ISRCTN21335883
Completed
N/A
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
Imperial College London (UK)0 sites90 target enrollmentOctober 23, 2012
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 2 diabetes
- Sponsor
- Imperial College London (UK)
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32049634/ results (added 03/06/2020)
Investigators
Eligibility 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 \< 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
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
Outcomes
Primary Outcomes
Not specified
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