Trial | NCT01022658  Report issue

Title

INSUlin Regimens and VASCular Functions
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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    42
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.
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®.
Study Started
Jan 31
2010
Primary Completion
Jul 31
2011
Study Completion
Jul 31
2011
Last Update
Feb 21
2013
Estimate

Drug Insulin

For diabetes treatment: metformin continued with insulin (according to arms)

  • Other names: LEVEMIR, NOVORAPID

detemir Active Comparator

Insulin detemir at dinner or bedtime

aspart Active Comparator

Insulin aspart before each meal

detemir and aspart Active Comparator

Criteria 

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
No Results Posted