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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02744313

Enrollment

Registered

2016-04-20

Start date

2016-04-30

Completion date

2018-04-30

Last updated

2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adiposity

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in glucose tolerance from baseline to 3 months.	Baseline and 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.
Change in insulin sensitivity from baseline to 3 months.	Baseline and 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.
Change in appetite	Baseline and 3 months	Visual analog scale
Change in weight	Baseline, 4 weeks, 8 weeks, 12 weeks	Weight in kilograms
Body Mass Index (BMI)	Baseline, 4 weeks, 8 weeks, 12 weeks	BMI in kg/m\^2

Other

Measure	Time frame	Description
Quality of life	Baseline and 3 months	Assessed with the Pediatric Quality of Life (PedsQL) self-report questionnaire. Items are rated from 1 to 5, with a score of 5 indicating higher levels of quality of life.

Countries

Canada

Outcome results