- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02734238
심각한 에너지 결핍 및 회복 시 테스토스테론의 생리적, 심리적 영향 (OPS)
2019년 1월 3일 업데이트: Jennifer C. Rood, Pennington Biomedical Research Center
심각한 에너지 결핍 및 회복 동안 테스토스테론의 생리학적 및 심리적 영향: 무작위, 위약 대조 시험
이 연구의 목적은 심각하고 지속적인 에너지 결핍 동안 eugonadal 상태를 유지하는 것이 생리적 감소, 특히 제 지방량의 손실을 약화시키는지 여부를 결정하는 것입니다.
연구 개요
상세 설명
이 연구는 3단계 무작위 위약 대조 시험에 최대 60명의 신체 활동적인 남성을 등록합니다.
14일(자유 생활, 1단계) 완료 후, 에너지 적정, 식이 적응 단계(단백질, 1.6g∙kg-1∙d-1, 지방 30% 총 에너지 섭취, 나머지 에너지는 탄수화물에서 파생됨) ), 참가자는 두 실험 그룹 중 하나로 무작위 배정되고 28일(실시간, 2단계), 55% 에너지 결핍 단계: 에너지 결핍 단독(DEF) 또는 에너지 결핍 + 외인성 테스토스테론(DEF+TEST)을 겪습니다. .
회복(자유 생활, 3단계)은 2단계를 완료한 후 평가되어 초기 체질량의 ± 2.5% 내에서 체질량이 회복되었는지 결정합니다(기간은 다양하며 3단계의 경우 최대 42일).
이 연구는 생리적 및 심리적 상태의 복잡한 마커에 대한 군사 훈련 및 전투 작전 중에 전투원이 직면하는 신체적 및 정신적 요구로 인한 테스토스테론 감소의 기여도를 기술하여 직접적이고 일관되게 관찰되는 지식 격차를 해결할 것입니다.
연구 유형
중재적
등록 (실제)
53
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Louisiana
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Baton Rouge, Louisiana, 미국, 70808
- Pennington Biomedical Research Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
포함 기준:
- 신체 활동적(주당 최소 2일 유산소 및/또는 저항 운동)
- 연구 의사가 제공/승인하지 않는 한, 처방약을 복용하지 않거나 전체 연구 기간 동안 전체 연구 기간 동안 모든 약물 사용을 자제할 의향이 있음
전체 연구 기간 동안 알코올, 흡연, 전자 담배 또는 니코틴 제품 사용, 카페인 및 건강 보조 식품 사용을 자제할 의향이 있는 자
- 연구 의사의 재량에 따라 약물, 보충제 및 일반 의약품에 대한 휴약 기간은 ≥ 1~4주입니다.
- 카페인과 알코올의 워시아웃 기간은 ≥ 7일입니다.
- 연속 28일 동안 Pennington Biomedical Research Center 입원 환자 병동에서 생활할 의향이 있음
- 소변 약물 스크리닝을 기꺼이 받음
- 신장, 체중 및 둘레 측정(목 및 허리)을 기반으로 한 체지방 백분율 추정치를 포함하는 육군 규정 600-9에 따른 연령별 미국 육군 체성분 기준을 충족합니다.
- 총 테스토스테론 농도는 정상적인 생리학적 범위인 총 테스토스테론(300-1,000 ng/dL) 내에 있습니다.
제외 기준:
- 운동 능력을 저하시키는 근골격계 부상
- 심장대사질환(고혈압, 고지혈증, 신장질환, 당뇨병 등)으로 진단된 자
- 음식에 대한 알레르기 또는 과민증, 채식 관행 또는 리도카인 합병증 병력
- 단백 동화 스테로이드, 인간 성장 호르몬 또는 지난 6개월 이내에 영양 테스토스테론 전구체 유사 보충제 사용
- 연구 기간 동안 흡연(니코틴 제품), 알코올, 카페인 또는 기타 식이 보조제를 삼가하지 않을 것입니다.
- 연구 참여 3개월 이내에 국소 항생제를 제외한 모든 항생제 사용
- 연구 참여 3개월 이내 대장내시경 검사
- 완하제, 대변 연화제, 제산제 또는 지사제를 만성적으로 사용(≥ 일주일에 한 번)
- 위장병 병력(예: 셀리악병, 과민성 대장 증후군, 대장염, 크론병)
- 연구의 심리적 및 행동 평가 직원이 평가한 절제된 먹는 사람(3단계 식사 설문지)
- 동의할 수 없는 성인
- 여성
- 죄수
- 금속 임플란트, 밀실 공포증, MRI 장비와 호환되지 않는 머리 크기 등
- 주당 2일 미만의 신체 활동(에어로빅 및/또는 저항 운동)
- 육군 규정 600-9에 따른 연령별 미 육군 체성분 기준 초과
- 의료 조사관이 달리 승인하지 않는 한 신장 결석의 이전 병력
- 수축기 혈압 > 150 또는 이완기 혈압 > 95mmHg
- 유방암 또는 전립선 암의 이전 병력
- 만성 폐쇄성 폐질환 또는 폐쇄성 수면 무호흡증의 과거력
- 전립선특이항원 > 3ng/ml, 헤마토크릿 > 50%, 또는 양성 요약물 선별검사 결과 소견
- 조사팀의 임상적 판단에 따라 피험자는 연구 참여에 적합하지 않을 수 있습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 에너지 부족
제어 조건에 무작위로 배정된 참가자는 운동으로 인한 에너지 소비의 대상이 되어 55%의 에너지 부족을 초래하고 임상 2상 동안 참기름 위약 주사를 투여받게 됩니다.
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매주 15일, 21일, 28일 및 35일에 참기름 200mg 근육 주사
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실험적: 에너지 결핍 + 테스토스테론
중재 조건에 무작위로 배정된 참가자는 운동으로 인한 에너지 소비로 인해 55%의 에너지 부족이 발생하고 임상 2상 동안 테스토스테론 에난테이트 주사를 투여받게 됩니다.
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15일, 21일, 28일 및 35일에 매주 근육 주사로 200 mg 테스토스테론 에난테이트
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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각 연구 단계가 끝날 때 신체 구성
기간: 각 연구 단계 종료: 1상 11일, 2상 39일, 3상 85일까지
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신장은 stadiometer를 사용하여 측정되었습니다.
무게는 보정된 디지털 저울을 사용하여 측정되었습니다.
체성분은 이중 에너지 X선 흡수계측법을 사용하여 결정되었습니다.
이 데이터는 무지방 체질량, 체지방량 및 총 체조직 질량을 계산하는 데 사용되었습니다.
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각 연구 단계 종료: 1상 11일, 2상 39일, 3상 85일까지
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Jennifer C Rood, Ph.D., Pennington Biomedical Research Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 4월 1일
기본 완료 (실제)
2017년 12월 1일
연구 완료 (실제)
2017년 12월 1일
연구 등록 날짜
최초 제출
2016년 3월 31일
QC 기준을 충족하는 최초 제출
2016년 4월 5일
처음 게시됨 (추정)
2016년 4월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 1월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 1월 3일
마지막으로 확인됨
2019년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PBRC 2015-063
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .