Differences in glucose production, lipolysis and proteolysis during different basal insulins, in patients with type 2 diabetes.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24652

Enrollment

Registered

2007-03-27

Start date

2007-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Type 2 Diabetes Mellitus

Interventions

The patients are admitted to the metabolic unit of the Academic Medical Center at 4.30 pm, with the last meal and usual insulin dosage of short-acting insulin taken at 12.00 am. The long-acting insuli

Eligibility

Inclusion criteria

Inclusion criteria: 1. Caucasian male patients with DM II; 2. Basal bolus insulin therapy with NPH, detemir or glargine for at least 1 year; 3. Basal insulin dosage: 30 ± 10 U; 4. Fasting plasma glucose: 7,5-10,0 mmol/l; 5. HbA1C 7.5 - 9%; 6. Age 40-65; 7. BMI 26-30 kg/m2

Exclusion criteria

Exclusion criteria: 1. Major flaws in injection technique, as indicated by subcutaneous infiltration; 2. Creatinine > 100 µmol/L or diabetic nephropathy; 3. Abnormal liver enzymes (>2x upper limit of normal) and fasting triglycerides > 3 mmol/L; 4. Clinically manifest autonomic neuropathy; 5. Macrovascular complications of DM II, except for peripheral arterial disease; 6. Epilepsy; 7. Drugs interfering with insulin sensitivity and lipolysis, other than metformin; 8. Alcohol abuse (>5/day); 9. Fever/infection; 10. Dietary fat content >75%

Design outcomes

Primary

Measure	Time frame
1. Hepatic glucose production; 2. Lipolysis; 3. Proteolysis	—

Secondary

Measure	Time frame
1. Plasma Glucose; 2. Free fatty acids levels.	—

Contacts

Public ContactM.R. Soeters

Academic Medical Center (AMC) Department of Endocrinology & Metabolism, F5-162 P.O. Box 22660

m.r.soeters@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)