Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in Parkinson's Disease
NCT ID: NCT00663312
Last Updated: 2008-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2008-04-30
2008-06-30
Brief Summary
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However, this surgery induces a post-operative body weight gain which may limit the benefits of this technique and induce critical metabolic disorders such as profound alterations in the central control of energy metabolism. Previous data seems to show that glucose metabolism is also altered.
The aim of this prospective study was to identify if the STN stimulation could modify glucose metabolism regulation especially the endogen glucose production (by liver) Hypothalamus is able to detect glucose concentration variations and to control/adjust glucose levels by modulating the hepatic glucose production. As hypothamus and STN are anatomically closed, we hypothesise that the STN stimulation could modulate the hypothalamus function and consequently modify glucose production.
Detailed Description
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Inclusion visit :
* Clinical examination/ Interview on health and medical history
* Complete UPDRS
* Body composition measured by DEXA
* Biologic check up
* MMS
Protocol :
All subjects were studied in the postabsorptive state after a 10-h overnight fast.
On the day of the experiment, patients do not receive their treatment (MED OFF). One catheter was retrogradely inserted into a dorsal vain and was used for blood sample. A second catheter was inserted into the controlateral arm for the tracer infusion. A continuous infusion of D-6,6 2H2 glucose (0,05mg/kg/h) was performed during 6 hours (after a primed dose of 0,05 mg/kg of this tracer).
The first 3 hours, patients were studied without stimulation (STIM OFF); the last 3 hours the stimulator was actuated (STIM ON). Blood samples were regularly collected for the 2H2 glucose enrichment determination, and for the insulin, glucose and glucagon plasma concentration analyses.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Interventions
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e.g., Protein and calorie controlled diet; Self-hypnotic relaxation
Pilot description
Eligibility Criteria
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Inclusion Criteria
* Patient with an idiopathic Parkinson's disease according to the criteria of the "Parkinson's Disease Society Brain Bank" (Hughes et al., 1992)
* Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
* Effect of the stimulation 50%
* Weight gain \>5% (after surgery compared to before surgery)
* MMS\>24/30
* No treatment modification 7 days before the inclusion
* Affiliation to social security
* Agreement of patients
Exclusion Criteria
* Patients with significant heart, respiratory, psychiatric, metabolic, hepatic, kidney diseases; diabetes, heart deficiency, chronic kidney deficiency, untreated thyroid disease …
* 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
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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CHU Clermont-Ferrand
Principal Investigators
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Franck Durif, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU
Clermont-Ferrand, , France
Countries
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References
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Batisse-Lignier M, Rieu I, Guillet C, Pujos E, Morio B, Lemaire JJ, Durif F, Boirie Y. Deep brain stimulation of the subthalamic nucleus regulates postabsorptive glucose metabolism in patients with Parkinson's disease. J Clin Endocrinol Metab. 2013 Jun;98(6):E1050-4. doi: 10.1210/jc.2012-3838. Epub 2013 Apr 30.
Other Identifiers
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CHU-0031
Identifier Type: -
Identifier Source: org_study_id