- ICH GCP
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- Essai clinique NCT00663312
Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in Parkinson's Disease
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Clermont-Ferrand, France, 63000
- CHU
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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The primary outcome is the hepatic glucose production determined using the 2H2 glucose enrichment measurement and the infusion flow.
Délai: The hepatic glucose production was calculated during OFF stimulation period and ON stimulation period
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The hepatic glucose production was calculated during OFF stimulation period and ON stimulation period
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
-Insulin plasma concentration kinetic -Glucose plasma concentration kinetic -Glucagon plasma concentration kinetic
Délai: During plasma concentration kinetic
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During plasma concentration kinetic
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Franck Durif, Pr, University Hospital, Clermont-Ferrand
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Troubles parkinsoniens
- Maladies des noyaux gris centraux
- Troubles du mouvement
- Synucleinopathies
- Maladies neurodégénératives
- Maladie de Parkinson
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Hypnotiques et sédatifs
Autres numéros d'identification d'étude
- CHU-0031
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