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Clinical Trials/ISRCTN76920690
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.

Registry
who.int
Start Date
April 5, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
eiden University Medical Center (Netherlands)

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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