Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The primary outcome is the hepatic glucose production determined using the 2H2 glucose enrichment measurement and the infusion flow.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The primary outcome is the hepatic glucose production determined using the 2H2 glucose enrichment measurement and the infusion flow.
时间窗: The hepatic glucose production was calculated during OFF stimulation period and ON stimulation period
次要结局
- -Insulin plasma concentration kinetic -Glucose plasma concentration kinetic -Glucagon plasma concentration kinetic(During plasma concentration kinetic)