ow calorie diet in obese type 2 diabetes patients treated with insuli

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN21335883
• Lead Sponsor: Imperial College London (UK)

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32049634/ results (added 03/06/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-23
• Study Completion: 2017-05-01
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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 < 10 years or greater than 10 years with a fasting c-peptide of >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 < 10 years

Original inclusion criteria:
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 < 4 years

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 11/09/2014:<br>1. Insulin use<br>2. Diabetes control<br>3. Beta-cell function<br>4. Cardiovascular risk factors (including obstructive sleep apnea)<br>5. Body composition<br>6. Effects on appetite and hunger<br>7. Other diabetes medications<br>8. Quality of life<br><br>Previous secondary outcome measures:<br>1. Changes in body composition<br>2. Diabetes control, insulin use, and other diabetes medication<br>3. Cardiovascular risk factors<br>4. Quality of life