Investigating how insulin resistance affects weight loss with semaglutide in non-diabetic obese patients
Treatment Response to Incretin Mimetics in Non-diabetic Obese Patients With and Without Insulin Resistance (TRIM-IR)
This study is testing how insulin resistance affects weight loss in non-diabetic obese people taking semaglutide to see if it helps them lose weight better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | ETH Zurich Academic / other |
| Locations | 1 site (Aarau, Canton of Aargau) |
| Trial ID | NCT06856291 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the impact of insulin resistance on weight loss outcomes in non-diabetic obese individuals undergoing treatment with semaglutide, a medication known for its effectiveness in weight management. The study will assess participants over a 16-week period, focusing on changes in body composition, weight loss, and adipose tissue function. By examining molecular markers of adipose tissue dysfunction, the research seeks to understand why some individuals experience limited responses to semaglutide therapy. The findings could provide insights into optimizing treatment for those with varying degrees of insulin resistance.
Who should consider this trial
Good fit: Ideal candidates for this study are non-diabetic obese individuals aged 18 to 60 with a BMI between 30 and 40 kg/m2.
Not a fit: Patients who are pregnant or breastfeeding will not benefit from this study due to safety concerns regarding semaglutide use in these populations.
Why it matters
Potential benefit: If successful, this study could lead to more personalized weight loss interventions for non-diabetic obese patients, improving treatment outcomes.
How similar studies have performed: While there have been studies on semaglutide's effects in diabetic and non-diabetic populations, this specific investigation into insulin resistance's role in treatment response is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 60 years 2. BMI 30 - 40 kg/m2 a. Participants must meet the eligibility criteria for coverage under the KVG (Federal Health Insurance Act) and the Specialties List, which include a weight-related comorbidity (arterial hypertension, dyslipidemia) for participants with a BMI of 30- 35 kg/m2 3. Planned therapy with semaglutide as a weight loss intervention 4. No known presence of a diabetic state 5. Ability to understand and sign a Patient Information and Consent Form Exclusion Criteria: 1. Pregnancy or active breast feeding 1. Therapy with semaglutide is not approved for use during pregnancy or while breastfeeding, as its safety and efficacy in these conditions have not been established. 2. Pregnancy is an exclusion criterion for the planned investigations to avoid placing pregnant individuals under unnecessary physical or psychological stress that could pose risks to both the individual and the fetus. 2. Medication and/or pathologies that prevent the safe execution of the fat tissue biopsies (e.g. allergy towards local anesthetics, disorders of coagulation, treatment with anticoagulants) 3. Medical conditions that prevent examinations and testing (e.g. epilepsia, symptomatic cardiovascular disease) 4. History of or planned bariatric surgery 5. HbA1c ≥ 6.5% as measured by the central laboratory at screening 6. Fasting plasma-glucose \>7.0 mmol/l 7. History of type 1 or type 2 diabetes mellitus 8. Treatment with glucose-lowering agent(s) (e.g. Metformin) within 90 days before screening 9. Treatment with a GLP-1 (glucagon like peptide 1) receptor agonist within 180 days before screening 10. A self-reported change in body weight \>5% within 90 days before screening 11. Active malignancy (\<2a since remission) 12. Treatment with any medication for the indication of obesity within the past 90 days before screening 13. Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) \> 10 mIU/L or \< 0.4 mIU/L as measured by the central laboratory at screening
Where this trial is running
Aarau, Canton of Aargau
- Cantonal Hospital Aarau — Aarau, Canton of Aargau, Switzerland (Recruiting)
Study contacts
- Study coordinator: Katja M Leitner, Dr. med. univ.
- Email: katja.leitner@hest.ethz.ch
- Phone: +41628384184
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.