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

Primary Purpose

Idiopathic Parkinson's Disease

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

e.g., Protein and calorie controlled diet; Self-hypnotic relaxation

About this trial

This is an interventional diagnostic trial for Idiopathic Parkinson's Disease focused on measuring Idiopathic Parkinson's disease, Deep Brain stimulation, Hepatic glucose production, Insulin, Weight gain, 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" (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

Sites / Locations

Outcomes

Primary Outcome Measures

The primary outcome is the hepatic glucose production determined using the 2H2 glucose enrichment measurement and the infusion flow.

Secondary Outcome Measures

-Insulin plasma concentration kinetic -Glucose plasma concentration kinetic -Glucagon plasma concentration kinetic

Full Information

NCT ID

NCT00663312

First Posted

April 14, 2008

Last Updated

October 7, 2008

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT00663312

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Terminated

Study Start Date

April 2008 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Parkinson's Disease

Keywords

Idiopathic Parkinson's disease, Deep Brain stimulation, Hepatic glucose production, Insulin, Weight gain, Patient with an Idiopathic Parkinson's disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

e.g., Protein and calorie controlled diet; Self-hypnotic relaxation

Intervention Description

Pilot description

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

-Insulin plasma concentration kinetic -Glucose plasma concentration kinetic -Glucagon plasma concentration kinetic

Time Frame

During plasma concentration kinetic

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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" (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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franck Durif, Pr

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU

City

Clermont-Ferrand

ZIP/Postal Code

63000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

23633215

Citation

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.

Results Reference

derived

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

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