Type 2 Diabetes
Conditions
Keywords
Insulin Therapy, Vago-sympathetic activity, arterial stiffness, endothelial function
Brief summary
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
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®.
Interventions
DRUGInsulin
For diabetes treatment: metformin continued with insulin (according to arms)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 72 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vago-sympathetic activity, arterial stiffness, endothelial function | 4-5 Weeks |
Countries
France
Outcome results
None listed