- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04098549
The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes (RaSlo-19)
2020년 6월 24일 업데이트: Steno Diabetes Center Copenhagen
In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential.
Previously, a number of potential influencing factors of hepatic glucose production have been investigated, including insulin-on-board, low carbohydrate diet, preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production.
Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of fall in blood glucose influences the following stimulation of hepatic glucose response.
However, the rate of fall in blood glucose is highly related to insulin levels, which may explain those findings.
Thus, in this study the investigators want to examine whether the different rates of fall in blood glucose with similar insulin levels on board affect the hepatic glucose response in individuals with type 1 diabetes.
In the study, which will be conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits.
On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose production will be stimulated using low-dose glucagon.
The study days are divided into four phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and 4) post-glucagon administration phase.
This design will allow the investigators to examine whether differences in hepatic glucose response exist depending on preceding rate of fall in blood glucose.
We hypothesize that the rate of fall in blood glucose does not affect the hepatic glucose production.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
10
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Gentofte, 덴마크, 2820
- Steno Diabetes Center Copenhagen
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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, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age 18-70 years
- Duration of Type 1 Diabetes ≥ 3 years
- Insulin pump use > 6 months
Exclusion Criteria:
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- Allergy or intolerance to lactose or GlucaGen (Novo Nordisk, Bagsværd, DK)
- Use of medications that are known to cause QT interval prolongation
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Females who have different basal insulin pattern depending on their menstrual cycle
- Inability to understand the individual information and to give informed consent
- Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Rapid-Slow
This arm will begin with intervention "rapid" (rapid rate of fall in plasma glucose) for the first study visit and proceed to intervention "slow" (slow rate of fall in plasma glucose) for the second study visit.
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Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique
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실험적: Slow-Rapid
This arm will begin with intervention "slow" (slow rate of fall in plasma glucose) for the first study visit and proceed to intervention "rapid" (rapid rate of fall in plasma glucose) for the second study visit.
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Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Positive incremental area under the glucose curve (PI-AUC) (using the plasma glucose concentration before glucagon administration as basal level)
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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2차 결과 측정
결과 측정 |
기간 |
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Total area under the glucose curve (AUC)
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Peak plasma glucose
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Incremental plasma glucose peak
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Time-to-peak plasma glucose
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Plasma glucose level
기간: 120 minutes after glucagon administration
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120 minutes after glucagon administration
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Duration of plasma glucose above 4.0 mmol/l
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of plasma glucose above baseline
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Number of subjects who, after reaching a plasma glucose value > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-10 mmol/l
기간: throughout phase 4 (until 120 minutes after glucagon administration)
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throughout phase 4 (until 120 minutes after glucagon administration)
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Number of subjects who, after reaching a PG > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-7.8 mmol/l
기간: throughout phase 4 (until 120 minutes after glucagon administration)
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throughout phase 4 (until 120 minutes after glucagon administration)
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Time from glucagon administration to reaching a plasma glucose level > 3,9 mmol/l
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of a plasma glucose level in the range of 3.9-10 mmol/l
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of a plasma glucose level in the range of 3.9-7.8 mmol/l
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Change in insulin levels (measured as area under the curve)
기간: 0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Change in insulin levels (measured as peak change)
기간: from baseline to 120 minutes after glucagon administration
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from baseline to 120 minutes after glucagon administration
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Change in glucagon levels (measured as area under the curve)
기간: 0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Change in glucagon levels (measured as peak change)
기간: 0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Average changes in Edinburgh Hypoglycemia Scale
기간: measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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Average change in visual analogue scale score for nausea, headache, stomach ache and palpitations
기간: measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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Number of subjects experiencing vomiting
기간: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2019년 9월 12일
기본 완료 (실제)
2020년 1월 15일
연구 완료 (실제)
2020년 1월 15일
연구 등록 날짜
최초 제출
2019년 9월 11일
QC 기준을 충족하는 최초 제출
2019년 9월 20일
처음 게시됨 (실제)
2019년 9월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 6월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 6월 24일
마지막으로 확인됨
2020년 6월 1일
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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