- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01856790
Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 초기 1단계
연락처 및 위치
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age 18-40 years
- clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required)
- duration of T1D ≥ 1 year
- HbA1c ≤ 9 %
- Treated with CSII for at least 3 months
- Body weight > 50 kg (to accommodate phlebotomy)
- Be in good general health without other medical or psychiatric illnesses that would, in the judgment of the investigator, interfere with subject safety or study conduct
Exclusion Criteria:
- Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission to the hospital research unit (HRU). Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
- History of hypoglycemic seizure within last 3 months
- Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests.
- Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
- History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility
- Taking a medication known to affect gastric motility
- History of pancreatitis, gallstones, alcoholism or high triglyceride levels
- Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
- Subjects unable to give consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Closed Loop Insulin Delivery
Each participant recruited into the study will undergo two inpatient closed loop admissions. The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback. Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period. Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy. |
폐쇄 루프 장치 및 알고리즘으로 제어되는 인슐린 펌프
Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak Post-prandial Venous Glucose Levels
기간: 48 hours
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peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide
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48 hours
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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the Incremental Meal-related Glucose Area Under Curve (AUC)
기간: 5-hour post prandial period after breakfast, lunch, and dinner
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5-hour post prandial period after breakfast, lunch, and dinner
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Mean 24-hour Glucose Levels
기간: 24- hours
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24- hours
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Mean Time to Peak Post-meal Glucose Value
기간: 5- hour postprandial period
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5- hour postprandial period
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Mean Daytime Glucose Levels
기간: 8a.m.-11p.m.
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8a.m.-11p.m.
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Incremental Glucagon Peak
기간: 5 hours
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5 hours
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AUC Plasma Glucagon During MMTT
기간: 2 hours
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2 hours
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Differences in Daily Insulin Requirements
기간: 24 hours
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24 hours
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Prandial Insulin Delivery During Closed Loop Therapy
기간: Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
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Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
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Mean Nocturnal Glucose Levels
기간: 11p.m.-6a.m.
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11p.m.-6a.m.
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jennifer Sherr, MD, PhD, Yale University
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. .
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