Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
2020년 6월 8일 업데이트: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Comparison of Two Carbohydrate Intake Strategies to Improve Glucose Control During Exercise in Adolescents and Adults With Type 1 Diabetes
To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate intake is frequently required.
Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level.
In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise.
Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
연구 개요
연구 유형
중재적
등록 (실제)
37
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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Quebec
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Montreal, Quebec, 캐나다
- Institut de recherches cliniques de Montreal
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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
14년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Males and females ≥ 14 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- Last (less than 3 months) HbA1c ≤ 10%.
- Patients using multiple daily injections with basal-bolus insulin regimen.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Abnormal blood panel and/or anemia.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Full snack given before exercise
A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise
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Participants will be admitted at IRCM at 14:00.
At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
During exercise, capillary glucose levels will be measured every 10 minutes.
At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour.
At 17:30, the participant will be discharged.
Full snack or Distributed snack
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활성 비교기: Distributed snack over exercise period
A snack containing ~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
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Participants will be admitted at IRCM at 14:00.
At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
During exercise, capillary glucose levels will be measured every 10 minutes.
At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour.
At 17:30, the participant will be discharged.
Full snack or Distributed snack
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of time of capillary glucose levels spent between 4-10 mmol/L
기간: This outcome will be measured over 120 minutes
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This time frame corresponds to the exercise period and the 1 hour following it
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This outcome will be measured over 120 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of time of sensor glucose levels spent between 4-10 mmol/L
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Percentage of time of glucose levels spent below 4 mmol/L
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Decrease in glucose levels
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Difference between glucose level at the start of the exercise and the lowest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Increase in glucose level
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Difference between glucose level at the start of the exercise and the highest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Number of participants requiring an oral treatment for hypoglycemia
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Total number of hypoglycemia episodes requiring treatment
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Percentage of time of glucose levels spent above 10 mmol/L
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Mean time (minutes) to the first hypoglycemic event
기간: This outcome will be measured for the exercise period only (60 minutes)
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This outcome will be measured for the exercise period only (60 minutes)
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Mean glucose levels
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Standard deviation of glucose levels
기간: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
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Percentage of time of glucose levels between 4 and 10 mmol/L
기간: From the end of the exercise period to dinner time.
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Dinner time will be up to the patient.
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From the end of the exercise period to dinner time.
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Percentage of time of glucose levels between 4 and 10 mmol/L
기간: From the end of the exercise period to midnight (7.5 hours)
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From the end of the exercise period to midnight (7.5 hours)
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Percentage of time of glucose levels between 4 and 10 mmol/L
기간: From midnight to 6:00 next morning (6 hours)
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From midnight to 6:00 next morning (6 hours)
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Percentage of time of glucose levels between 4 and 10 mmol/L
기간: From the end of the exercise period to 6:00 next morning (13.5 hours)
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From the end of the exercise period to 6:00 next morning (13.5 hours)
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Percentage of time of glucose levels spent below 4 mmol/L
기간: From the end of the exercise period to dinner time
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Dinner time will be up to the patient.
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From the end of the exercise period to dinner time
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Percentage of time of glucose levels spent below 4 mmol/L
기간: From the end of the exercise period to midnight (7.5 hours)
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From the end of the exercise period to midnight (7.5 hours)
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Percentage of time of glucose levels spent below 4 mmol/L
기간: From midnight to 6:00 next morning (6 hours)
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From midnight to 6:00 next morning (6 hours)
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Percentage of time of glucose levels spent below 4 mmol/L
기간: From the end of the exercise period to 6:00 next morning (13.5 hours)
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From the end of the exercise period to 6:00 next morning (13.5 hours)
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Percentage of time of glucose levels spent above 10 mmol/L
기간: From the end of the exercise period to dinner time
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Dinner time will be up to the patient
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From the end of the exercise period to dinner time
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|
Percentage of time of glucose levels spent above 10 mmol/L
기간: From the end of the exercise period to midnight (7.5 hours)
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From the end of the exercise period to midnight (7.5 hours)
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|
Percentage of time of glucose levels spent above 10 mmol/L
기간: From midnight to 6:00 next morning (6 hours)
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From midnight to 6:00 next morning (6 hours)
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|
Percentage of time of glucose levels spent above 10 mmol/L
기간: From the end of the exercise period to 6:00 next morning (13.5 hours)
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From the end of the exercise period to 6:00 next morning (13.5 hours)
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Number of participants requiring treatment for hypoglycemia
기간: From the end of the exercise period to dinner time
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Dinner time will be up to the patient
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From the end of the exercise period to dinner time
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|
Number of participants requiring treatment for hypoglycemia
기간: From the end of the exercise period to midnight (7.5 hours)
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From the end of the exercise period to midnight (7.5 hours)
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|
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Number of participants requiring treatment for hypoglycemia
기간: From midnight to 6:00 next morning (6 hours)
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From midnight to 6:00 next morning (6 hours)
|
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|
Number of participants requiring treatment for hypoglycemia
기간: From the end of the exercise period to 6:00 next morning (13.5 hours)
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From the end of the exercise period to 6:00 next morning (13.5 hours)
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Number of hypoglycemic episodes requiring treatment
기간: From the end of the exercise period to dinner time
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Dinner time will be up to the patient
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From the end of the exercise period to dinner time
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Number of hypoglycemic episodes requiring treatment
기간: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
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|
Number of hypoglycemic episodes requiring treatment
기간: From midnight to 6:00 next morning (6 hours)
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From midnight to 6:00 next morning (6 hours)
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|
Number of hypoglycemic episodes requiring treatment
기간: From the end of the exercise period to 6:00 next morning (13.5 hours)
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From the end of the exercise period to 6:00 next morning (13.5 hours)
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Mean glucose levels
기간: From the end of the exercise period to dinner time
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Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Mean glucose levels
기간: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Mean glucose levels
기간: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
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|
|
Mean glucose levels
기간: From the end of the exercise period to 6:00 next morning (13.5 hours)
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From the end of the exercise period to 6:00 next morning (13.5 hours)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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)
2017년 8월 3일
기본 완료 (실제)
2019년 8월 2일
연구 완료 (실제)
2019년 8월 2일
연구 등록 날짜
최초 제출
2017년 7월 6일
QC 기준을 충족하는 최초 제출
2017년 7월 10일
처음 게시됨 (실제)
2017년 7월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 6월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 6월 8일
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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