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Overfeeding Induced Fat-tissue Stimulation

NCT06193668 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-03-01

No results posted yet for this 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.

Conditions

  • Lipid-induced Insulin Resistance

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 \[(kcal/d) 55% carbohydrates, 15% proteins, 30% fat\]

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • German Diabetes Center

    lead OTHER

Principal Investigators

  • Michael Roden, Prof., MD · German Diabetes Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-12-31
Completion
2030-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06193668 on ClinicalTrials.gov