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INSUlin Regimens and VASCular Functions (INSUVASC)

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ClinicalTrials.gov Identifier: NCT01022658
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Insulin Not Applicable

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®.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: detemir
Insulin detemir at dinner or bedtime
Drug: Insulin
For diabetes treatment: metformin continued with insulin (according to arms)
Other Names:
  • LEVEMIR
  • NOVORAPID

Active Comparator: aspart
Insulin aspart before each meal
Drug: Insulin
For diabetes treatment: metformin continued with insulin (according to arms)
Other Names:
  • LEVEMIR
  • NOVORAPID

Active Comparator: detemir and aspart Drug: Insulin
For diabetes treatment: metformin continued with insulin (according to arms)
Other Names:
  • LEVEMIR
  • NOVORAPID




Primary Outcome Measures :
  1. Vago-sympathetic activity, arterial stiffness, endothelial function [ Time Frame: 4-5 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022658


Locations
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France
Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition
Bondy, France, 93140
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Paul Valensi, Pr CHU Jean VERDIER
Study Chair: Emmanuel Cosson, MD, PhD CHU-Jean Verdier

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01022658     History of Changes
Other Study ID Numbers: P090303
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Insulin Therapy
Vago-sympathetic activity
arterial stiffness
endothelial function

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs