Insulin ResistanceNCT00363181
Side Effects of Antipsychotic Medications
An observational study of Insulin Resistance and Metabolic Syndrome X, run by Stanford University at 1 site in United States.
Trial summary
Medications like olanzapine have been associated with the development of weight gain and diabetes in some patients. It is not known if the increased risk of developing diabetes is a direct effect on insulin or simply related to weight gain. Read more about this study
- Who is it for?
- Ages 30 to 66 years
- Conditions the study is for
- Insulin Resistance, Metabolic Syndrome X, Schizophrenia and Disorders With Psychotic Features
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2011
- 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 30 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 30-66 years of age
- Body mass index (BMI) >25 < 35 kg/m2.
- Fasting plasma glucose concentration < 126 mg/dL
- Stable on one of the following psychiatric medication: Olanzapine (Zyprexa®), Ziprasidone (Geodon®), Aripiprazole (Abilify®), or Risperidone (Risperdal®)
- Stable on psychiatric medication for at least 3 months
Who cannot join
- Medications that directly affect insulin-mediated glucose disposal
- Intense suicidal impulses/intent
- Alcohol or substance abuse for 3 months.
- Major medical problems, i.e., clinically unstable medical disorder or condition; cardiovascular, hepatic, renal, gastrointestinal, pulmonary, endocrine or other systemic disease that would, in the investigator's clinical judgment interfere with the endocrine measures obtained in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
About this study
Official title: Does Olanzapine Inhibit the Secretory Response to Insulin Resistance?
Medications like olanzapine have been associated with the development of weight gain and diabetes in some patients. It is not known if the increased risk of developing diabetes is a direct effect on insulin or simply related to weight gain.
We hope to learn in this study whether or not olanzapine directly slows down insulin secretion from the pancreas, thereby increasing the risk of developing diabetes.
Read the detailed description
Objectives: The use of atypical antipsychotics has been associated with increased weight gain, the development of type-2 diabetes, and, in rare cases, diabetic ketoacidosis. It is not clear if these changes are a direct function of antipsychotics on either insulin action or insulin secretion, or simply related to their ability to induce weight gain in a population at increased risk to develop hyperglycemia. The objective of this investigation is to determine if treatment with the atypical antipsychotics olanzapine impairs the ability of the pancreatic beta cell to increase its insulin secretory response to graded increases in plasma glucose concentration in non-diabetic, insulin resistant individuals. In addition, we will compare the range of insulin-mediated glucose uptake (IMGU) in olanzapine-treated versus non-antipsychotic treated patients.
Research Plan and Methods: 120 subjects with psychiatric disorders will be enrolled; 60 patients on olanzapine and 60 patients with similar psychiatric diagnoses on a different antipsychotic medication (ziprasidone, risperidone or aripiprazole). All subjects will have a fasting plasma glucose concentration <126 mg/dL, and on no medication with a direct effect on IMGU. Subjects will be admitted to the General Clinical Research Center (GCRC) at Stanford Medical Center and evaluated by an insulin suppression test (IST) to determine their IMGU. Subjects with a steady state plasma glucose (SSPG) concentration during the IST that is >180 mg/dL will be defined as being insulin resistant. From this population of subjects, 15 patients on olanzapine and 15 patients not on any antipsychotic, will return to the GCRC to determine their glucose-stimulated insulin secretory dose-response curves (GS-ISR). The GS-ISR at the same glucose concentration will be compared between the subjects on olanzapine (n=15) and the not on an antipsychotic (n=15) by analysis of variance. Analyses of the 120 subjects screened for insulin resistance will compare 1) the means and distribution of the SSPG concentrations in olanzapine and non-olanzapine treated patients with psychiatric diagnoses; and 2) the means of the two experimental groups with psychiatric diagnoses to Dr. Reaven's data base of volunteers without psychiatric disorders.
- Conditions
- Insulin Resistance, Metabolic Syndrome X, Schizophrenia and Disorders With Psychotic Features, Mood Disorders, Psychotic Disorders
- Keywords
- Insulin resistance, Metabolic problems, Weight gain, Mental health problems, Mental disorders, Antipsychotic medication, Olanzapine
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome, Schizophrenia Spectrum and Other Psychotic Disorders, Mood Disorders, Psychotic Disorders, Weight Gain, Mental Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2011
- Study completionDec 2011
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 Stanford UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven E Lindley, MD, PhD, Principal investigator, Stanford School of Medicine / VA Palo AltoGerald M Reaven, MD, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363181
- Sponsor's protocol ID
- F1DMC-X280
- Status last verified
- Mar 2021
- First submitted
- 9 Aug 2006
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Olanzapine Inhibit the Secretory Response to Insulin Resistance?
