Overfeeding Induced Fat-tissue Stimulation

NCT ID: NCT06193668

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2030-12-31

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.

Conditions

Lipid-induced Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

High-fat overnutrition

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

Group Type: ACTIVE_COMPARATOR

High-fat overnutrition

Intervention Type: BEHAVIORAL

Overnutrition: 40% higher lipid consumption per day than required

Normocaloric macronutrient-balanced nutrition

Normocaloric, macronutrient-balanced nutrition per day over three weeks

Group Type: ACTIVE_COMPARATOR

Normocaloric macronutrient-balanced nutrition

Intervention Type: BEHAVIORAL

Normocaloric, macronutrient-balanced nutrition:

Calories requirement for weight maintenance [(kcal/d) 55% carbohydrates, 15% proteins, 30% fat]

Interventions

High-fat overnutrition

Overnutrition: 40% higher lipid consumption per day than required

Intervention Type: BEHAVIORAL

Normocaloric macronutrient-balanced nutrition

Normocaloric, macronutrient-balanced nutrition:

Calories requirement for weight maintenance [(kcal/d) 55% carbohydrates, 15% proteins, 30% fat]

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

German Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Roden, Prof., MD

Role: STUDY_DIRECTOR

German Diabetes Center

Locations

Georgia Xourafa

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Theresia Sarabhai, MD

Role: CONTACT

theresia.sarabhai@ddz.de

0173-9473478 ext. DDZ

Sabine Kahl, MD

Role: CONTACT

sabine.kahl@ddz.de

0221-3382- ext. 698

Facility Contacts

Georgia Xourafa, MD

Role: primary

georgia.xourafa@ddz.de

+492113382426

Theresia Sarabhai, MD

Role: backup

theresia.Sarabhai@ddz.de

0211-3382-0

Other Identifiers

OVID-FASTI

Identifier Type: -

Identifier Source: org_study_id