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| Name | Class |
|---|---|
| Association of British Clinical Diabetologists | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIIT group | Experimental | 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). |
|
| Control group | No Intervention | This is the control group and will be asked to perform their usual habitual levels of activity for the 16 weeks of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | High-intensity interval training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic beta cell function | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | 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 |
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Inclusion Criteria:
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:
Background of the following respiratory diseases:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oluwaseun Anyiam | Contact | +441332724605 | oluwaseun.anyiam1@nottingham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Iskandar Idris | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham, Royal Derby Hospital Centre | Derby | DE22 3DT | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 26, 2024 | Mar 24, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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From measurement of glycated haemoglobin (HbA1c) |
| Assessed at baseline and then follow-up (16 weeks) |
| Body weight | Measurement of participant weight | Assessed at baseline and then follow-up (16 weeks) |
| Body composition | Measurement of fat mass and fat-free mass using bioimpedance analysis | Assessed at baseline and then follow-up (16 weeks) |
| Skeletal muscle function | Assessed using muscle strength (1 repetition maximum) testing and electromyography | Assessed at baseline and then follow-up (16 weeks) |
| Skeletal muscle structure | 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 | 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) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |