Metabolic SyndromeAMMS1NCT00627757
Antipsychotic Medicine and Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Glostrup University Hospital, Copenhagen at 2 sites in Denmark.
Trial summary
The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and a quality of life. The investigators expect, that 30-50% of patients will show pharmacon - gene induced weight gain (> 7% of initial bodyweight) while the rest of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2008to Dec 2010
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Study population: 50 patients and 100 control persons. Patients should be treated with minimum one antipsychotic drug and hospitalized or treated as out-patients at Glostrup, Ballerup or Gentofte hospitals. Controls will be chosen from the database at Institute of Health and Prevention, Glostrup.
Who may be able to join
- gender : male
- age: 18-45
- treatment with minimum one Antipsychotic drug (AP)
- ethnicity: caucasians
- consent given to take part in the project
Who cannot join
- One criteria is sufficient to exclude patients from the study:
- compliance problems
- unable to read, write and talk Danish
- patients with major lung-,heart-, lever- and kidney problems
- patients with diagnose and treatment for Diabetes 1 and 2
- patients taking cholesterol-reducing, weight-reducing and antihypertensive medication
Show all 10Show fewer
- patients with abuse of alcohol or drugs
- patients who are under duress §
- patients who have been mentally ill for more than 15 years
- patients with diagnosis/treatment for NIDDM/IDDM
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Psychiatric University Center Glostrup
Copenhagen, Glostrup, 2600
Henrik Lublin, MD DMSc, 045-43233540, henlub01@glo.regionh.dk
Henrik Lublin, MD DMSc
- Not yet recruiting
Psychiatric University Center Glostrup
Copenhagen, Glostrup, 2600
Henrik Lublin, MD DMSc, 045-43233540, henlub01@glo.regionh.dk
Henrik Lublin, MD DMSc
About this study
Official title: Changes in Enteroendocrine and Neuroendocrine Axes in Patients With Weight Gain After Treatment With Antipsychotics
The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and a quality of life.
The investigators expect, that 30-50% of patients will show pharmacon - gene induced weight gain (> 7% of initial bodyweight) while the rest of patients will maintain unaltered bodyweight.
Read the detailed description
The primary aim of this study is to investigate status of neuro-and enteroendocrine axes with focus on beta - cell function in relation to insulin resistance, lipid profile abnormalities and inflammations adipokins in patients during treatment with antipsychotics (AP) in relation to weight gain.
The second aim is to evaluate the connection between weight gain and patients´ own perception of their quality of life and health.
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, weight gain, antipsychotic drugs, Metabolic syndrome and treatment with antipsychotic drugs
- Medical subject headings
- Metabolic Syndrome, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Food challenge test | Patients 51 patients included | |
| C | Controls 93 healthy controls are included |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010 (estimated)
- Study completionDec 2010 (estimated)
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 Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, University of Copenhagen
- Investigators
- Henrik Lublin, MD DMSc, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627757
- Sponsor's protocol ID
- HC-2007-0069
- Other IDs
- 2602-706
- Acronym
- AMMS1
- Status last verified
- Jul 2010
- First submitted
- 22 Feb 2008
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ebdrup BH, Knop FK, Madsen A, Mortensen HB, Sogaard B, Holst JJ, Szecsi PB, Lublin H. Glucometabolic hormones and cardiovascular risk markers in antipsychotic-treated patients. J Clin Psychiatry. 2014 Sep;75(9):e899-905. doi: 10.4088/JCP.13m08820.
PubMed 25295432
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Enteroendocrine and Neuroendocrine Axes in Patients With Weight Gain After Treatment With Antipsychotics
- ClinicalTrials.gov ID
- NCT00627757
- Acronym / sponsor ID
- AMMS1 / HC-2007-0069
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, weight gain, antipsychotic drugs, Metabolic syndrome and treatment with antipsychotic drugs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, University of Copenhagen
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 3 Mar 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.
The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and a quality of life.
The investigators expect, that 30-50% of patients will show pharmacon - gene induced weight gain (> 7% of initial bodyweight) while the rest of patients will maintain unaltered bodyweight.
Detailed description
The primary aim of this study is to investigate status of neuro-and enteroendocrine axes with focus on beta - cell function in relation to insulin resistance, lipid profile abnormalities and inflammations adipokins in patients during treatment with antipsychotics (AP) in relation to weight gain.
The second aim is to evaluate the connection between weight gain and patients´ own perception of their quality of life and health.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food challenge test | – | –Patients 51 patients included |
| C | – | –Controls 93 healthy controls are included |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 50 patients and 100 control persons. Patients should be treated with minimum one antipsychotic drug and hospitalized or treated as out-patients at Glostrup, Ballerup or Gentofte hospitals. Controls will be chosen from the database at Institute of Health and Prevention, Glostrup.
Key inclusion criteria (5 listed)
- gender : male
- age: 18-45
- treatment with minimum one Antipsychotic drug (AP)
- ethnicity: caucasians
- consent given to take part in the project
Key exclusion criteria (10 listed)
- compliance problems
- unable to read, write and talk Danish
- patients with major lung-,heart-, lever- and kidney problems
- patients with diagnose and treatment for Diabetes 1 and 2
- patients taking cholesterol-reducing, weight-reducing and antihypertensive medication
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 30 Jul 2010.
- Derived from this study: PubMed 25295432Ebdrup BH, Knop FK, Madsen A, Mortensen HB, Sogaard B, Holst JJ, Szecsi PB, Lublin H. Glucometabolic hormones and cardiovascular risk markers in antipsychotic-treated patients. J Clin Psychiatry. 2014 Sep;75(9):e899-905. doi: 10.4088/JCP.13m08820.
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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.
Henrik Lublin, MD DMSc principal investigator
Glostrup University Hospital, Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Glostrup University Hospital, Copenhagen at 2 sites in Denmark.
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 5 inclusion and 10 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 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 Henrik Lublin, MD DMSc (045-43233540, henlub01@glo.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627757, 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 30 Jul 2010.