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NCT Number: NCT02278926

Lypo-hypertrofia Characterization in Diabetes

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

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nigurada Hospital

Milan, 20162, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound

Other

Ultrasound measurements

Tapping and body inspection to define the area of insulin injection

Other

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

Primary outcomes

  1. Glucose control

    Time frame: month 3

    Glucose control by insulin therapy, measured by HbA1c values

Secondary outcomes

  1. Glucose control

    Time frame: month 12

    Glucose control by insulin therapy, measured by HbA1c values

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

Ultrasound Characterization of Lipo-hypertrophy in Type 1 Diabetes Mellitus

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 30, 2014
Registry last updated
Nov 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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