Hypothalamic-pituitary LesionsPhase 3NCT00306683
Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions
A Phase 3 study testing DIAZOXIDE in people with Hypothalamic-pituitary Lesions and Craniopharyngiomas, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hypothalamic-pituitary Lesions, Craniopharyngiomas
- What is being tested?
- DIAZOXIDE
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2006to Apr 2009
- Phase
- Phase 3
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6 to 18 years
- Obesity with body mass index > 97 percentile or > 2 SD
- Hypothalamic-pituitary lesions not evolutive
- Hyperinsulinemia defined by insulin peak after oral glucose tolerance test>100 UI/L
- Absence of diabetes mellitus defined by basal plasma glucose < 1.2 g/L and glucose peak after oral glucose tolerance test < 2 g/L and HbA1c < 7 %
- Hormonal replacement therapy stable from at least three months excluding the treatment of diabetes insipidus which can be adjusted
- Normal plasma thyroxine
- Written informed consent of the children and the parents
Who cannot join
- evolutive lesion
- recent surgery or radiotherapy (< 6 months)
- modification of hormonal replacement therapy during the three previous months
- diabetes mellitus defined by basal plasma glucose > 1.2 g/L and glucose peak after oral glucose tolerance test > 2 g/L and HbA1c > 7 %
- renal or hepatic failure
- uncontrolled hypertension
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- hypersensitivity to benzothiazine drugs
- pregnancy
- difficulties to understand the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions
In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas
Read the detailed description
Approximately 80 % of the hypothalamic-pituitary lesions that occur in children are craniopharyngiomas with one or three cases per 1 million children each year.
One major problem remains unsolved : the obesity
This study is performed to optimize the management of the children with hypothalamic-pituitary lesions by reducing the hyperinsulinemia due to the lesion and the surgery
- Conditions
- Hypothalamic-pituitary Lesions, Craniopharyngiomas
- Being tested
- DIAZOXIDE
- Keywords
- Hypothalamic-pituitary lesions, Craniopharyngioma, Obesity, Diazoxide, Hyperinsulinemia, Pediatric neurosurgery, Oncology, Pituitary, Hypothalamus
- Medical subject headings
- Craniopharyngioma, Obesity, Hyperinsulinism, Neoplasms, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAZOXIDEDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative weight change over two months
Relative weight change over two months
Measured: 2 months
(Weight at Day 1 - Weight at Day 60)/Weight at Day 1
Secondary outcomes (4)
Absolute weight change over two months
Decrease of hyperinsulinemia
Decrease of the glucose peak after oral glucose tolerance test (OGTT)
Evolution of HbA1c
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2009
- Study completionApr 2009
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 Hypothalamic-pituitary LesionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Raja BRAUNER, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306683
- Sponsor's protocol ID
- P040701
- Status last verified
- Apr 2007
- First submitted
- 23 Mar 2006
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brauner R, Serreau R, Souberbielle JC, Pouillot M, Grouazel S, Recasens C, Zerah M, Sainte-Rose C, Treluyer JM. Diazoxide in Children With Obesity After Hypothalamic-Pituitary Lesions: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2016 Dec;101(12):4825-4833. doi: 10.1210/jc.2016-2126. Epub 2016 Sep 7.
PubMed 27603903
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions
- ClinicalTrials.gov ID
- NCT00306683
- Acronym / sponsor ID
- P040701
- Conditions
- Hypothalamic-pituitary Lesions, Craniopharyngiomas
- Keywords
- Hypothalamic-pituitary lesions, Craniopharyngioma, Obesity, Diazoxide, Hyperinsulinemia, Pediatric neurosurgery, Oncology, Pituitary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 24 Mar 2006 (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.
In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas
Detailed description
Approximately 80 % of the hypothalamic-pituitary lesions that occur in children are craniopharyngiomas with one or three cases per 1 million children each year.
One major problem remains unsolved : the obesity
This study is performed to optimize the management of the children with hypothalamic-pituitary lesions by reducing the hyperinsulinemia due to the lesion and the surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 6 to 18 years
- Obesity with body mass index > 97 percentile or > 2 SD
- Hypothalamic-pituitary lesions not evolutive
- Hyperinsulinemia defined by insulin peak after oral glucose tolerance test>100 UI/L
- Absence of diabetes mellitus defined by basal plasma glucose < 1.2 g/L and glucose peak after oral glucose tolerance test < 2 g/L and HbA1c < 7 %
Key exclusion criteria (9 listed)
- evolutive lesion
- recent surgery or radiotherapy (< 6 months)
- modification of hormonal replacement therapy during the three previous months
- diabetes mellitus defined by basal plasma glucose > 1.2 g/L and glucose peak after oral glucose tolerance test > 2 g/L and HbA1c > 7 %
- renal or hepatic failure
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 |
|---|---|---|
| DIAZOXIDE | Drug | – |
Primary outcome
Relative weight change over two months
Time frame: 2 months
Relative weight change over two months
(Weight at Day 1 - Weight at Day 60)/Weight at Day 1
4 secondary outcomes
Absolute weight change over two months
Decrease of hyperinsulinemia
Decrease of the glucose peak after oral glucose tolerance test (OGTT)
Evolution of HbA1c
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
- Derived from this study: PubMed 27603903Brauner R, Serreau R, Souberbielle JC, Pouillot M, Grouazel S, Recasens C, Zerah M, Sainte-Rose C, Treluyer JM. Diazoxide in Children With Obesity After Hypothalamic-Pituitary Lesions: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2016 Dec;101(12):4825-4833. doi: 10.1210/jc.2016-2126. Epub 2016 Sep 7.
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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.
Raja BRAUNER, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DIAZOXIDE in people with Hypothalamic-pituitary Lesions and Craniopharyngiomas, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 18 Feb 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative weight change over two months (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT00306683, 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 18 Feb 2011.