Primary objective;Change in section and extent of treated LH after treatment with endermotherapy® and without treatment. Change in resistance and pain during injection at the right and left LH and changes in appearance aspects of LH right and left.…
ID
Source
Brief title
Condition
- Other condition
- Epidermal and dermal conditions
Synonym
Health condition
Insuline geinduceerde lipohypertrofie bij DM1 en DM2
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* To determine a change in diameter and surface of treated LH after treatment
with endermotherapy® .
Secondary outcome
* 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
Background summary
During treatments with endermotherapy® , which is used for various skin
therapeutic indications, by chance a decrease in the presence of LH in DM
patients is noticed and an improvement in injection capabilities.
Hypothesis
Twenty patients with bilateral insulin induced LH, single sided LH on the body
will be treated with endermotherapy®. During this study insulin is not injected
into both LH. The consistency of the treated LH is significantly improved after
10 endermotherapy® treatments.
Study objective
Primary objective;
Change in section and extent of treated LH after treatment with endermotherapy®
and without treatment. Change in resistance and pain during injection at the
right and left LH and changes in appearance aspects of LH right and left.
Secondary objectives;
Change in pain and resistance during injection at the LH and changes in
appearance aspects of LH.
Locations of LH, years of attendance DM1 and DM2 at start study, years of LH at
start study, LH presence in various sex.
Study design
Randomised single blinded pilot study.
Intervention
During 10 weeks, 20 patients will be treated single-sided in LH, 2 times a week
during 10 minutes with endermotherapy®.
Study burden and risks
The population of patients is of age, able to regulate their own blood sugar
independent and do not inject in to examined LH during the study. When injected
in to examined LH there is an increased risk of hypoglycaemia because insulin
can be better absorbed and distributed.
At the risk of hypoglycaemia there should be an independently intake of
carbohydrates. The DM patient can compare this accelerated absorption of
insulin with performing a sport / physical activity. In everyday life this is a
standard anticipation for the DM1 and DM2 patient.
The study may only take place in patients with DM1 and DM2 which are mentally
competent, older than 18 and up to 70 years and in whom there is bilateral
insulin-induced LH. The treatments and measurements which are performed are
non-invasive and without risk. Because the patient is instructed, during the
nine weeks of the study, not to inject the examined LH, there is a low risk of
hypoglycaemia. The participating patients should independently regulate their
blood sugars.
At the end of 10 treatments, we expect that the treated LH will have changed.
Patient-related measurements
Measurement No. Week
LHVP patient questionnaire 5 1, 3, 5, 9, 10
Photography 3 1, 5, 9
Surface area measurements, 4 1, 3, 5, 9
Ultrasonic section measurements 4 1, 3, 5, 9
Harpenden section measurements 4 1, 3, 5, 9
Weight measurements 4 1, 3, 5, 9
Zambezilaan 189
Purmerend 1448ME
NL
Zambezilaan 189
Purmerend 1448ME
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52638.094.15 |