Diabetes mellitus Type 2
Conditions
Interventions
Group 1: Each participant will be examined four times during the course of clinical metabolic adjustment with semaglutide: before the start of treatment (baseline), approximately 24 hours after the fi
Sponsors
Universität Greifswald
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age: 18–60 years old Gender: Male and female BMI: Between 25 kg/m² and 40 kg/m² Type 2 diabetes mellitus (diagnosed no more than 10 years ago, HbA1c < 8.5%) Indication for treatment with semaglutide (Ozempic®) Use of a suitable method of contraception Written consent form available
Exclusion criteria
Exclusion criteria: Known diabetic complications Anamnestic symptoms consistent with gastroparesis (postprandial nausea, bloating and vomiting, early satiety, loss of appetite, postprandial upper abdominal pain) and weight loss. GLP-1 analog therapy within the last 3 months Side effects of GLP-1 analog therapy that require discontinuation of therapy. Disorders/diseases affecting the swallowing process (e.g., severe dysphagia with regard to food and/or solid oral dosage forms) Claustrophobia Known or suspected stenosis, fistulas, or mechanical obstructions within the gastrointestinal tract Surgical procedures on the gastrointestinal tract within the last 12 months Inflammatory bowel disease (Crohn's disease, ulcerative colitis, or diverticulitis) Implanted or portable electromechanical medical devices such as pacemakers, defibrillators, or infusion pumps Large dark tattoos Known allergies or intolerances to the ingredients in standard meals Alcohol or drug addiction Eating disorders such as anorexia or bulimia Positive pregnancy test or pregnancy or desire to have children Individuals who are known to be unwilling or unable to follow instructions reliably Individuals who are unable to understand written and verbal instructions and explanations regarding the risks of the study Less than 14 days after an acute illness Systemic use of other medications that affect the function of the gastrointestinal tract Simultaneous participation in interventional research projects; the interval between previous participation in other studies should not be less than 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recording and quantitative description of gastric motility in patients with diabetes mellitus undergoing medically indicated metabolic adjustment with semaglutide (Ozempic®) at four defined time points using MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Verification of the applicability and reproducibility of real-time MRI for dynamic quantification of gastric motility in a clinically heterogeneous patient population. | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Universität Greifswald
Outcome results
None listed