Insulin ResistanceNCT00625170
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans
A study testing olanzapine and Haloperidol in people with Insulin Resistance and Dyslipidemia, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
We hypothesized that short-term treatment with AP drugs induces insulin resistance through a mechanistic route that is independent of weight gain and that atypical drugs exert stronger effects than typical compounds in this respect. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Dyslipidemia
- What is being tested?
- olanzapine and Haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2004to Dec 2004
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men, with and without a positive family history of schizophrenia.
- 20 kg/m2 < BMI < 26 kg/m2
- Age 20-40 years
- Fasting plasma glucose < 6 mmo/L
Who cannot join
- FPG > 6 mmol/L
- BMI > 26 kg/m2
- Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
- Any significant chronic disease
- Renal, hepatic or endocrine disease
- Use of medication known to influence lipolysis and/or glucose metabolism
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- Total cholesterol > 7mmol/L and/or triglycerides > 2 mmol/L
- Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months)
- Difficulties to insert an intravenous catheter
- Smoking (current)
- Severe claustrophobia (ventilated hood)
- Recent blood donation (within the last 2 months)
- Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
- Extensive sporting activities (more than 10 hours of exercise per week)
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesized that short-term treatment with AP drugs induces insulin resistance through a mechanistic route that is independent of weight gain and that atypical drugs exert stronger effects than typical compounds in this respect. We therefore treated healthy non-obese men with olanzapine (atypical AP) or haloperidol (typical AP) for 8 days, and studied the impact of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.
- Conditions
- Insulin Resistance, Dyslipidemia
- Being tested
- olanzapine, Haloperidol
- Keywords
- Antipsychotics, Olanzapine, Haloperidol, Insulin resistance, Dyslipidemia
- Medical subject headings
- Insulin Resistance, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called Zyprexa
olanzapine 10 mg/day for 8 days
HaloperidolDrug
haloperidol 3 mg/day for 8 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Healthy men Receives: Drug: olanzapine |
| 2 | Active comparator | Healthy men with a positive family anamneses of schizophrenia Receives: Drug: olanzapine; Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of subchronic olanzapine and haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startMay 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Investigators
- Hanno Pijl, Phd MD, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625170
- Sponsor's protocol ID
- P03.136
- Status last verified
- Mar 2004
- First submitted
- 19 Feb 2008
- Last updated
- 28 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans
- ClinicalTrials.gov ID
- NCT00625170
- Acronym / sponsor ID
- P03.136
- Conditions
- Insulin Resistance, Dyslipidemia
- Keywords
- Antipsychotics, Olanzapine, Haloperidol, Insulin resistance, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Study start
- May 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 28 Feb 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.
We hypothesized that short-term treatment with AP drugs induces insulin resistance through a mechanistic route that is independent of weight gain and that atypical drugs exert stronger effects than typical compounds in this respect. We therefore treated healthy non-obese men with olanzapine (atypical AP) or haloperidol (typical AP) for 8 days, and studied the impact of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: olanzapineHealthy men |
| 2 | Active comparator | Drug: olanzapine, Drug: HaloperidolHealthy men with a positive family anamneses of schizophrenia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men, with and without a positive family history of schizophrenia.
- 20 kg/m2 < BMI < 26 kg/m2
- Age 20-40 years
- Fasting plasma glucose < 6 mmo/L
Key exclusion criteria (14 listed)
- FPG > 6 mmol/L
- BMI > 26 kg/m2
- Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
- Any significant chronic disease
- Renal, hepatic or endocrine disease
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 |
|---|---|---|
| olanzapineAlso: Zyprexaolanzapine 10 mg/day for 8 days | Drug | 1, 2 |
| Haloperidolhaloperidol 3 mg/day for 8 days | Drug | 2 |
Primary outcome
To determine the effect of subchronic olanzapine and haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation.
Time frame: 8 days
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 28 Feb 2008.
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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.
Hanno Pijl, Phd MD study chair
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olanzapine and Haloperidol in people with Insulin Resistance and Dyslipidemia, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 inclusion and 14 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 28 Feb 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 Netherlands. 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 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?
To determine the effect of subchronic olanzapine and haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation. (time frame: 8 days). It is what the study was designed to measure, not a finding.
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 28 Feb 2008.