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

Not Applicable

Completed

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

• Registration Number: ISRCTN76920690
• Lead Sponsor: eiden University Medical Center (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-05
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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)
11. Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
12. Pregnancy
13. Disease interfering with the use of a thiazolidinediones (TZD) (heart failure, oedema, liver function abnormalities) or participating in regular exercise

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Insulin sensitivity (as measured by hyperinsulinaemic euglycemic clamp)<br>2. Insulin signalling (measured in muscle biopsies)<br>3. Mitochondrial copy number (measured in muscle biopsies)<br>4. Low grade inflammation (measured in fasting blood samples)<br>5. Quality of Life (as measured by four different QoL questionnaires)<br>6. Ectopic fat depositions (as measured by magnetic resonance proton spectroscopy)

Secondary Outcome Measures

Name	Time	Method
ong-term effects