Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Current interventions as of 11/09/2014:
Patients will be randomly allocated to receive either the low calorie diet or routine care for 6 months. This study will use between 800 calories as a benchmark
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/07/2015: 1. Have BMI >30 kg/m² 2. Men or women 3. Age 18-70 years 4. Are willing and able to give informed consent for participation in the study 5. Have been on insulin treatment 600 Previous inclusion criteria from 11/09/2014 to 23/07/2015: 1. Have BMI >30 kg/m² 2. Men or women 3. Age 18-70 years 4. Are willing and able to give informed consent for participation in the study 5. Have been on insulin treatment 30 kg/m² 2. Men or women 3. Age 18-70 years 4. Are willing and able to give informed consent for participation in the study 5. Have been on insulin treatment < 4 years
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/07/2015: 1. Have type 1 diabetes 2. Any significant diabetes microvascular complication 3. Are unable to provide written informed consent 4. Have experienced a cardiovascular disease (CVD) event in the previous 6 months 5. Are at stage 4 chronic kidney disease or greater (eGFR <30 mL/min/1.73 m²) 6. Have a mental incapacity, unwillingness and/or inability to understand, and be able to complete the mental health questionnaires in the provided language 7. Currently pregnant, lactating, or planning pregnancy within the study period 8. Have binge eating behaviour (will be assessed by Dutch Eating Behaviour Questionnaire) 9. Patient has condition precipitating fluid overload such as heart failure (New York Heart Association grade III-IV) and liver cirrhosis 10. Are using medication clinically deemed to affect metabolic rate and weight (e.g. beta blockers, corticosteroids, diuretics, etc) 11. Have significant psychiatric disorder (e.g. schizophrenia, anxiety, panic disorder, ADHD/ADD, post-traumatic stress disorder, obsessive-compulsive disorder) 12. Uncontrolled depression 13. Have participated in a weight management drug trial in the previous 3 months 14. Difficult to control International Normalising Ratio (INR) within the therapeutic range 15. Have uncontrolled epilepsy 16. Are known or suspected of substance use 17. Are lactose intolerant 18. Severe musculoskeletal conditions preventing walking 19. Gout 20. Have active gallstone disease or known asymptomatic gallstones 21. Clinically assessed hypoglycaemia unawareness 22. On ECG evidence of left bundle branch block Previous exclusion criteria from 11/09/2014 to 23/07/2015: 1. Have type 1 diabetes 2. Any significant diabetes microvascular complication 3. Are unable to provide written informed consent 4. Have experienced a cardiovascular disease (CVD) event in the previous 6 months 5. Are at stage 4 chronic kidney disease or greater (eGFR <30 mL/min/1.73 m²) 6. Have a mental incapacity, unwillingness and/or inability to understand, and be able to complete the mental health questionnaires in the provided language 7. Currently pregnant, lactating, or planning pregnancy within the study period 8. Have binge eating behaviour (will be assessed by Dutch Eating Behaviour Questionnaire) 9. Patient has condition precipitating fluid overload such as heart failure (New York Heart Association grade III-IV) and liver cirrhosis 10. Are using medication clinically deemed to affect metabolic rate and weight (e.g. beta blockers, corticosteroids, diuretics, etc) 11. Have significant psychiatric disorder (e.g. schizophrenia, anxiety, panic disorder, ADHD/ADD, post-traumatic stress disorder, obsessive-compulsive disorder) 12. Uncontrolled depression 13. Have participated in a weight management drug trial in the previous 3 months 14. Are on anticoagulant medication - excluding aspirin or clopidogrel 15. Have uncontrolled epilepsy 16. Are known or suspected of substance use 17. Are lactose intolerant 18. Severe musculoskeletal conditions preventing walking 19. Gout 20. Have active gallstone disease or known asymptomatic gallstones 21. Clinically assessed hypoglycaemia unawareness 22. On ECG evidence of left bundle branch block Original exclusion criteria: 1. Have type 1 diabetes 2. Have any significant diabetes microvascular complication 3. Are unable to provide written informed consent 4. Have experienced a cardiovascular disease (CVD) event in the previous 6 months 5. Are
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/09/2014: 1. Insulin use 2. Diabetes control 3. Beta-cell function 4. Cardiovascular risk factors (including obstructive sleep apnea) 5. Body composition 6. Effects on appetite and hunger 7. Other diabetes medications 8. Quality of life Previous secondary outcome measures: 1. Changes in body composition 2. Diabetes control, insulin use, and other diabetes medication 3. Cardiovascular risk factors 4. Quality of life | — |
Countries
England, United Kingdom
Outcome results
None listed