INSUlin Regimens and VASCular Functions

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Insulin

• Registration Number: NCT01022658
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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®.

Study Timeline

• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Study Start: 2010-01
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
detemir	Insulin	Insulin detemir at dinner or bedtime
aspart	Insulin	Insulin aspart before each meal
detemir and aspart	Insulin	-

Primary Outcome Measures

Name	Time	Method
Vago-sympathetic activity, arterial stiffness, endothelial function	4-5 Weeks

Trial Locations

Locations (1)

Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition; 🇫🇷 Bondy, France