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

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00663312
First received: April 14, 2008
Last updated: October 7, 2008
Last verified: October 2008
  Purpose

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 Intervention
Idiopathic Parkinson's Disease
Behavioral: e.g., Protein and calorie controlled diet; Self-hypnotic relaxation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • -Insulin plasma concentration kinetic -Glucose plasma concentration kinetic -Glucagon plasma concentration kinetic [ Time Frame: During plasma concentration kinetic ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: e.g., Protein and calorie controlled diet; Self-hypnotic relaxation
    Pilot description
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.

  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" (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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00663312

Locations
France
CHU
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Franck Durif, Pr University Hospital, Clermont-Ferrand
  More Information

No publications provided by University Hospital, Clermont-Ferrand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Llorca, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00663312     History of Changes
Other Study ID Numbers: CHU-0031
Study First Received: April 14, 2008
Last Updated: October 7, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Idiopathic Parkinson's disease
Deep Brain stimulation
Hepatic glucose production
Insulin
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

ClinicalTrials.gov processed this record on October 01, 2014