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INSUlin Regimens and VASCular Functions (INSUVASC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01022658
First received: November 30, 2009
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
 Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Vago-sympathetic activity, arterial stiffness, endothelial function [ Time Frame: 4-5 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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®.

  Eligibility

Ages Eligible for Study:   30 Years to 72 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022658

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

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01022658     History of Changes
Other Study ID Numbers: P090303
Study First Received: November 30, 2009
Last Updated: February 20, 2013
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 22, 2013