Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

January 18, 2011 updated by: University Hospital, Clermont-Ferrand

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand
      • Clermont-Ferrand, France, 63003
        • Not yet recruiting
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
120 min after the oral glucose surcharge intake.

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma insulin concentration kinetic
Time Frame: at T0, T30, T60, T90, T120, T150 and T180
at T0, T30, T60, T90, T120, T150 and T180
Plasma glucose concentration kinetic
Time Frame: at T0, T30, T60, T90, T120, T150 and T180
at T0, T30, T60, T90, T120, T150 and T180
Urinary glucose measurement
Time Frame: at T0 and T120
at T0 and T120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Franck Durif, PUPH, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

April 30, 2010

First Posted (Estimate)

May 3, 2010

Study Record Updates

Last Update Posted (Estimate)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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