Idiopathic Parkinson's DiseaseNCT00663312
Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in Parkinson's Disease
A study of Idiopathic Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No treatment modification 7 days before the inclusion
- Affiliation to social security
- Agreement of patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
On the day of the experiment, patients do not receive their treatment (MED OFF). One catheter was retrogradely inserted into a dorsal vain and was used for blood sample. A second catheter was inserted into the controlateral arm for the tracer infusion. A continuous infusion of D-6,6 2H2 glucose (0,05mg/kg/h) was performed during 6 hours (after a primed dose of 0,05 mg/kg of this tracer).
The first 3 hours, patients were studied without stimulation (STIM OFF); the last 3 hours the stimulator was actuated (STIM ON). Blood samples were regularly collected for the 2H2 glucose enrichment determination, and for the insulin, glucose and glucagon plasma concentration analyses.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- e.g., Protein and calorie controlled diet; Self-hypnotic relaxation
- Keywords
- Idiopathic Parkinson's disease, Deep Brain stimulation, Hepatic glucose production, Insulin, Weight gain, Patient with an Idiopathic Parkinson's disease
- Medical subject headings
- Parkinson Disease, Insulin Resistance, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e.g., Protein and calorie controlled diet; Self-hypnotic relaxationBehavioural
Pilot description
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the hepatic glucose production determined using the 2H2 glucose enrichment measurement and the infusion flow.
Measured: The hepatic glucose production was calculated during OFF stimulation period and ON stimulation period
Secondary outcomes (1)
-Insulin plasma concentration kinetic -Glucose plasma concentration kinetic -Glucagon plasma concentration kinetic
Measured: During plasma concentration kinetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Franck Durif, Pr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663312
- Sponsor's protocol ID
- CHU-0031
- Status last verified
- Oct 2008
- First submitted
- 14 Apr 2008
- Last updated
- 8 Oct 2008
- Results posted
- No
Publications
Batisse-Lignier M, Rieu I, Guillet C, Pujos E, Morio B, Lemaire JJ, Durif F, Boirie Y. Deep brain stimulation of the subthalamic nucleus regulates postabsorptive glucose metabolism in patients with Parkinson's disease. J Clin Endocrinol Metab. 2013 Jun;98(6):E1050-4. doi: 10.1210/jc.2012-3838. Epub 2013 Apr 30.
PubMed 23633215
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00663312
- Acronym / sponsor ID
- CHU-0031
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Idiopathic Parkinson's disease, Deep Brain stimulation, Hepatic glucose production, Insulin, Weight gain, Patient with an Idiopathic Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
On the day of the experiment, patients do not receive their treatment (MED OFF). One catheter was retrogradely inserted into a dorsal vain and was used for blood sample. A second catheter was inserted into the controlateral arm for the tracer infusion. A continuous infusion of D-6,6 2H2 glucose (0,05mg/kg/h) was performed during 6 hours (after a primed dose of 0,05 mg/kg of this tracer).
The first 3 hours, patients were studied without stimulation (STIM OFF); the last 3 hours the stimulator was actuated (STIM ON). Blood samples were regularly collected for the 2H2 glucose enrichment determination, and for the insulin, glucose and glucagon plasma concentration analyses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e.g., Protein and calorie controlled diet; Self-hypnotic relaxationPilot description | Behavioural | – |
Primary outcome
The primary outcome is the hepatic glucose production determined using the 2H2 glucose enrichment measurement and the infusion flow.
Time frame: The hepatic glucose production was calculated during OFF stimulation period and ON stimulation period
1 secondary outcome
-Insulin plasma concentration kinetic -Glucose plasma concentration kinetic -Glucagon plasma concentration kinetic
Time frame: During plasma concentration kinetic
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2008.
- Derived from this study: PubMed 23633215Batisse-Lignier M, Rieu I, Guillet C, Pujos E, Morio B, Lemaire JJ, Durif F, Boirie Y. Deep brain stimulation of the subthalamic nucleus regulates postabsorptive glucose metabolism in patients with Parkinson's disease. J Clin Endocrinol Metab. 2013 Jun;98(6):E1050-4. doi: 10.1210/jc.2012-3838. Epub 2013 Apr 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck Durif, Pr principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Idiopathic Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the hepatic glucose production determined using the 2H2 glucose enrichment measurement and the infusion flow. (time frame: The hepatic glucose production was calculated during OFF stimulation period and ON stimulation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00663312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2008.