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

Idiopathic Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00663312
• Other study ID #: CHU-0031
• Status: Terminated
• Phase: N/A
• First received: April 14, 2008
• Last updated: October 7, 2008
• Start date: April 2008
• Est. completion date: June 2008

Study information

• Verified date: October 2008
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
France	CHU	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the hepatic glucose production determined using the 2H2 glucose enrichment measurement and the infusion flow.		The hepatic glucose production was calculated during OFF stimulation period and ON stimulation period	Yes
Secondary	-Insulin plasma concentration kinetic -Glucose plasma concentration kinetic -Glucagon plasma concentration kinetic		During plasma concentration kinetic	Yes