Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00663312
Recruitment Status : Terminated
First Posted : April 22, 2008
Last Update Posted : October 8, 2008
Information provided by:
University Hospital, Clermont-Ferrand

Brief Summary:

Parkinson' disease is a neurodegenerative disorder characterised by bradykinesia, rigidity, rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine agonists usually leads to a dramatic improvement of symptoms, but disease progression nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus (STN) leads to a spectacular clinical improvement in patients with motor complications and is now considered as the gold standard surgical treatment.

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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Behavioral: e.g., Protein and calorie controlled diet; Self-hypnotic relaxation Not Applicable

Detailed Description:

ilot study 8 patients

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in Parkinson's Disease
Study Start Date : April 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: e.g., Protein and calorie controlled diet; Self-hypnotic relaxation
    Pilot description

Primary Outcome Measures :
  1. The primary outcome is the hepatic glucose production determined using the 2H2 glucose enrichment measurement and the infusion flow. [ Time Frame: The hepatic glucose production was calculated during OFF stimulation period and ON stimulation period ]

Secondary Outcome Measures :
  1. -Insulin plasma concentration kinetic -Glucose plasma concentration kinetic -Glucagon plasma concentration kinetic [ Time Frame: During plasma concentration kinetic ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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" (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 :

  • 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 …
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00663312

Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Principal Investigator: Franck Durif, Pr University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pr Llorca, CHU Clermont-Ferrand Identifier: NCT00663312     History of Changes
Other Study ID Numbers: CHU-0031
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: October 8, 2008
Last Verified: October 2008

Keywords provided by University Hospital, Clermont-Ferrand:
Idiopathic Parkinson's disease
Deep Brain stimulation
Hepatic glucose production
Weight gain
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
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs