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Clinical Trials in Germany / NCT06193668
Recruiting Not applicable

Overfeeding Induced Fat-tissue Stimulation

NCT06193668 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-01-31
Last updated
2024-03-01

Condition(s) studied

Lipid-induced Insulin Resistance

Investigational drug(s) / intervention(s)

High-fat overnutritionNormocaloric macronutrient-balanced nutrition

High-fat overnutrition: Overnutrition: 40% higher lipid consumption per day than required

Normocaloric macronutrient-balanced nutrition: Normocaloric, macronutrient-balanced nutrition: Calories requirement for weight maintenance \[(kcal/d) 55% carbohydrates, 15% proteins, 30% fat\]

Study 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

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Georgia Xourafa Düsseldorf North Rhine-Westphalia Recruiting

More German Diabetes Center trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06193668 on ClinicalTrials.gov ↗ ← All trials in Germany