Patients with diabetes mellitus may have an increased risk of reduced muscle mass and muscle strength.
In our research project, we want to find out whether diabetes mellitus is actually associated with a premature decline in muscle health in our patients.
Aim of the study
In this information document, we refer to our research project as a research project. If you take part in this research project, you are a participant.
In this research project, we want to investigate how diabetes mellitus affects muscle health. We are asking you because all persons who have been diagnosed with diabetes mellitus can participate.
Who can take part?
Patients with diabetes mellitus
Procedure
First visit:
During your regular appointment at our consultation, we will measure your hand grip strength. To do this, you must press a measuring device with each hand as hard as possible. To measure the strength of your legs, we measure the time you need to stand up and sit down five times. We then place a lightweight plastic watch on your wrist (motion meter), which you should not take off for a week. It is not necessary to operate the clock. You must return the watch to us. The watch is read out by the study doctor.
For your regular appointment you will need to allow an extra 30 minutes. We will take 3 more small tubes (max. 30ml) as part of the already planned routine blood collection. We examine the amount of certain RNA molecules and proteins from skeletal muscle in the blood samples in the laboratory. Participants who have agreed to undergo DNA testing will be screened for genetic changes (so-called polymorphisms and methylations) that could be important for muscle health. In an MRI (magnetic resonance imaging) scan, we measure the fat content and mass of your thigh muscles. The examination takes place without contrast medium and only takes 5-10 minutes. For participants without a muscle biopsy, participation in the project ends after the exercise meter has been returned.
Second visit:
Participants who have agreed to undergo a muscle biopsy will be invited for a separate appointment. For this, they must appear sober (without food, only water from midnight). The maximum time required for this visit is one hour. A needle biopsy of the muscle is a standard procedure and is performed in many laboratories worldwide. Before the biopsy, you will be asked about allergies to the local anesthetic lidocaine and the procedure described below will be explained to you again step by step. You will then have another opportunity to ask questions.
While lying down, a small area of skin on the outside of the thigh is cleared of hair, disinfected and a local anesthetic (2% lidocaine) is applied with a needle so that you do not feel any pain when the sample is taken. The anesthetic can be felt with a small sting or a slight burning sensation. The skin and subcutaneous tissue are then opened with a small incision and a special biopsy needle is inserted into the muscle and a muscle sample is taken. You will be informed beforehand to relax the muscle as much as possible and that the biopsy may cause unusual pressure or twinges in the muscle. After removing the needle, pressure and a cold pack are applied to the puncture site for 10-15 minutes. The puncture site is then treated with wound adhesive and bandaged. The bandage should be worn for another 4 days before you remove it yourself or it falls off on its own. You may shower, but not bathe for 4 days. After a muscle biopsy, most people report that they were able to return to light sport the very next day. The photo on the left shows that a biopsy scar is usually barely visible:
Compensation
If you participate in this research project, you will not receive any compensation. An exception applies to muscle biopsies. An expense allowance is paid for the performance of a muscle biopsy and the associated travel in a sober state.
Original study name
Skeletal Muscle Health in Diabetes and Aging (SKIING)
BASEC number
2022-00585
Sponsors
The research project is mainly financed by independent research funding.