Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention |
|---|---|
|
Parkinson's Disease |
Behavioral: Protein and calorie controlled diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease |
- The primary outcome is the plasma glucose concentration measured 120 min after the oral glucose surcharge intake. [ Time Frame: 120 min after the oral glucose surcharge intake. ] [ Designated as safety issue: Yes ]
- Plasma insulin concentration kinetic [ Time Frame: at T0, T30, T60, T90, T120, T150 and T180 ] [ Designated as safety issue: Yes ]
- Plasma glucose concentration kinetic [ Time Frame: at T0, T30, T60, T90, T120, T150 and T180 ] [ Designated as safety issue: Yes ]
- Urinary glucose measurement [ Time Frame: at T0 and T120 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
-
Behavioral: Protein and calorie controlled diet
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.
On the day of the experiment, patients did not receive their treatment. One catheter was inserted for blood sample collections. Patients ingested then 75 g of glucose.
Blood samples were collected for plasma glucose and plasma insulin concentration analyses at T0, T30, T60, T90, T120, T150 and T180. Urinary glucose was researched at T0 and T120.
In parallel, a dysautonomia evaluation of each patient was made (SCOPA AUT questionnaire, Tilt test).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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" with a duration of disease >5years
- 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 …
- 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
Contacts and Locations| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| France | |
| CHU Clermont-Ferrand | Not yet recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
| Chu Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
| Principal Investigator: | Franck DURIF, PUPH | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | Patrick LACARIN, CHU Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01114321 History of Changes |
| Other Study ID Numbers: | CHU-0070 |
| Study First Received: | April 29, 2010 |
| Last Updated: | January 18, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Idiopathic Parkinson's disease Glucose intolerance Diabetes OGTT Patient with an Idiopathic Parkinson's disease |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 16, 2013