MedTrace Logo

Lypo-hypertrofia Characterization in Diabetes

NCT02278926 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2014-11-03

No results posted yet for this study

Summary

Aim/hypothesis: Subcutaneous insulin absorption is one of the factors which strongly influence blood sugar control in patients with diabetes mellitus on insulin therapy. In response, a regular absorption is influenced by lipo-hypertrophy in subcutaneous tissue on injection sites. So far lipo-hypertrophy diagnosis has only been clinical since there are no imaging studies that have characterized precisely morphometry of lipo-hypertrophic tissue. Methods: In two groups of 20 type 1 diabetes patients on insulin therapy, lipo-hypertrophy is characterized and defined by clinical tapping or by ultrasound with multi frequency linear probe (6-18 Mhz). Patients are therefore advised to avoid insulin injections on those areas so defined. Patients are reevaluated 3 and 12 months later

Conditions

  • Type 1 Diabetes Mellitus

Interventions

OTHER

Ultrasound

Ultrasound measurements

OTHER

Tapping and body inspection to define the area of insulin injection

Obese patients with a thickening fat subcutaneous tissue that could have interfered with the interpreting and analyzing of the data are left out of this first study. In the control group we manage to define the lypo-hypertrophic area by tapping and body inspection

Sponsors & Collaborators

  • Niguarda Hospital

    lead OTHER

Principal Investigators

  • Eleonora Bruschi, MD · Niguarda Hospital

  • Oscar Epis, MD · Niguarda Hospital

  • Federico Bertuzzi, MD · Niguarda Hospital

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT02278926 on ClinicalTrials.gov