SchizophreniaNCT01160991
Effect of Atypical Antipsychotic Drugs Olanzapine and Amisulpride on Glucose Metabolism
A study testing Glucose clamp technique, Amisulpride and Olanzapine in people with Schizophrenia and Diabetes, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
Patients suffering from schizophrenia have a high risk to become obese and develop diabetes. Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine or olanzapine. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Diabetes, Insulin Resistance
- What is being tested?
- Glucose clamp technique, Amisulpride and Olanzapine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- May 2004to Oct 2006
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male volunteers
- written informed consent
Who cannot join
- BMI > 30 kg/m²
- Diabetes mellitus
- Hypertension
- Treatment with drugs interfering with lipid or glucose metabolism (e.g. statins, oral antidiabetic drugs, glucocorticoids)
- History of seizures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Serotonin 2A Receptor on Insulin Sensitivity and Secretion: a Double-blind Controlled Comparison of Olanzapine vs. Amisulpride:
Patients suffering from schizophrenia have a high risk to become obese and develop diabetes. Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine or olanzapine. These drugs are called atypical drugs and exert their action in part by occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may also interfere with glucose metabolism and insulin action. The purpose of this study is to compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of placebo on separate days. Then, a combined glucose clamp study will be performed in order to test the effects of these drugs on insulin sensitivity and insulin secretion.
Read the detailed description
10 male healthy volunteers are recruited. After informed consent, they are admitted to the study ward at 10:00 p.m. prior to the study day and kept fasting until the next morning. At 8:00 a.m. they receive their study medication (olanzapine, amisulpride or placebo). Subsequently, measurements of insulin sensitivity and insulin secretion are performed by euglycemic hyperinsulinemic clamp technique followed by hyperglycemic clamp.
- Conditions
- Schizophrenia, Diabetes, Insulin Resistance
- Being tested
- Glucose clamp technique, Amisulpride, Olanzapine, Placebo
- Keywords
- schizophrenia, olanzapine, atypical antipsychotic drugs, amisulpride, diabetes, insulin resistance, insulin secretion, glucose, euglycemic hyperinsulinemic clamp, hyperglycemic clamp
- Medical subject headings
- Schizophrenia, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose clamp techniqueProcedure or surgery
euglycemic hyperinsulinemic clamp with target blood glucose of 90 mg/dl (5 mmol/l), followed by hyperglycemic clamp, target blood glucose of 180 mg/dl (10 mmol/l) for measurement of insulin sensitivity and insulin secretion
AmisulprideDrug
Single dose of amisulpride 200 mg p.o. given at 8:00 a.m.
OlanzapineDrug
Single dose of olanzapine 10 mg p.o. given at 8:00 a.m.
PlaceboDrug
Placebo capsules are given at 8:00 a.m.
| Study group | Role | What they receive |
|---|---|---|
| Amisulpride | Active comparator | Single dose of amisulpride 200 mg p.o. given at 8:00 a.m. Receives: Procedure: Glucose clamp technique; Drug: Amisulpride |
| Olanzapine | Experimental | Single dose of olanzapine 10 mg p.o. given at 8:00 a.m. Receives: Procedure: Glucose clamp technique; Drug: Olanzapine |
| Placebo | Placebo comparator | Placebo capsules are given at 8:00 a.m. Procedures are performed as described above. Receives: Procedure: Glucose clamp technique; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
m-value during euglycemic glucose clamp (glucose infusion rate divided by time and body weight)
Measured: 90 thru 120 min after application of study drug
Secondary outcomes (1)
pancratic c-peptide secretion
C-peptide measured 4 times during hyperglycemic clamp period at time 0 min (prior to glucose bolus), 5 min, 10 min and 60 min after glucose bolus
Measured: 120 thru 180 minutes after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startMay 2004
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Daniel Kopf, M.D., Principal investigator, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160991
- Sponsor's protocol ID
- DeuOlanAmi
- Status last verified
- Aug 2010
- First submitted
- 9 Jul 2010
- Last updated
- 3 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Serotonin 2A Receptor on Insulin Sensitivity and Secretion: a Double-blind Controlled Comparison of Olanzapine vs. Amisulpride:
- ClinicalTrials.gov ID
- NCT01160991
- Acronym / sponsor ID
- DeuOlanAmi
- Conditions
- Schizophrenia, Diabetes, Insulin Resistance
- Keywords
- schizophrenia, olanzapine, atypical antipsychotic drugs, amisulpride, diabetes, insulin resistance, insulin secretion, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- May 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 13 Jul 2010 (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.
Patients suffering from schizophrenia have a high risk to become obese and develop diabetes. Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine or olanzapine. These drugs are called atypical drugs and exert their action in part by occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may also interfere with glucose metabolism and insulin action. The purpose of this study is to compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of placebo on separate days. Then, a combined glucose clamp study will be performed in order to test the effects of these drugs on insulin sensitivity and insulin secretion.
Detailed description
10 male healthy volunteers are recruited. After informed consent, they are admitted to the study ward at 10:00 p.m. prior to the study day and kept fasting until the next morning. At 8:00 a.m. they receive their study medication (olanzapine, amisulpride or placebo). Subsequently, measurements of insulin sensitivity and insulin secretion are performed by euglycemic hyperinsulinemic clamp technique followed by hyperglycemic clamp.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amisulpride | Active comparator | Procedure: Glucose clamp technique, Drug: AmisulprideSingle dose of amisulpride 200 mg p.o. given at 8:00 a.m. |
| Olanzapine | Experimental | Procedure: Glucose clamp technique, Drug: OlanzapineSingle dose of olanzapine 10 mg p.o. given at 8:00 a.m. |
| Placebo | Placebo comparator | Procedure: Glucose clamp technique, Drug: PlaceboPlacebo capsules are given at 8:00 a.m. Procedures are performed as described above. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy male volunteers
- written informed consent
Key exclusion criteria (5 listed)
- BMI > 30 kg/m²
- Diabetes mellitus
- Hypertension
- Treatment with drugs interfering with lipid or glucose metabolism (e.g. statins, oral antidiabetic drugs, glucocorticoids)
- History of seizures
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 |
|---|---|---|
| Glucose clamp techniqueeuglycemic hyperinsulinemic clamp with target blood glucose of 90 mg/dl (5 mmol/l), followed by hyperglycemic clamp, target blood glucose of 180 mg/dl (10 mmol/l) for measurement of insulin sensitivity and insulin secretion | Procedure or surgery | Amisulpride, Olanzapine, Placebo |
| AmisulprideSingle dose of amisulpride 200 mg p.o. given at 8:00 a.m. | Drug | Amisulpride |
| OlanzapineSingle dose of olanzapine 10 mg p.o. given at 8:00 a.m. | Drug | Olanzapine |
| PlaceboPlacebo capsules are given at 8:00 a.m. | Drug | Placebo |
Primary outcome
insulin sensitivity
Time frame: 90 thru 120 min after application of study drug
m-value during euglycemic glucose clamp (glucose infusion rate divided by time and body weight)
1 secondary outcome
pancratic c-peptide secretion
Time frame: 120 thru 180 minutes after administration of study drug
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 3 Aug 2010.
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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.
Daniel Kopf, M.D. principal investigator
Central Institute of Mental Health, Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose clamp technique, Amisulpride and Olanzapine in people with Schizophrenia and Diabetes, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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 2 inclusion and 5 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 3 Aug 2010. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
insulin sensitivity (time frame: 90 thru 120 min after application of study drug). 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 3 Aug 2010.