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Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Protein and calorie controlled diet
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Idiopathic Parkinson's disease, Glucose intolerance, Diabetes, OGTT, Patient with an Idiopathic Parkinson's disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand
  • Chu Clermont-FerrandRecruiting

Outcomes

Primary Outcome Measures

The primary outcome is the plasma glucose concentration measured 120 min after the oral glucose surcharge intake.

Secondary Outcome Measures

Plasma insulin concentration kinetic
Plasma glucose concentration kinetic
Urinary glucose measurement

Full Information

First Posted
April 29, 2010
Last Updated
January 18, 2011
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT01114321
Brief Title
Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease
Official Title
Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Idiopathic Parkinson's disease, Glucose intolerance, Diabetes, OGTT, Patient with an Idiopathic Parkinson's disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Protein and calorie controlled diet
Intervention Description
Protein and calorie controlled diet Self-hypnotic relaxation
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Plasma insulin concentration kinetic
Time Frame
at T0, T30, T60, T90, T120, T150 and T180
Title
Plasma glucose concentration kinetic
Time Frame
at T0, T30, T60, T90, T120, T150 and T180
Title
Urinary glucose measurement
Time Frame
at T0 and T120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck DURIF, PUPH
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
35296961
Citation
Beze S, Castellani L, Pereira B, Chiambaretta F, Durif F, Marques A. Two-year longitudinal follow-up of visual illusions and hallucinations in Parkinson's disease. J Neurol. 2022 Aug;269(8):4546-4554. doi: 10.1007/s00415-022-11074-2. Epub 2022 Mar 16.
Results Reference
derived
PubMed Identifier
32447550
Citation
Marques A, Beze S, Pereira B, Chassain C, Monneyron N, Delaby L, Lambert C, Fontaine M, Derost P, Debilly B, Rieu I, Lewis SJG, Chiambaretta F, Durif F. Visual hallucinations and illusions in Parkinson's disease: the role of ocular pathology. J Neurol. 2020 Oct;267(10):2829-2841. doi: 10.1007/s00415-020-09925-x. Epub 2020 May 23.
Results Reference
derived
PubMed Identifier
29866628
Citation
Marques A, Dutheil F, Durand E, Rieu I, Mulliez A, Fantini ML, Boirie Y, Durif F. Glucose dysregulation in Parkinson's disease: Too much glucose or not enough insulin? Parkinsonism Relat Disord. 2018 Oct;55:122-127. doi: 10.1016/j.parkreldis.2018.05.026. Epub 2018 May 31.
Results Reference
derived

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Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

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