Diabetes 

Recruitment status:

Recruiting

Primary Sponsor:

Imperial College London (UK)

Recruitment countries:

United Kingdom

Health condition studied:

Type 2 diabetes
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

URL:

Link to the clinical trial website

About the trial

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 for the low calorie diet. For the first 12 weeks, the patients will be asked to consume a low calorie diet. After this, the patients in the intervention group will gradually have conventional food re-introduced for the next 12 weeks. Patients in the routine care group will be asked to consume a 600 calorie deficit diet throughout the intervention. After 6 months, all patients will be transferred to the same care and follow a 600 calorie deficit diet and will be followed up for 6 months. Throughout this time patients will received behaviour change to help with long-term maintenance.

Previous interventions:
Patients will be randomly assigned to receive the Cambridge Diet or routine care for 6 months. The Cambridge Diet group will follow a low calorie diet and routine care will follow a 600 calorie deficit diet. Patients in the intervention group will consume 800 calories for 3 months, thereafter they will follow the 1400 calorie diet for the remaining 3 months. Patients in the routine care will consume 600 calorie deficit diet throughout the intervention. After the intervention all patients will be transferred to routine care.

The previous sponsor for this trial (up to 11/09/2024) was:
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Key inclusion and exclusion criteria:

• Inclusion criteria: Current inclusion criteria as of 11/09/2014:
  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
  
  Previous 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 11/09/2014:
  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
  
  Previous 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 at stage 3b chronic kidney disease (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 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 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. Have severe arthritis preventing walking
  19. Have gout
  20. Have active gallstone disease or known asymptomatic gallstones

• Age minimum:
• Age maximum:
• Gender: Both

Primary outcomes:

Weight loss

Secondary outcomes:

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

Target sample size:

90

Study type:

Interventional

Study design:

Randomised controlled trial (Treatment)

Contacts:

• Name:
• Address:
• Phone:
• Email:
• Affiliation:

• Name: Gary Frost
• Address: Division of Diabetes, Endocrinology and Metabolism 6th Floor Commonwealth Building Faculty of Medicine Imperial College Hammersmith Campus DuCane Road
• Phone:
• Email: g.frost@imperial.ac.uk
• Affiliation:

Technical details

Scientific title:

A randomised controlled trial assessing the impact of a Low Calorie Diet on weight loss in obese patients with type 2 Diabetes Mellitus treated with insulin

Sources of monetary support:

Current sources of funding as of 11/09/2014:, Cambridge Weight Plan Ltd (UK), Previous sources of funding:, The Cambridge Manufacturing Company (UK), NIHR CLAHRC BBC

Secondary sponsors:

Main ID:

ISRCTN21335883

Secondary ID:

N/A

Register:

ISRCTN

Date of registration:

23/10/2024

Date of first enrollment:

01/09/2024

Last refreshed:

13 January 2025