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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 below

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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:

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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