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NCT Number: NCT00529724

Body Weight Gain, Parkinson, Subthalamic Stimulation

Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU

Clermont-Ferrand, 63003, France

About this study

Patients will be studied before (between 3 and 1 months) and after (1 month) STN-DBS surgery. Each time the same measurements will be taken. The principal ones will be :

  • Clinical examination
  • Autoevaluation dietary questionnaire
  • Biological tests
  • Study in calorimetry chamber (only in Clermont-Ferrand centre)
  • Heart rate recorded during 7 days in usual conditions of life
  • Energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)
  • Acute Ldopa challenge (in both conditions of dopa and stim)
  • Apathy evaluation
  • Body weight, and body compositions measurements

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 70 years old
  • Diagnosis of Parkinson' disease established for 5 years at least
  • Ldopa effect > 50 %
  • Hoehn and Yarh score > 2.5 in On phase

Exclusion criteria

  • Metabolism disorder
  • Biological analysis abnormal

Treatment and study plan

Energy metabolism by chronic bilateral subthalamic stimulation

Behavioral

Patients will be studied before and after STN-DBS surgery

Primary outcomes

  1. heart rate recorded during 7 days in usual conditions of life

    Time frame: 7 days in usual conditions of life

  2. energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)

    Time frame: 14 days in usual conditions of life

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Mechanisms of Body Weight Gain in Patients With Parkinson's Disease After Subthalamic Stimulation

Important dates

Study start
2007
Primary completion
2015
Study completion
2018
First posted
Sep 14, 2007
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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