Lypo-hypertrofia Characterization in Diabetes

Ultrasound Characterization of Lipo-hypertrophy in Type 1 Diabetes Mellitus

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Ultrasound; Other: Tapping and body inspection to define the area of insulin injection

Detailed Description

An observational study has been carried out, checked with parallel arms in which type 1 diabetes patients are recruited with clinical evidence of lypo-hypertrophy in insulin injected areas. Patients attend to the Diabetes Unit of Niguarda Ca' Granda Hospital. 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 the investigators manage to define the lypo-hypertrophic area by tapping and body inspection. In the study group the investigators can define and mark out the area/areas with lipo-hypertrophy by ultrasound scan test. All the tested patients both the control group and the study group, are discouraged from use insulin in areas where lypo-hypertrophy is present. Patients are reassessed after 3 months with a clinical assessment of glucose control by HbA1c. After 12 months subcutaneous tissue scan is repeated in 10 patients within the experimental group and a new assessment of HbA1c is performed. Ultrasound assessment. The scan used is Esaote My Lab70 linear probe multi-frequency [6-18 Mhz)

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20162
    • Nigurada Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 1 diabetes patients with visible lypo-hypertrphy that attend consecutively in our outpatient clinic

Description

Inclusion Criteria:

• type 1 diabetes
• age between 18 and 75 years old
• lack of extended cutaneous diseases
• BMI <30

Exclusion Criteria:

• BMI> 30
• active allergies
• cancer
• liver failure
• kidney failure

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients ultrasound lypo-hypertrophy identification; Type 1 diabetes patients with visible lypo-hypertrphy attended in outpatient clinic	Other: Ultrasound; Ultrasound measurements
Control group; Type 1 diabetes patients with visible lypo-hypertrphy attended in outpatient clinic	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose control	Glucose control by insulin therapy, measured by HbA1c values	month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose control	Glucose control by insulin therapy, measured by HbA1c values	month 12

Collaborators and Investigators

• Sponsor: Niguarda Hospital
• Investigators: Study Chair: Eleonora Bruschi, MD, Niguarda Hospital; Study Chair: Oscar Epis, MD, Niguarda Hospital; Principal Investigator: Federico Bertuzzi, MD, Niguarda Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimate): October 30, 2014

Study Record Updates

• Last Update Posted (Estimate): November 2, 2014
• Last Update Submitted That Met QC Criteria: October 31, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Ultrasound; Lypo-hypertrophy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 442-092014