Actively Recruiting
Overfeeding Induced Fat-tissue Stimulation
Led by German Diabetes Center · Updated on 2024-03-01
32
Participants Needed
1
Research Sites
360 weeks
Total Duration
On this page
Sponsors
G
German Diabetes Center
Lead Sponsor
Y
Yale University
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Overfeeding Induced Fat-tissue Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 40 years
- Body mass index (BMI) less than 29 kg/m2
- Inactive in sports (less than once per week)
- Ability to give consent
You will not qualify if you...
- Diagnosed diabetes mellitus
- Acute coronary heart syndrome or stroke within the last 3 months
- Acute infectious disease
- Taking blood glucose-lowering medications
- Diseases or medications affecting the immune system or allergies to study drugs
- Use of drugs with potential metabolic effects
- Chronic liver diseases or elevated liver enzymes (ALT > 300 U/L)
- Chronic inflammatory bowel diseases
- Rheumatic diseases
- Hyperthyroidism or hypothyroidism
- Renal insufficiency or recent iodine contrast administration
- Chronic lung diseases
- Cancerous diseases
- Addictive or psychiatric diseases
- Pregnancy or breastfeeding
- Shift work
- Anemia (hemoglobin < 12 g/dl)
- Disorders of blood clotting
- Regular use of antithrombotic drugs
- Alcohol consumption or smoking
- Conditions preventing MRI examination
AI-Screening
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Trial Site Locations
Total: 1 location
1
Georgia Xourafa
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
Research Team
T
Theresia Sarabhai, MD
CONTACT
S
Sabine Kahl, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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