Insulin ResistanceNCT00741026

A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers

A study testing Olanzapine 10 mg po qhs for 3 days in people with Insulin Resistance and Diabetes Mellitus, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy… Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Insulin Resistance, Diabetes Mellitus
What is being tested?: Olanzapine 10 mg po qhs for 3 days
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Aug 2008to May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Volunteer
Body Mass Index of 18.5-25 kilograms per square meter
Must be able to swallow tablets
Able to give informed consent

Who cannot join

Any DSM-IV TR Axis I psychiatric disorder (except nicotine dependence)
Presence of any medical disorder that may confound the assessment of relevant biologic measures, including: significant organ system dysfunction, metabolic diseases, type 1 diabetes mellitus, type 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, clinically significant anemia, or acute infection
Subjects who have taken any antipsychotic medication within the last 6 months
Personal or family history of seizures and/or cardiac arrhythmias

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: A Double-blind, Placebo-controlled, Crossover Study Examining the Acute Effects of Olanzapine on Plasma Leptin, Glucose Tolerance and Free Fatty Acids in Healthy Volunteers

Conditions: Insulin Resistance, Diabetes Mellitus
Being tested: Olanzapine 10 mg po qhs for 3 days, Placebo
Keywords: Insulin Resistance, Diabetes mellitus, Antipsychotic
Medical subject headings: Insulin Resistance, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Olanzapine 10 mg po qhs for 3 daysDrug
Also called Zyprexa
(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)
PlaceboDrug
Also called Sugar pill
(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)

Study groups in NCT00741026
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo
Olanzapine	Experimental	Olanzapine 10mg po daily x 3 days Receives: Drug: Olanzapine 10 mg po qhs for 3 days

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Leptin
Leptin following placebo or olanzapine treatment
Measured: 3 Days
Oral Glucose Tolerance
Oral Glucose Tolerance
Measured: 3 Days
Plasma Free Fatty Acid
Plasma Free Fatty Acid
Measured: 3 Days

Secondary outcomes (9)

HDL Cholesterol
HDL Cholesterol
Measured: 3 Days
Triglycerides
Triglycerides
Measured: 3 Days
LDL Cholesterol
LDL Cholesterol
Measured: 3 Days
Total Cholesterol
Total Cholesterol
Measured: 3 Days
Body Weight
Body Weight
Measured: 3 Days
BMI
BMI
Measured: 3 Days
Heart Rate
Heart Rate
Measured: 3 Days
Systolic Blood Pressure
Systolic Blood Pressure
Measured: 3 Days
Diastolic Blood Pressure
Diastolic Blood Pressure
Measured: 3 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008May 2011

First posted25 Aug 2008 (estimated)
Study startAug 2008
Primary completionDec 2010
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Insulin ResistanceStudies of the same condition, open and under way.
More trials run by Milton S. Hershey 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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00741026
Sponsor's protocol ID: 28230
Status last verified: Jul 2014
First submitted: 22 Aug 2008
Last updated: 14 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Albaugh VL, Henry CR, Bello NT, Hajnal A, Lynch SL, Halle B, Lynch CJ. Hormonal and metabolic effects of olanzapine and clozapine related to body weight in rodents. Obesity (Silver Spring). 2006 Jan;14(1):36-51. doi: 10.1038/oby.2006.6.
PubMed 16493121
Albaugh VL, Judson JG, She P, Lang CH, Maresca KP, Joyal JL, Lynch CJ. Olanzapine promotes fat accumulation in male rats by decreasing physical activity, repartitioning energy and increasing adipose tissue lipogenesis while impairing lipolysis. Mol Psychiatry. 2011 May;16(5):569-81. doi: 10.1038/mp.2010.33. Epub 2010 Mar 23.
PubMed 20308992
Albaugh VL, Vary TC, Ilkayeva O, Wenner BR, Maresca KP, Joyal JL, Breazeale S, Elich TD, Lang CH, Lynch CJ. Atypical antipsychotics rapidly and inappropriately switch peripheral fuel utilization to lipids, impairing metabolic flexibility in rodents. Schizophr Bull. 2012 Jan;38(1):153-66. doi: 10.1093/schbul/sbq053. Epub 2010 May 21.
PubMed 20494946
Albaugh VL, Singareddy R, Mauger D, Lynch CJ. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers. PLoS One. 2011;6(8):e22662. doi: 10.1371/journal.pone.0022662. Epub 2011 Aug 9.
PubMed 21857944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Crossover Study Examining the Acute Effects of Olanzapine on Plasma Leptin, Glucose Tolerance and Free Fatty Acids in Healthy Volunteers
ClinicalTrials.gov ID: NCT00741026
Acronym / sponsor ID: 28230
Conditions: Insulin Resistance, Diabetes Mellitus
Keywords: Insulin Resistance, Diabetes mellitus, Antipsychotic
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: American Medical Association
Study start: Aug 2008
Primary completion: Dec 2010 (actual)
Study completion: May 2011 (actual)
First posted: 25 Aug 2008 (estimated)
Results: Posted 14 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo
Olanzapine	Experimental	Drug: Olanzapine 10 mg po qhs for 3 daysOlanzapine 10mg po daily x 3 days

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy Volunteer
Body Mass Index of 18.5-25 kilograms per square meter
Must be able to swallow tablets
Able to give informed consent

Key exclusion criteria (4 listed)

Any DSM-IV TR Axis I psychiatric disorder (except nicotine dependence)
Presence of any medical disorder that may confound the assessment of relevant biologic measures, including: significant organ system dysfunction, metabolic diseases, type 1 diabetes mellitus, type 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, clinically significant anemia, or acute infection
Subjects who have taken any antipsychotic medication within the last 6 months
Personal or family history of seizures and/or cardiac arrhythmias

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
Olanzapine 10 mg po qhs for 3 daysAlso: Zyprexa(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)	Drug	Olanzapine
PlaceboAlso: Sugar pill(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)	Drug	Placebo

Primary outcome

Plasma Leptin
Time frame: 3 Days
Leptin following placebo or olanzapine treatment
Oral Glucose Tolerance
Time frame: 3 Days
Oral Glucose Tolerance
Plasma Free Fatty Acid
Time frame: 3 Days
Plasma Free Fatty Acid

9 secondary outcomes

HDL Cholesterol
Time frame: 3 Days
Triglycerides
Time frame: 3 Days
LDL Cholesterol
Time frame: 3 Days
Total Cholesterol
Time frame: 3 Days
Body Weight
Time frame: 3 Days
BMI
Time frame: 3 Days
Heart Rate
Time frame: 3 Days
Systolic Blood Pressure
Time frame: 3 Days
Diastolic Blood Pressure
Time frame: 3 Days

Results and safety

Results posted to the registry on 14 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo / Olanzapine	15	15

Primary outcome: Plasma Leptin

Time frame: 3 Days. Mean (Standard Deviation). Unit: ng/ml

Measure	Placebo n = 15	Olanzapine n = 15
Value	6.8 (1.3)	8.4 (1.7)

Placebo vs Olanzapine: p = 0.0203, Wilcoxon Signed-rank

Primary outcome: Oral Glucose Tolerance

Time frame: 3 Days. Mean (Standard Deviation). Unit: min*mg/dl

Measure	Placebo n = 15	Olanzapine n = 15
Value	2808 (474)	3984 (444)

Placebo vs Olanzapine: p = 0.0105, Wilcoxon Sign-rank

Primary outcome: Plasma Free Fatty Acid

Time frame: 3 Days. Mean (Standard Deviation). Unit: mM

Measure	Placebo n = 15	Olanzapine n = 15
Value	0.38 (0.06)	0.26 (0.04)

Placebo vs Olanzapine: p = 0.0166, Wilcoxon Sign-rank

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 15 (0%)	0 of 15 (0%)	Not reported
Olanzapine	0 of 15 (0%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): One episode of orthostatic hypotension requiring unblinding. One individual with emesis after glucose challenge and that individual's glucose tolerance data were unavailable analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16493121Albaugh VL, Henry CR, Bello NT, Hajnal A, Lynch SL, Halle B, Lynch CJ. Hormonal and metabolic effects of olanzapine and clozapine related to body weight in rodents. Obesity (Silver Spring). 2006 Jan;14(1):36-51. doi: 10.1038/oby.2006.6.
Background: PubMed 20308992Albaugh VL, Judson JG, She P, Lang CH, Maresca KP, Joyal JL, Lynch CJ. Olanzapine promotes fat accumulation in male rats by decreasing physical activity, repartitioning energy and increasing adipose tissue lipogenesis while impairing lipolysis. Mol Psychiatry. 2011 May;16(5):569-81. doi: 10.1038/mp.2010.33. Epub 2010 Mar 23.
Background: PubMed 20494946Albaugh VL, Vary TC, Ilkayeva O, Wenner BR, Maresca KP, Joyal JL, Breazeale S, Elich TD, Lang CH, Lynch CJ. Atypical antipsychotics rapidly and inappropriately switch peripheral fuel utilization to lipids, impairing metabolic flexibility in rodents. Schizophr Bull. 2012 Jan;38(1):153-66. doi: 10.1093/schbul/sbq053. Epub 2010 May 21.
Results publication: PubMed 21857944Albaugh VL, Singareddy R, Mauger D, Lynch CJ. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers. PLoS One. 2011;6(8):e22662. doi: 10.1371/journal.pone.0022662. Epub 2011 Aug 9.

Related trials for Insulin Resistance

Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
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Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
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Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
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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.

Ravi Singareddy, M.D. study director

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Vance L Albaugh, M.D., Ph.D. principal investigator

Penn State College of Medicine

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 10 mg po qhs for 3 days in people with Insulin Resistance and Diabetes Mellitus, run by Milton S. Hershey Medical Center at 1 site in United States.

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 4 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 14 Jul 2014. 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 United States. 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?

Yes. Results are posted in the registry (first posted 14 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Plasma Leptin (time frame: 3 Days). The study lists 3 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 NCT00741026, which also lists 4 linked publications.

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 14 Jul 2014.