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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Kaberi
Dasgupta
+1 (0)514 934 1934
kaberi.dasgupta@mcgill.ca
Dr
Matthew
McCarthy
+44 (0)116 258 4323
mm636@leicester.ac.uk
Prof
Tom
Yates
+44 (0)116 258 4312
ty20@leicester.ac.uk
Miss
Debbie
Chan
+1 (0)514 934 1934
debbie.chan@rimuhc.ca
Type 2 diabetes mellitus (T2DM)
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Type 2 diabetes is a condition that causes the level of sugar (glucose) in the blood to become too high. It is becoming more common and adults are getting it at younger ages. Many young adults (aged between 18-40 years) are now being diagnosed with the disease. This is worrying because heart, kidney and physical function problems related to diabetes can therefore happen at an early age. Past studies have shown that low-energy diets lead to over half of people reversing their type 2 diabetes. This means that blood sugar levels return to normal. This is called ‘reversing diabetes.’ A low-energy diet means eating a lot less than normal for a short period of time. Once people have lost enough weight, they can start to eat regular food again. Structured exercise, such as walking and simple weight training activities, can also improve blood sugar levels as well as heart function. The effects of combining the two approaches - a low-energy diet and structured exercise - have not been studied together in terms of reversing diabetes. The main goal of this study is to see whether combining structured exercise and a low-calorie diet can reverse diabetes. The study will also look at whether heart health is improved over 24 weeks.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36130753/ (added 22/09/2022)
You can take part if:
Current inclusion criteria as of 24/08/2022:
1. Age 18 to 45 years, inclusive
2. Type 2 diabetes: physician diagnosis more than 3 months and less than 6 years previously
3. Hemoglobin A1c 6.5% to 10%, inclusive if not taking glucose-lowering medication; 6.0% to 10% if taking glucose-lowering medication
4. Body mass index 30 kg/m² to 45 kg/m², inclusive if White or Indigenous¹, 27 kg/m² to 45 kg/m², inclusive if other background, including mixed
5. Weight stability: weight changes of less than 5 kg over the prior 6 months
6. Walking ability: able to walk without assists and to participate in structured exercise training requiring the lower limbs
7. Capacity: able to understand written and spoken English and/or French
8. Able to provide informed consent
9. Willing to be randomized and able to participate
10. Willing to attend supervised exercise sessions, if so randomized
11. Willing to adopt low energy diet, including abstinence from alcohol, if so randomized
12. Willing to self-monitor glucose and blood pressure at the required frequency, if randomized to the low energy diet plus supervised exercise arm
¹Term for the original peoples of North America and their descendants; includes First Nations, Inuit, and Métis peoples
²An exception is made for women who are on insulin therapy in case of pregnancy occurrence because of insulin’s established safety profile in pregnancy, rather than because of inability to control glycemia on oral agents alone. If these women are willing and able to use a reliable f
You may not be able to take part if:
Current exclusion criteria as of 24/08/2022:1. Other diabetes types:1.1. Type 1 diabetes1.2. Gestational diabetes1.3. Monogenic diabetes 2. Poorly controlled blood pressure: resting systolic blood pressure greater than 150 mmHg or resting diastolic blood pressure greater than 90 mmHg diastolic 3. Weight loss interventions: currently participating in a weight reduction program in addition to routine care 4. Previous bariatric surgery 5. Medications:5.1. Insulin therapy² 5.2. Use of licensed weight loss medications 5.3. Significant changes in glucose-lowering medications in the prior 3 months, as judged by study physicians 5.4. Steroids by mouth or injection 6. Allergies: self-reported allergies or intolerances to components of the meal replacement products (e.g., milk protein allergy)7. Dietary practices that prohibit the use of meal replacement products 8. Pregnancy, lactation or planning to become pregnant in the next 8 months 9. Eating disorder: self-reported or diagnosed 10. Substance abuse: alcohol, drugs 11. Estimated glomerular filtration rate: less than 60 ml.min-1 per 1.73m² 12. Retinopathy: receiving or requiring active treatment for retinopathy 13. Clinically manifest vascular disease: 13.1. Myocardial infarction 13.2. Stroke 13.3. Peripheral vascular disease 14. Other cardiac disease:14.1. Heart failure 14.2. Atrial fibrillation 14.3. Pacemaker 14.4. Implantable cardioverter defibrillator (ICD) 15. Other conditions that could impact weight and/or safety: active malignancy or other chronic disease 16. Run-in phase:16.1. Failure to complete at least 5 or requested 7 days of accelerometer wear 16.2. Failure to complete a food diary for three weekdays and one weekend day
Previous exclusion criteria:1. Individuals with type 1, gestational or monogenic diabetes mellitus2. On insulin therapy (An exception may be made for women who are on insulin therapy in case of pregnancy occurrence because of insulin’s established safety profile in pregnancy, rather than because of inability to control glycaemia on oral agents alone. If these women are willing and able to use a reliable form of contraception, they may be enrolled.)3. eGFR <60 ml.min-1 per 1.73m² 4. Currently participating in a weight reduction program in addition to routine care5. Previous bariatric surgery6. Currently on injected steroids 7. Currently on weight loss medications (not including glucose-lowering medication)8. Conditions that could impact weight (i.e., active malignancy/treatment in past year, pregnancy, lactation, planning to become pregnant in next 8 months)9. Individuals with a self-reported or diagnosed eating disorder10. Self-reported milk protein allergy or other allergy or dietary practice that prohibits the use of meal replacement products11. Previous myocardial infarction, stroke, amputation secondary to T2DM/peripheral vascular disease, or other evidence of clinically manifest vascular disease12. Previous clinically diagnosed atrial fibrillation13. Previous clinically diagnosed heart failure 14. Pacemaker or implantable cardioverter-defibrillator (ICD)15. Substance abuse. The requirement for alcohol abstinence during the initial 12 weeks will make it unlikely that individuals with alcohol dependence will enrol. Substance abuse will be queried. 16. Average resting blood pressure >150 mmHg systolic and/or >90 mmHg diastolic. In the case of borderline hypertension, individuals will be offered the opportunity to repeat the test at a later date. 17. Currently receiving or requiring active treatment for retinopathy.18. Current participation in another research study with investigational medical product
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Kaberi
Dasgupta
+1 (0)514 934 1934
kaberi.dasgupta@mcgill.ca
Prof
Tom
Yates
+44 (0)116 258 4312
ty20@leicester.ac.uk
Dr
Matthew
McCarthy
+44 (0)116 258 4323
mm636@leicester.ac.uk
Miss
Debbie
Chan
+1 (0)514 934 1934
debbie.chan@rimuhc.ca
The study is sponsored by University of Leicester; McGill University Health Centre and funded by Medical Research Council; Canadian Institutes of Health Research; John R McConnell Foundation.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 48343
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
