Lipohypertrophy and endermotherapy® Effect of endermotherapy® treatment in insulin induced lipohypertrophy in type 1 and 2 Diabetes Mellitus patients.

Lipohypertrophy and endermotherapy® Effect of endermotherapy® treatment in insulin induced lipohypertrophy in type 1 and 2 Diabetes Mellitus patients. - Insulin induced lipohypertrophy and endermotherapy®

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44781

Enrollment

Registered

2015-12-22

Start date

2016-03-29

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insuline geinduceerde lipohypertrofie bij DM1 en DM2 injection sites Insulin injections induced Lipohypertrophy

Interventions

During 10 weeks, 20 patients will be treated single-sided in LH, 2 times a week during 10 minutes with endermotherapy®.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Type 1 and type 2 Diabetes Mellitus patients F/M, bilateral insulin injections induced lipohypertrophy (LH), from 18 to 70 years, able to use different injection sites instead of the lipohypertrophic sites (in consultation with diabetes care nurse), insulin injections in lipohypertophy is not allowed during research, ability, able to regulate blood sugar independently. Willingness to leave body weight unchanged during research.

Exclusion criteria

Exclusion criteria: Absence of insulin -induced bilateral LH, incompetent, under 18, over 70 years, prednison use, pregnancy, breastfeeding, malignant tumors and abnormalities in abdominal organs. Heart failure, past 6 months myocardial infarction or stroke , renal dysfunction with the MDRD is below 50. Use of anticoagulants. No alternate injection sites, not able to regulate blood sugars.

Design outcomes

Primary

Measure	Time frame
* To determine a change in diameter and surface of treated LH after treatment with endermotherapy® .	—

Secondary

Measure	Time frame
* To determine a change in diameter of untreated LH after nine weeks not injecting * To determine a change in surface of untreated LH after nine weeks not injecting * To determine a change in appearance aspect of untreated LH by researcher * To determine a change in appearance aspect of treated LH by researcher * To determine a change in appearance aspect of untreated LH by patient * To determine a change in appearance aspect of treated LH by patient * To determine pain when injected into untreated LH before start study * To determine pain when injected into treated LH before start study * To determine pain when injected into untreated LH in 10th week of study * To determine pain when injected into treated LH in 10th week of study * To determine resistance when injected in treated LH before start study * To determine resistance when injected in untreated LH before start study * To determine resistance when injected in treated LH in 10th week of study * To determine resistance when injected untreated LH in 10th week of study * To determine if there is a difference between the treatment effect at various locations LH * To determine if there is a difference between the treatment effect in short term and long existing DM * To determine if there is a difference between the treatment effect in short term and long existing LH * To determine if there is a difference between the treatment effect on the different types of sex	—

Measure

Time frame

* To determine a change in diameter of untreated LH after nine weeks not injecting * To determine a change in surface of untreated LH after nine weeks not injecting * To determine a change in appearance aspect of untreated LH by researcher * To determine a change in appearance aspect of treated LH by researcher * To determine a change in appearance aspect of untreated LH by patient * To determine a change in appearance aspect of treated LH by patient * To determine pain when injected into untreated LH before start study * To determine pain when injected into treated LH before start study * To determine pain when injected into untreated LH in 10th week of study * To determine pain when injected into treated LH in 10th week of study * To determine resistance when injected in treated LH before start study * To determine resistance when injected in untreated LH before start study * To determine resistance when injected in treated LH in 10th week of study * To determine resistance when injected untreated LH in 10th week of study * To determine if there is a difference between the treatment effect at various locations LH * To determine if there is a difference between the treatment effect in short term and long existing DM * To determine if there is a difference between the treatment effect in short term and long existing LH * To determine if there is a difference between the treatment effect on the different types of sex

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)