Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

NCT01114321 | Unknown

• 1 other identifier: CHU-0070
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Parkinson's Disease

Keywords

Idiopathic Parkinson's disease; Glucose intolerance; Diabetes; OGTT; Patient with an Idiopathic Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the plasma glucose concentration measured 120 min after the oral glucose surcharge intake.

  120 min after the oral glucose surcharge intake.

Secondary Outcomes (3)

• Plasma insulin concentration kinetic

  at T0, T30, T60, T90, T120, T150 and T180

• Plasma glucose concentration kinetic

  at T0, T30, T60, T90, T120, T150 and T180

• Urinary glucose measurement

  at T0 and T120

Interventions

Protein and calorie controlled diet BEHAVIORAL

Protein and calorie controlled diet Self-hypnotic relaxation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Affiliation to social security
• Agreement of patients

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

NOT YET RECRUITING

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (3)

• Beze S, Castellani L, Pereira B, Chiambaretta F, Durif F, Marques A. Two-year longitudinal follow-up of visual illusions and hallucinations in Parkinson's disease. J Neurol. 2022 Aug;269(8):4546-4554. doi: 10.1007/s00415-022-11074-2. Epub 2022 Mar 16.

  PMID: 35296961 DERIVED

• Marques A, Beze S, Pereira B, Chassain C, Monneyron N, Delaby L, Lambert C, Fontaine M, Derost P, Debilly B, Rieu I, Lewis SJG, Chiambaretta F, Durif F. Visual hallucinations and illusions in Parkinson's disease: the role of ocular pathology. J Neurol. 2020 Oct;267(10):2829-2841. doi: 10.1007/s00415-020-09925-x. Epub 2020 May 23.

  PMID: 32447550 DERIVED

• Marques A, Dutheil F, Durand E, Rieu I, Mulliez A, Fantini ML, Boirie Y, Durif F. Glucose dysregulation in Parkinson's disease: Too much glucose or not enough insulin? Parkinsonism Relat Disord. 2018 Oct;55:122-127. doi: 10.1016/j.parkreldis.2018.05.026. Epub 2018 May 31.

  PMID: 29866628 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Glucose Intolerance; Diabetes Mellitus

Interventions

Proteins; Caloric Restriction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Franck DURIF, PUPH

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 19, 2011

Record last verified: 2011-01

Locations

FR (2)