INSUlin Regimens and VASCular Functions

Study Overview
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Brief Summary
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Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now requiring insulin, to compare the effects of improving glycemic control on these parameters with 3 different insulin regimens which will act especially at fasting or in post-prandial periods or both. Non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.

Detailed Description
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Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The effect of controlling fasting or post-prandial blood glucose or both on these parameters has not been studied in type 2 diabetic patients. The aim of this pilot study is to compare the effects of improving fasting or post-prandial blood glucose glycemic control or both with 3 different insulin regimens for 4 to 5 weeks, on vago-sympathetic activity, arterial stiffness and endothelial function. Patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, and the department of Endocrinology and Metabolism of AVICENNE hospital, BOBIGNY, AP-HP, France. After an half day of cardiovascular explorations, 42 patients will be randomized in 3 groups determining their treatment for the following 4-5 weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or with both of them. Investigations will be performed in the morning 1) at the time of randomisation and 2) 4-5 weeks after the beginning of insulin therapy. We will evaluate at fasting and each hour after a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial function and nervous autonomic system with non-invasive devices: Sphygmocor®, Finapres®, laser-doppler et Endopat2000®. Body composition will be evaluated with impedance maestri and BodPod®.

Official Title
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Effects of Different Insulin Regimens on Artery Compliance, Endothelium Function and Autonomic Cardiac Function in Patients With Poorly Controlled Type 2 Diabetes: a Pilot Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent patient Adults from 30 to 72 years old type 2 diabetic patients for at least 1 year able to self measure capillary blood glucose body mass index 20-37 kg/m², HbA1c 7.1-12% under Metformin and SULFUNYREAS therapy for at least 2 months anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months Exclusion criteria: pregnancy other antidiabetic medication in the previous 2 months, anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months, insulin allergy, uncontrolled preproliferative or proliferative diabetic retinopathy uncontrolled hypertension renal failure(creatinin clearance <40 ml/min) hepatocellular deficiency (prothrombin time <70%) anemia peripheral occlusive arterial disease cardiac arrhythmia

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: detemir<br>Insulin detemir at dinner or bedtime | Drug: Insulin<br>* For diabetes treatment: metformin continued with insulin (according to arms)<br>* Other names: NOVORAPID;|
| Active Comparator: aspart<br>Insulin aspart before each meal | Drug: Insulin<br>* For diabetes treatment: metformin continued with insulin (according to arms)<br>* Other names: NOVORAPID;|
| Active Comparator: detemir and aspart<br> | Drug: Insulin<br>* For diabetes treatment: metformin continued with insulin (according to arms)<br>* Other names: NOVORAPID;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vago-sympathetic activity, arterial stiffness, endothelial function |  | 4-5 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Therapy, Vago-sympathetic activity, arterial stiffness, endothelial function