ISRCTN76920690
Completed
未知
Short and long term effect of a Very Low Calorie Diet (VLCD) with or without exercise in obese insulin-dependent type 2 diabetes mellitus patients: A randomised controlled trial
eiden University Medical Center (Netherlands)0 sites28 target enrollmentApril 5, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diabetes mellitus type 2
- Sponsor
- eiden University Medical Center (Netherlands)
- Enrollment
- 28
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Type 2 diabetes mellitus patients
- •2\. Body mass index (BMI) \> 30 kg/m2 (but weight has to be greater than 90 kg to sustain a 16 week VLCD)
- •3\. Age \> 30 years
- •4\. Use of at least 30 units of insulin/day with or without oral blood glucose lowering agents
- •5\. Fasting c\-peptide level \> 0\.8 ng/l and a two times rise on 1 mg glucagon (intravenous) IV
Exclusion Criteria
- •1\. No residual insulin secretory capacity as defined by no response to a glucagon stimulation test
- •2\. Weight above 130 kg and fasting plasma glucose \>15 mmol/l
- •3\. Any significant chronic disease
- •4\. Renal, hepatic or another endocrine disease
- •5\. Use of medication known to influence lipolysis and/or glucose metabolism
- •6\. Recent weight changes or attempts to lose weight ( \> 3 kg weight gain or loss, within the last 3 months)
- •7\. Difficulties to insert an intravenous catheter
- •8\. Smoking
- •9\. Severe claustrophobia (ventilated hood)
- •10\. Recent blood donation (within the last 3 months)
Outcomes
Primary Outcomes
Not specified
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