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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76920690

Enrollment

Registered

2011-04-05

Start date

2005-05-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2 Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

One patients group followed a 16-week very low calorie diet. The other patient group followed a 16-week very low calorie diet combined with an exercise program, which consisted of a one hour in-hosp

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Long-term effects	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026