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Antipsychotic
Antipsychotics for Insulin Resistance in Females
Toronto, Canada
N/A
Recruiting
Led By Mahavir Agarwal, MBBS, PhD, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 18-35 years
Body Mass Index (BMI) <25 kg/m2
Must not have
Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol/L, HbA1c>6% or use of anti-diabetic drug)
History of kidney or liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visits 1-4 (5-6 months); 2 visits during follicular phase, 2 visits during luteal phase. at each visit, either oral olanzapine or placebo is given. mri #1 occurs after intranasal challenge #1 and mri #2 occurs after intranasal challenge #2.
Summary
This trial seeks to understand how antipsychotic medications may affect brain insulin action in females, especially during different phases of their menstrual cycle. The study will involve giving young healthy females olanzapine
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Who is the study for?
This trial is for young healthy females who may be experiencing insulin resistance, type 2 diabetes, or menstrual irregularities and are not currently on antipsychotics. Participants should be able to undergo MRI scans and have no history of drug abuse, psychiatric disorders, or significant medical conditions.Check my eligibility
What is being tested?
The study tests how the brain's response to insulin in females is affected by their menstrual cycle phase and the use of an antipsychotic called Olanzapine. It involves giving participants intranasal insulin or a placebo during different phases of their menstrual cycle while monitoring changes with MRI.See study design
What are the potential side effects?
Olanzapine can cause weight gain, increased appetite, drowsiness, and sometimes more serious side effects like changes in metabolism. Intranasal insulin has few reported side effects but might include irritation inside the nose.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 35 years old.
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My BMI is less than 25.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have pre-diabetes or diabetes based on my blood sugar levels or I'm taking medication for it.
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I have a history of kidney or liver disease.
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I have not had a major medical or surgical event in the last 6 months.
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I am currently using weight loss medications.
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I am currently using hormone or fertility treatments.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visits 1-4 (5-6 months); 2 visits during follicular phase, 2 visits during luteal phase. at each visit, either oral olanzapine or placebo is given. mri #1 occurs after intranasal challenge #1 and mri #2 occurs after intranasal challenge #2.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visits 1-4 (5-6 months); 2 visits during follicular phase, 2 visits during luteal phase. at each visit, either oral olanzapine or placebo is given. mri #1 occurs after intranasal challenge #1 and mri #2 occurs after intranasal challenge #2.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Resting State Functional Connectivity (assessed through Functional MRI)
Secondary study objectives
Processing Speed
Visuospatial Memory
Trial Design
2Treatment groups
Experimental Treatment
Group I: Luteal Phase VisitsExperimental Treatment4 Interventions
Participants will undergo two visits during the luteal phase of the menstrual cycle (they will be scanned between day 16-22, or within 5 days of next expected menses depending on individual cycle duration). Each of the study periods will involve administration of OLA 5 mg HS (or PL) on day 0, OLA 10 mg HS (or PL) on day 1, and cognitive testing and MRI scanning on day 2. MRI assessments will occur 15 minutes after administering 160 International Units (IU) INI/INP.
Group II: Follicular Phase VisitsExperimental Treatment4 Interventions
Participants will undergo two visits during the follicular phase of the menstrual cycle (they will be scanned between day 4-10 of their menstrual cycle). Each of the study periods will involve administration of OLA 5 mg HS (or PL) on day 0, OLA 10 mg HS (or PL) on day 1, and cognitive testing and MRI scanning on day 2. MRI assessments will occur 15 minutes after administering 160 International Units (IU) INI/INP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline
2013
Completed Phase 4
~2120
Insulin Lispro 100 UNT/ML
2017
Completed Phase 2
~50
Placebo
1995
Completed Phase 3
~2670
Find a Location
Closest Location:Centre for Addiction and Mental Health (CAMH)· Toronto, Canada· 315 miles
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
386 Previous Clinical Trials
84,205 Total Patients Enrolled
1 Trials studying Insulin Resistance
24 Patients Enrolled for Insulin Resistance
Mahavir Agarwal, MBBS, PhD, MDPrincipal InvestigatorCentre for Addiction and Mental Health