NCT06193668 Overfeeding Induced Fat-tissue Stimulation
| NCT ID | NCT06193668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | German Diabetes Center |
| Condition | Lipid-induced Insulin Resistance |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2024-01-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Type 2 diabetes is the most common metabolic disease worldwide, characterized by hyperglycemia, decreased whole body insulin sensitivity, and white adipose tissue (WAT) dysfunction. A key factor in its development is chronic overnutrition, usually with a high-fat diet (HFD), leading to disturbances of glucose and lipid metabolism. However, the mechanism of short-term HFD-induced tissue-specific insulin resistance remains poorly understood. This project aims to further unravel the underlying mechanisms of short-term HFD overnutrition-mediated WAT insulin resistance. The model described here corresponds to a randomized, single- blinded parallel-grouped trial, consisting of two interventions: a macronutrient-balanced diet and or a hypercaloric diet over three weeks in order to investigate differences in interorgan fatty acid and glucose metabolism between the studied groups. Based on recent studies, the hypothesis is that 21-day hypercaloric HFD induces WAT insulin resistance via a diacylglycerol, novel protein kinase C-insulin receptor signaling model in both fasting and insulin-stimulated states.
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 40 years * BMI \< 29 kg/m2 * Sport inactive (\<1x /week) * Capacity to consent Exclusion Criteria: * Diabetes mellitus disease * Acute coronary heart syndrome (myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack in the last 3 months before study participation) * Acute infectious disease * Taking blood glucose-lowering drugs * Diseases or drugs affecting the immune system and allergies to drugs used in the study * Drugs with potential metabolic effects * Chronic liver disease (hepatitis, gallbladder disease, elevated liver enzymes (ALT \> 300 U/L)) * Chronic inflammatory bowel diseases * Rheumatic diseases * Hyper- or hypothyroidism of the thyroid gland * Renal insufficiency, administration of iodine-containing contrast media in the last 2 days * Chronic lung diseases * cancerous diseases * Addictive diseases, psychiatric diseases * Pregnancy, breastfeeding * Shift workers * Anemia (Hb \<12 g/dl) * Disorders of hemostasis * Regular use of antithrombotic drugs * Alcohol consumption, smoking * Conditions that do not permit an MRI examination
Contact & Investigator
Michael Roden, Prof., MD
STUDY DIRECTOR
German Diabetes Center
Frequently Asked Questions
Who can join the NCT06193668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Lipid-induced Insulin Resistance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06193668 currently recruiting?
Yes, NCT06193668 is actively recruiting participants. Contact the research team at theresia.sarabhai@ddz.de for enrollment information.
Where is the NCT06193668 trial being conducted?
This trial is being conducted at Düsseldorf, Germany.
Who is sponsoring the NCT06193668 clinical trial?
NCT06193668 is sponsored by German Diabetes Center. The principal investigator is Michael Roden, Prof., MD at German Diabetes Center. The trial plans to enroll 32 participants.