MR Imaging of Fat Deposition in Adolescents With First Time Antipsychotic Use

Study Overview
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Brief Summary
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This study will focus on a population of antipsychotic (AP) naïve adolescents and young adults and will measure fat accumulation in relation to exposure to atypical antipsychotic medications.

Detailed Description
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Atypical Antipsychotics (AAPs) are known to cause metabolic dysfunction, and adolescents are especially vulnerable to this effect. The anthropometric measures routinely used to monitor these metabolic side effects may, in fact, underestimate risk in the pediatric population as they are not a good index of hepatic and visceral adipose tissue. This study will measure fat accumulation over a 12 week period in adolescents and young adults taking an AAP for the first time. MRI imaging will measure hepatic, and visceral adipose tissue at baseline and study end. An Oral Glucose Tolerance Test will measure glucose resistance and insulin sensitivity. In an exploratory fashion, investigators will also image the brain to assess for volumetric changes which may occur in association with AAP treatment and changes in metabolic indices.

Official Title
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MR Imaging of Fat Deposition in Adolescents With First Time Antipsychotic Use

Conditions
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Adiposity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AP naïve or AP-free for 3 months or greater prescribed an AP for treatment age 12-35 using contraceptive (females of child bearing age) Exclusion Criteria: currently taking AP or been taking AP for greater than 1 week within the past 3 months pregnant or planning to become pregnant eating disorder (active or previous) clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease major medical or surgical event in the preceding 3 months acute suicidal risk

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AP Naive<br>Group followed over 12 weeks to measure fat deposition, insulin resistance, and glucose tolerance. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hepatic and visceral adipose tissue from baseline to 3 months | Adipose tissue is measured by an MRI. Fat content will be compared between baseline and study end (3 months). | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose tolerance from baseline to 3 months. | An Oral Glucose Tolerance Test (OGTT) will measure these outcomes at baseline and study end (3 months). Glucose is measured fasting (mmol/L) at the start of the OGTT and then 2 hours post glucose drink. | Baseline and 3 months | 
| Change in insulin sensitivity from baseline to 3 months. | An Oral Glucose Tolerance Test (OGTT) will measure these outcomes at baseline and study end (3 months). Insulin is measured fasting (pmol/L) at the start of the OGTT and then 2 hours post glucose drink. | Baseline and 3 months | 
| Body Mass Index (BMI) | BMI in kg/m^2 | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| Change in appetite | Visual analog scale | Baseline and 3 months | 
| Change in weight | Weight in kilograms | Baseline, 4 weeks, 8 weeks, 12 weeks |