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
  Purpose

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).


Condition Intervention
Parkinson's Disease
Behavioral: Protein and calorie controlled diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
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)
Intervention Details:
    Behavioral: Protein and calorie controlled diet
    Protein and calorie controlled diet Self-hypnotic relaxation
Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114321

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Franck DURIF, PUPH University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01114321     History of Changes
Other Study ID Numbers: CHU-0070
Study First Received: April 29, 2010
Last Updated: January 18, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Idiopathic Parkinson's disease
Glucose intolerance
Diabetes
OGTT
Patient with an Idiopathic Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014