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NCT Number: NCT06193668

Overfeeding Induced Fat-tissue Stimulation

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.

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Key information

Conditions

Lipid-induced Insulin Resistance

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-fat overnutrition

Behavioral

Overnutrition: 40% higher lipid consumption per day than required

Normocaloric macronutrient-balanced nutrition

Behavioral

Normocaloric, macronutrient-balanced nutrition:

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

Primary outcomes

  1. Whole-body insulin sensitivity and WAT insulin sensitivity

    Time frame: 3 weeks intervention period each

    Hyperinsulinemica-euglycemia clamp tests with deuterated glucose to measure fasting and insulin-stimulated whole-body insulin sensitivity and measurement of the index ADIPO-IR (fasting insulin x free fatty acid concentration) before and after dietary intervention period.

Secondary outcomes

  1. WAT insulin signaling pathways

    Time frame: 3 weeks intervention time

    Adipose tissue biopsies are planned to be taken during the fasting and insulin-stimulated state before and after the dietary intervention period. DAG and ceramide subcellular fractionation assay is planned to be performed. Expressionanalyses for activation /membrane translocation of novel and atypical protein kinase C isoforms will be done. Determination of the degree of phosphorylation of various components of the insulin pathway via Western blot are planned.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Kahl, MD

CONTACT

[email protected]

0221-3382- ext. 698

Theresia Sarabhai, MD

CONTACT

[email protected]

0173-9473478 ext. DDZ

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Collaborators

  • Yale University

Registry information

Official study title

Short-term High-fat Overnutrition Induces Insulin Resistance in White Adipose Tissue

Acronym: OVID_FASTI

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Jan 5, 2024
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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