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Normalization of Fasting Glucose and the Incidence of Restenosis After Peripheral Angioplasty

NCT01150617 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2012-09-13

No results posted yet for this study

Summary

Primary objective of the study is to test whether an intensified insulin therapy incorporating the target of normal fasting glucose (\<5.5 mmol/L) and glycated hemoglobin \<6.5% is able to halve the incidence of angiographic restenosis at 6 months (expected rate 45%, to be reduced at 15%) after peripheral angioplasty compared with standard care to achieve a glycated hemoglobin \<7.0% in patients with type 2 diabetes and limb ischemia.

Secondary objectives include the identification of markers associated with, and predictive of, restenosis and the investigation of the underlying pathophysiological background, with specific focus on the role of nitric oxide (NO), mechanisms of endothelial activation/apoptosis, inflammation and matrix remodeling risk profiles, candidate gene polymorphisms and endothelial progenitor cells evaluation.

Methodology: This is a randomized, open-label, clinical trial comparing two regimens of insulin therapy having as an outcome measure the incidence of angiographic restenosis at 6 months after peripheral angioplasty. Seventy consecutive patients with type 2 diabetes and peripheral arterial disease undergoing peripheral angiography and subsequent angioplastic procedure will be studied. Patients will be treated by intensive insulin therapy, based on three pre-prandial administrations of regular insulin or short acting insulin analogues combined with the long-acting insulin analogue glargine or standard care based on once-daily insulin and oral antidiabetics agents. Patients randomized to the intensive insulin therapy arm will be educated and followed up with daily measurements of fasting glucose and weekly phone contacts with the target of fasting glucose \<5.5 mmol/L (99 mg/dl) to obtain glycated hemoglobin \<6.5%. The control arm will be followed to achieve a target of glycated hemoglobin \<7.0%. Life style recommendations, including diet and physical activity program, will be the same for the two arms. All patients will undergo three visits with physical examination and blood sampling, at baseline and at 2, 4 and 6 months after angioplasty. Moreover, patients on normal fasting glucose arm will be monitored by phone on weekly basis in order to test their adherence to therapeutic target.

Conditions

Interventions

DRUG

Insulin glargine plus insulin analogues

* Intensified insulin therapy: three administrations of regular insulin or short acting insulin analogues before meals combined with long-acting insulin analogue glargine in the evening. The treatment goal will be a fasting blood glucose level of 5.5 mmol/L (99 mg/dl) and a HbA1c\<6.5% at the end of the follow-up. * Standard care: treatment will be once-daily long-acting insulin and oral antidiabetic agents to achieve HbA1c levels of \< 7.0% at the end of the follow-up.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • PierMarco Piatti, MD · San Raffaele Scientific Institute, Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-11-30
Completion
2011-05-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01150617 on ClinicalTrials.gov