Overfeeding Induced Fat-tissue Stimulation (OVID_FASTI)

German Diabetes Center

Status: Enrolling

Conditions: Lipid-induced Insulin Resistance

Treatments: Behavioral: High-fat overnutrition; Behavioral: Normocaloric macronutrient-balanced nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT06193668

OVID-FASTI

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

High-fat overnutrition

Active Comparator group

Description:

Lipid overnutrition: 40% higher lipid consumption per day than required over three weeks.

Treatment:

Behavioral: High-fat overnutrition

Normocaloric macronutrient-balanced nutrition

Active Comparator group

Description:

Normocaloric, macronutrient-balanced nutrition per day over three weeks

Treatment:

Behavioral: Normocaloric macronutrient-balanced nutrition