- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07565935
Effects of HIIT Following PTR Programme (HIITpostLCD)
Can High-Intensity Interval Training (HIIT) Reduce the Risk of Diabetes Relapse Following Discharge From the NHS Path to Remission Programme? - a Pilot Study
Caloric restriction programmes are highly effective and safe interventions for inducing rapid weight loss and improvements in glycaemic control. The landmark DiRECT study showed that 68% of people completing a caloric restriction intervention achieved remission of type 2 diabetes (T2D) by one year. Consequently, the NHS Path to Remission (PTR) programme was developed to stimulate diabetes remission in individuals that meet certain criteria. Unfortunately, long-term follow-up of the DiRECT study suggests that in the majority of participants that achieved remission, diabetes relapses within 5 years. This necessitates a focus on identifying methods to improve long-term maintenance of diabetes remission.
High-intensity interval training (HIIT) involves several brief bursts of intense exercise, interspersed with recovery breaks, and is becoming increasingly popular. HIIT can cause improvements in cardiovascular fitness, reduce blood pressure, and lower body fat content in only a fraction of the time of traditional exercise methods. Specific to T2D, HIIT has been shown to improve pancreatic beta cell function, which is critically important for maintenance of long-term diabetes remission.
This pilot study is being conducted to determine whether participating in a home-based HIIT training programme may help maintain beta cell function in individuals that have achieved diabetes remission following the NHS PTR programme. The study will take place at the Royal Derby Hospital.
The intention is to recruit 20 participants from Derbyshire or Nottinghamshire that have achieved diabetes remission in the NHS PTR programme. Participants will be recruited following discharge from the programme and allocated to either perform a HIIT training programme (intervention group), or continue with usual care (control group) for 16 weeks.
Before starting, participants will attend the research department to have initial measurements taken including bioimpedance, fasting bloods, an intravenous glucose tolerance test, muscle ultrasound, electromyography and cardiopulmonary exercise testing. Following this, those in the intervention group will be asked to perform a home-based HIIT training programme 3 times per week and record details of each session in a booklet. The control group will be asked to continue with their habitual levels of physical activity. Participants will be contacted regularly to ensure their safety and compliance.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Oluwaseun Anyiam
- 전화번호: +441332724605
- 이메일: oluwaseun.anyiam1@nottingham.ac.uk
연구 장소
-
-
-
Derby, 영국, DE22 3DT
- University of Nottingham, Royal Derby Hospital Centre
-
연락하다:
- Iskandar Idris
- 전화번호: +441332724605
- 이메일: iskandar.idris@nottingham.ac.uk
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults between the age of 18-70 years
- Ability to provide informed consent
- Completed the NHS Path to Remission programme and achieved diabetes remission (HbA1c <48mmol/mol (6.5%), and off diabetes medications for at least three months)
Exclusion Criteria:
- BMI > 40kg/m2
- Current participation in a formal exercise regime
- Current pregnancy or breastfeeding
- Uncontrolled hypertension (blood pressure >160/100mmHg)
History of cardiovascular disease:
- Symptomatic angina
- Heart failure (class III/IV)
- Significant arrhythmias
- Right to left cardiac shunt
- Recent acute coronary syndrome
- Severe aortic valvular disease
- Active cardiac infection
Background of the following respiratory diseases:
- Pulmonary hypertension
- Significant COPD
- Uncontrolled asthma
- History of malignancy undergoing current treatment or palliation
- Presence of significant musculoskeletal, neurological or cerebrovascular disease
- Any other medical condition deemed by the investigators to preclude inclusion into the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: HIIT group
This group will perform 16 weeks of high-intensity interval training.
This will involve performing a 15-minute routine, three times a week.
The exercise programme includes star jumps, standing squats, on-the-spot sprints, then repeating standing squats and star jumps again (this pyramid design has been chosen as it can be used to provide participants with a target of repetitions to achieve in the 4th and 5th interval).
|
High-intensity interval training
|
|
간섭 없음: Control group
This is the control group and will be asked to perform their usual habitual levels of activity for the 16 weeks of the study.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pancreatic beta cell function
기간: Assessed at baseline and then follow-up (16 weeks)
|
Assessment of beta-cell function using insulin first phase response from an intravenous glucose tolerance test
|
Assessed at baseline and then follow-up (16 weeks)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Insulin sensitivity
기간: Assessed at baseline and then follow-up (16 weeks)
|
Measured during the intravenous glucose tolerance test (IVGTT) and calculated from fasting glucose and insulin using the homeostatic model of assessment for insulin resistance
|
Assessed at baseline and then follow-up (16 weeks)
|
|
Overall glycaemic control
기간: Assessed at baseline and then follow-up (16 weeks)
|
From measurement of glycated haemoglobin (HbA1c)
|
Assessed at baseline and then follow-up (16 weeks)
|
|
Body weight
기간: Assessed at baseline and then follow-up (16 weeks)
|
Measurement of participant weight
|
Assessed at baseline and then follow-up (16 weeks)
|
|
Body composition
기간: Assessed at baseline and then follow-up (16 weeks)
|
Measurement of fat mass and fat-free mass using bioimpedance analysis
|
Assessed at baseline and then follow-up (16 weeks)
|
|
Skeletal muscle function
기간: Assessed at baseline and then follow-up (16 weeks)
|
Assessed using muscle strength (1 repetition maximum) testing and electromyography
|
Assessed at baseline and then follow-up (16 weeks)
|
|
Skeletal muscle structure
기간: Assessed at baseline and then follow-up (16 weeks)
|
Using muscle ultrasonography to assess muscle thickness, cross sectional area and fibre pennation angle
|
Assessed at baseline and then follow-up (16 weeks)
|
|
Cardiorespiratory fitness
기간: Assessed at baseline and then follow-up (16 weeks)
|
Determined from be the highest rate of oxygen consumption obtained (VO2max) during a cardiopulmonary exercise test
|
Assessed at baseline and then follow-up (16 weeks)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Iskandar Idris, University of Nottingham
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 24057
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
제2형 당뇨병에 대한 임상 시험
-
Postgraduate Institute of Medical Education and...완전한
-
RevBioNational Institute on Aging (NIA)아직 모집하지 않음AO/OTA Type 2R3C 원위 요골 골절
-
Chong Kun Dang Pharmaceutical완전한
-
Salzburger LandesklinikenMedizinische Einrichtungen der Universität Düsseldorf; Universitätsklinkum Münster - Medizinische... 그리고 다른 협력자들모병
-
Sohag Universitysohag university hospital모병
-
University Hospital Hradec Kralove완전한
-
Firat University아직 모집하지 않음다발성 경화증 | 운동 | 신경필라멘트 경쇄터키 (Türkiye)
Exercise에 대한 임상 시험
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for... 그리고 다른 협력자들완전한
-
Cukurova University완전한
-
The Hong Kong Polytechnic University완전한
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)완전한