Overfeeding Induced Fat-tissue Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-fat overnutrition, Normocaloric macronutrient-balanced nutrition.
- Who it may be relevant to
- Registry conditions: Lipid-induced Insulin Resistance. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Short-term High-fat Overnutrition Induces Insulin Resistance in White Adipose Tissue
Overview
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.
Interventions
- Behavioral High-fat overnutrition
Overnutrition: 40% higher lipid consumption per day than required - Behavioral Normocaloric macronutrient-balanced nutrition
Normocaloric, macronutrient-balanced nutrition: Calories requirement for weight maintenance \[(kcal/d) 55% carbohydrates, 15% proteins, 30% fat\]
Primary outcome measures
- Whole-body insulin sensitivity and WAT insulin sensitivity [Time frame: 3 weeks intervention period each]
Secondary outcome measures (1)
- WAT insulin signaling pathways [Time frame: 3 weeks intervention time]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- Georgia Xourafa — Düsseldorf
Identifiers
NCT: NCT06193668 · OVID-FASTI