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

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NL-OMON24652
• Lead Sponsor: Initiator Prof. Dr. H.P. Sauerwein. Dept of Endocrinology & Metabolism, Academic Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

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

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%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Hepatic glucose production;<br>2. Lipolysis;<br>3. Proteolysis

Secondary Outcome Measures

Name	Time	Method
1. Plasma Glucose;<br>2. Free fatty acids levels.