Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- The primary outcome is the plasma glucose concentration measured 120 min after the oral glucose surcharge intake.
研究概览
简要总结
Dysfunction of autonomic nervous system is an important non motor feature of Parkinson' disease (PD). Lewy body formation is widely distributed in hypothalamus and in sympathetic and parasympathetic systems. Animal studies suggest a link between hypothalamus sensing of substrates and glucose metabolism. Thus, hypothalamus lesions could lead to change in glucose metabolism. Recently, we showed that fasting blood glucose level was significantly higher in PD patients than in control group suggesting that glucose tolerance may be impaired in PD. Some studies provided evidence for higher diabetes prevalence in PD patients whereas others showed no difference or a reduced risk of diabetes prevalence in PD patients compared to healthy subjects.
So, the risk that a PD patient develops a glucose intolerance or a diabetes is not clearly established and merit to be studied considering the damageable consequences for patient healthy.
The aim of this prospective study was to determine the risk that a PD patient develop a glucose intolerance or a diabetes compared to a matched control group, using an oral glucose tolerance test (OGTT).
详细描述
50 patients
Inclusion visit :
- Clinical examination/ Interview on health and medical history
- Complete UPDRS, MMS
- Biologic check up
Protocol :
All patients 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
- Single Group
- 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" with a duration of disease >5years
- •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 …
- •Patient treated with a deep brain stimulation
- •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 plasma glucose concentration measured 120 min after the oral glucose surcharge intake.
时间窗: 120 min after the oral glucose surcharge intake.
次要结局
- Plasma insulin concentration kinetic(at T0, T30, T60, T90, T120, T150 and T180)
- Urinary glucose measurement(at T0 and T120)
- Plasma glucose concentration kinetic(at T0, T30, T60, T90, T120, T150 and T180)