MR Imaging of Fat Deposition in Adolescents With First Time Antipsychotic Use
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5T1R8
- Centre for Addiction and Mental Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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AP Naive
Group followed over 12 weeks to measure fat deposition, insulin resistance, and glucose tolerance.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in hepatic and visceral adipose tissue from baseline to 3 months
기간: Baseline and 3 months
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Adipose tissue is measured by an MRI.
Fat content will be compared between baseline and study end (3 months).
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Baseline and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in glucose tolerance from baseline to 3 months.
기간: Baseline and 3 months
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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.
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Baseline and 3 months
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Change in insulin sensitivity from baseline to 3 months.
기간: Baseline and 3 months
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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.
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Baseline and 3 months
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Body Mass Index (BMI)
기간: Baseline, 4 weeks, 8 weeks, 12 weeks
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BMI in kg/m^2
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Baseline, 4 weeks, 8 weeks, 12 weeks
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Change in appetite
기간: Baseline and 3 months
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Visual analog scale
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Baseline and 3 months
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Change in weight
기간: Baseline, 4 weeks, 8 weeks, 12 weeks
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Weight in kilograms
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Baseline, 4 weeks, 8 weeks, 12 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quality of life
기간: Baseline and 3 months
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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.
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Baseline and 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Margaret Hahn, MD, PhD, Centre for Addiction and Mental Health
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .