HIT on Hypoglycaemic Risk in T1D
Can High Intensity Interval Training Reduce Fear of Hypoglycaemia and Improve Glycaemic Control in People With Type 1 Diabetes?
There is clear evidence that regular exercise improves wellbeing and reduces the risk of diabetes related complications in people with type 1 diabetes. However, many people with type 1 diabetes do not exercise regularly. The primary reason for this is fear of hypoglycaemia and loss of glycaemic control associated with exercise. This loss of glycaemic control is associated with traditional moderate intensity continous aerobic exercise advocated in the guidelines for exercise in people with type 1 diabetes. Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is needed before firm conclusions can be drawn.
Therefore, the aim of this study is to determine the effects of HIT on glycaemic control in people with type 1 diabetes compared to no exercise and traditional moderate intensity continous exercise.
24 people with type 1 diabetes will be recruited to complete a randomised counterbalanced cross over study comparing 3x 2-week interventions periods. During these intervention periods participant will maintain their habitual lifestyle but complete either no exercise (control), traditional moderate intensity continous exercise or high intensity interval training. Throughout the intervention periods participants glycaemic control will be monitored using a flash glucose monitor.
연구 개요
상세 설명
Recruitment 24 people with type 1 diabetes (T1D) will be recruited through local advertising, e.g. within the Liverpool Type 1 Diabetes (LIVT1D) Group.
Protocol The study will use a randomised counterbalanced crossover design, whereby participants will complete 3x 2-week intervention periods; control (no exercise), moderate intensity continous training (MICT) and high intensity interval training (HIT).
Intervention period Participants will complete 3x 2-week intervention periods identical in all respects except for the type of exercise completed.
The day before each intervention period participants will attend the lab at Liverpool John Moores University to have an Abbot Freestyle Libre® flash glucose monitor inserted. To access the data participants will be provide with a "Reader" in "masked" mode, ensuring the participant cannot see the data produced. The Reader will also be used to record time of exercise, insulin doses and blood glucose. Finally, participants will be provided with an activity monitor (Actigraph®) for the duration of the intervention. Participants will also be familiarised to the type of exercise being performed.
In Addition, before the first intervention period participants will also be asked to download MyFitnessPal® to record their daily food intake. An anonymous login email address and password will be given to the participant for access to this App and associated website. A 1ml finger prick blood sample will also be taken on this first visit.
Participants will then complete the 2-week intervention period. During this period participants will be asked to maintain their habitual lifestyle, but only complete the exercise prescribed by the research team (HIT or MICT), or no exercise during the control intervention. Participants will be asked to exercise on day 1, 3, 6, 8, 10 and 13 of the intervention period. Exercise will be completed at any time, but must not be performed following an overnight fast. Participants will be asked to record their blood glucose immediately before and after exercise and 2h post exercise using a finger stick blood sample and automated glucose reader. If participants need to take additional carbohydrates to adjust blood glucose following exercise the investigators will also ask for this to be recorded (what was consumed and time after exercise) using a note in the MyFitnessPal app. Participants will record all insulin doses, time of exercise and food intake for the duration of the intervention period.
Training MICT: Participants will be asked to complete 30 minutes of continuous exercise. Participants will be able to choose any form of exercise (e.g. running or cycling) as long as it is continous in nature. During exercise participants will be asked to maintain a heart rate between 60-70% of their predicted maximum (220-age).
HIT: Participants will be provided with a training guide containing information on the exercises. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest. During the intervals participants will be advised to reach a heart rate of approx. 80% of their predicted maximum heart rate (220-age). The 1 minute interval will be split between 2 consecutive 30 second exercises. The research team have a library of 18 exercises, with 9 suggested exercise pairs. Participants will be advised to complete 6 intervals during each session.
Participants will complete training in a place of their choosing. If requested participants will be able to train in the labs at LJMU.
Participants will be given a polar H7/10 Bluetooth heart rate monitor. Participants will be advised to wear this monitor during all training sessions. The monitor will provide a measure of training intensity and compliance with the suggested heart rate and training programme.
Participants will be asked to download the App PolarBeat to their smartphone. This App will be used to monitor heart rate during the training sessions. In addition, participants will be given a login email address and password for PolarFlow (www.polar.flow.com), a cloud storage site run by Polar for the storage and analysis of heart rate data. All heart rate data measured during training sessions will be uploaded to Polar Flow. This will allow the research team to investigate training intensity achieved during all sessions.
Safety Subjects will be asked to check their blood glucose level to ensure it is safe to exercise. The investigators will use the guidelines that are currently used in a national study of exercise for patients with type 1 diabetes (EXTOD - see attached leaflet). Blood glucose will be checked immediately following exercise and corrected with fast acting carbohydrates if low. The investigators will also advise the subjects to check their glucose level before bed, and if necessary in the early hours of the morning (through setting an alarm clock) if this is required.
Flash Glucose Monitoring Analysis 9 key metrics of glycaemic control will be assessed, reported in 3 time blocks (sleep 00:00-06:00, wake 06:00- 00:00 and 24h 00:00- 00:00): 1) mean glucose, 2) % of time in level 2 hypoglycaemia (<3.0mmol/L), 3) % of time in level 1 hypoglycaemia (3.0-3.9mmol/L), 4) % of time in target range (3.9-10.0mmol/L), 5) % of time in level 1 hyperglycaemia (10.0-13.9mmol/L), 6) % of time in level 2 hyperglycaemia (>13.9mmol/L), 7) glycaemic variability, reported as CV and SD, 8) episodes of hypoglycaemia and hyperglycaemia and 9) area under the curve of episodes of hypoglycaemia and hyperglycaemia.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Liverpool, 영국, L33AF
- Matthew Cocks
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- T1D diagnosis more than 6 months ago
- Using a basal bolus insulin regime or insulin pump therapy
- BMI ≤ 32 kg.m-2
Exclusion Criteria:
- Pregnancy (or planning pregnancy)
- Disability preventing participation in an exercise regime
- Angina
- Autonomic neuropathy
- Medication that affects heart rate (this will affect estimation of fitness)
- Major surgery planned within 6 weeks of study
- Uncontrolled blood pressure
- Significant history of hyperglycaemia
- History of severe hypoglycaemia requiring third party assistance within the last 3 months
- Severe non-proliferative and unstable proliferative retinopathy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 제어
참가자는 습관적인 생활 방식을 유지하되 2주 동안 운동을 하지 않습니다.
|
|
|
활성 비교기: 중간 강도의 지속적인 훈련
참가자는 2주의 개입 기간 동안 중간 강도의 지속적인 훈련을 완료합니다.
|
참가자는 2주의 개입 기간 동안 중간 강도의 지속적인 훈련 6개 세션을 완료하게 됩니다.
참가자는 30분간의 지속적인 운동을 완료해야 합니다.
|
|
실험적: 고강도 인터벌 트레이닝
참가자는 2주간의 개입 기간 동안 고강도 인터벌 트레이닝을 완료합니다.
|
참가자는 2주간의 개입 기간 동안 6개의 고강도 인터벌 트레이닝 세션을 완료하게 됩니다.
이 프로그램은 1분간의 휴식과 함께 1분간의 간단한 제자리 동작을 반복하는 것입니다.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Severe hypoglycaemia (using continuous glucose monitoring)
기간: Over a 2 week intervention period
|
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
|
Over a 2 week intervention period
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean glucose (using continuous glucose monitoring)
기간: Over a 2 week intervention period
|
mean glucose level over 2 week recording period
|
Over a 2 week intervention period
|
|
% of time in level 2 hypoglycaemia (<3.0mmol/L) (using continuous glucose monitoring)
기간: Over a 2 week intervention period
|
% of time in level 2 hypoglycaemia (<3.0mmol/L) over 2 week recording period
|
Over a 2 week intervention period
|
|
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) (using continuous glucose monitoring)
기간: Over a 2 week intervention period
|
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) over 2 week recording period
|
Over a 2 week intervention period
|
|
% of time in target range (3.9-10.0mmol/L) (using continuous glucose monitoring)
기간: Over a 2 week intervention period
|
% of time in target range (3.9-10.0mmol/L)
over 2 week recording period
|
Over a 2 week intervention period
|
|
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) (using continuous glucose monitoring)
기간: Over a 2 week intervention period
|
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L)
over 2 week recording period
|
Over a 2 week intervention period
|
|
% of time in level 2 hyperglycaemia (>13.9mmol/L) (using continuous glucose monitoring)
기간: Over a 2 week intervention period
|
% of time in level 2 hyperglycaemia (>13.9mmol/L) over 2 week recording period
|
Over a 2 week intervention period
|
|
glycaemic variability (using continuous glucose monitoring)
기간: 2 weeks
|
Standard deviation in glucose concentrations obtained over a 2 week period using a continuous glucose monitoring device.
|
2 weeks
|
|
area under the curve of episodes of hypoglycaemia and hyperglycaemia
기간: Over a 2 week intervention period
|
area under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period
|
Over a 2 week intervention period
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .