AlcoholismNCT00447785
Endocrine Regulation of Energy and Fluid Supplies in Alcoholic Patients
An observational study of Alcoholism, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study is about the endocrine regulation of energy and fluid supplies in alcoholic patients. A large proportion of energy and fluid is supplied by alcohol beverages in alcoholic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2004to not given
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Alcoholic patients still under the effect of alcohol at entry
Who cannot join
- Other type of addiction
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires St Luc
Brussels, 1200
de Timary Philippe, MD, PhD, 003227642038, Philippe.detimary@clin.ucl.ac.be
de Timary Philippe, MD, PhD
About this study
Official title: Etude Des déterminants Endocrinologiques Des Apports énergétiques et Fluides Des Patients Alcooliques en Cours de Sevrage
This study is about the endocrine regulation of energy and fluid supplies in alcoholic patients. A large proportion of energy and fluid is supplied by alcohol beverages in alcoholic patients. In this study, we evaluated the importance of these supplies with a detailed questionnaire, a nutrition software that evaluated the importance of each macro- and micronutrients and correlated these values with several hormones such as Leptin, Insulin, Cortisol, Ghrelin, and PYY involved in the regulation of energy balance or AVP involved in the regulation of plasma osmolality
Read the detailed description
This study was conducted in a stepwise manner : study of the energy supplies first, of water supplies next.
Interviews and samples were performed or collected at two times of alcohol withdrawal to evaluate the possibility of parallel changes in craving for alcohol, supplies and endocrine function.
- Conditions
- Alcoholism
- Keywords
- alcoholism, nutrition, craving, energy supplies, water supplies
- Medical subject headings
- Alcoholism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Roussaux Jean Paul, MD, PhD, Study chair, Cliniques Universitaires St Luc, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447785
- Sponsor's protocol ID
- nutrialcohol
- Status last verified
- Mar 2007
- First submitted
- 14 Mar 2007
- Last updated
- 15 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Des déterminants Endocrinologiques Des Apports énergétiques et Fluides Des Patients Alcooliques en Cours de Sevrage
- ClinicalTrials.gov ID
- NCT00447785
- Acronym / sponsor ID
- nutrialcohol
- Conditions
- Alcoholism
- Keywords
- alcoholism, nutrition, craving, energy supplies, water supplies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2004
- First posted
- 15 Mar 2007 (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.
This study is about the endocrine regulation of energy and fluid supplies in alcoholic patients. A large proportion of energy and fluid is supplied by alcohol beverages in alcoholic patients. In this study, we evaluated the importance of these supplies with a detailed questionnaire, a nutrition software that evaluated the importance of each macro- and micronutrients and correlated these values with several hormones such as Leptin, Insulin, Cortisol, Ghrelin, and PYY involved in the regulation of energy balance or AVP involved in the regulation of plasma osmolality
Detailed description
This study was conducted in a stepwise manner : study of the energy supplies first, of water supplies next.
Interviews and samples were performed or collected at two times of alcohol withdrawal to evaluate the possibility of parallel changes in craving for alcohol, supplies and endocrine function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alcoholic patients still under the effect of alcohol at entry
Key exclusion criteria (1 listed)
- Other type of addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2007.
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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.
Roussaux Jean Paul, MD, PhD study chair
Cliniques Universitaires St Luc, Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 2007. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact de Timary Philippe, MD, PhD (003227642038, philippe.detimary@clin.ucl.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 15 Mar 2007.