- ClinicalTrials.gov ID
- NCT00363181
- Acronym / sponsor ID
- F1DMC-X280
- Conditions
- Insulin Resistance, Metabolic Syndrome X, Schizophrenia and Disorders With Psychotic Features, Mood Disorders, Psychotic Disorders
- Keywords
- Insulin resistance, Metabolic problems, Weight gain, Mental health problems, Mental disorders, Antipsychotic medication, Olanzapine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2006 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Aug 2006 (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.
Medications like olanzapine have been associated with the development of weight gain and diabetes in some patients. It is not known if the increased risk of developing diabetes is a direct effect on insulin or simply related to weight gain.
We hope to learn in this study whether or not olanzapine directly slows down insulin secretion from the pancreas, thereby increasing the risk of developing diabetes.
Detailed description
Objectives: The use of atypical antipsychotics has been associated with increased weight gain, the development of type-2 diabetes, and, in rare cases, diabetic ketoacidosis. It is not clear if these changes are a direct function of antipsychotics on either insulin action or insulin secretion, or simply related to their ability to induce weight gain in a population at increased risk to develop hyperglycemia. The objective of this investigation is to determine if treatment with the atypical antipsychotics olanzapine impairs the ability of the pancreatic beta cell to increase its insulin secretory response to graded increases in plasma glucose concentration in non-diabetic, insulin resistant individuals. In addition, we will compare the range of insulin-mediated glucose uptake (IMGU) in olanzapine-treated versus non-antipsychotic treated patients.
Research Plan and Methods: 120 subjects with psychiatric disorders will be enrolled; 60 patients on olanzapine and 60 patients with similar psychiatric diagnoses on a different antipsychotic medication (ziprasidone, risperidone or aripiprazole). All subjects will have a fasting plasma glucose concentration <126 mg/dL, and on no medication with a direct effect on IMGU. Subjects will be admitted to the General Clinical Research Center (GCRC) at Stanford Medical Center and evaluated by an insulin suppression test (IST) to determine their IMGU. Subjects with a steady state plasma glucose (SSPG) concentration during the IST that is >180 mg/dL will be defined as being insulin resistant. From this population of subjects, 15 patients on olanzapine and 15 patients not on any antipsychotic, will return to the GCRC to determine their glucose-stimulated insulin secretory dose-response curves (GS-ISR). The GS-ISR at the same glucose concentration will be compared between the subjects on olanzapine (n=15) and the not on an antipsychotic (n=15) by analysis of variance. Analyses of the 120 subjects screened for insulin resistance will compare 1) the means and distribution of the SSPG concentrations in olanzapine and non-olanzapine treated patients with psychiatric diagnoses; and 2) the means of the two experimental groups with psychiatric diagnoses to Dr. Reaven's data base of volunteers without psychiatric disorders.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants 30-66 years of age
- Body mass index (BMI) >25 < 35 kg/m2.
- Fasting plasma glucose concentration < 126 mg/dL
- Stable on one of the following psychiatric medication: Olanzapine (Zyprexa®), Ziprasidone (Geodon®), Aripiprazole (Abilify®), or Risperidone (Risperdal®)
- Stable on psychiatric medication for at least 3 months
Key exclusion criteria (4 listed)
- Medications that directly affect insulin-mediated glucose disposal
- Intense suicidal impulses/intent
- Alcohol or substance abuse for 3 months.
- Major medical problems, i.e., clinically unstable medical disorder or condition; cardiovascular, hepatic, renal, gastrointestinal, pulmonary, endocrine or other systemic disease that would, in the investigator's clinical judgment interfere with the endocrine measures obtained in this study.
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
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 22 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Steven E Lindley, MD, PhD principal investigator
Stanford School of Medicine / VA Palo Alto
Gerald M Reaven, MD principal investigator
Stanford School of Medicine
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 Insulin Resistance and Metabolic Syndrome X, run by Stanford University 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 5 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 22 Mar 2021. 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. 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.
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 22 Mar 2021.