2011
Last verified: January 2011

April 29, 2010
January 18, 2011
May 2010
May 2013   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01114321 on ClinicalTrials.gov Archive Site
  • Plasma insulin concentration kinetic [ Time Frame: at T0, T30, T60, T90, T120, T150 and T180 ] [ Designated as safety issue: Yes ]
  • Plasma glucose concentration kinetic [ Time Frame: at T0, T30, T60, T90, T120, T150 and T180 ] [ Designated as safety issue: Yes ]
  • Urinary glucose measurement [ Time Frame: at T0 and T120 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease
Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

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).

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).

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Parkinson's Disease
Behavioral: Protein and calorie controlled diet
Protein and calorie controlled diet Self-hypnotic relaxation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01114321
CHU-0070
Not Provided
Patrick LACARIN, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Franck DURIF, PUPH University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP