NCT04260542: DELISA

De Novo Lipogenesis and Insulin Sensitivity in Obese

Completed NA Last updated 15 February 2023

What this trial tests

NA trial testing Fasting/refeeding in Insulin Resistance in 66 participants. Completed in 11 March 2022.

Timeline

1 May 2019

Primary endpoint
11 March 2022

11 March 2022

Quick facts

Lead sponsor	Charles University, Czech Republic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	66
Start date	1 May 2019
Primary completion	11 March 2022
Estimated completion	11 March 2022
Sites	2 locations across Czechia

Drugs / interventions tested

• Fasting/refeeding
• Fasting/refeeding
• Ketogenic diet/ fasting

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →
• Obesity — all drugs for Obesity →

Sponsor

Charles University, Czech Republic

Who can join

Adults 25 to 45, female only, with Insulin Resistance or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Disturbances of de novo lipogenesis (DNL) are one of the features of dysfunction of adipose tissue (AT). Disturbances of DNL play a role in development of metabolic complications of obesity. The goal of this project is to investigate novel pathways of DNL regulation. DNL will be studied during nutritional interventions in healthy and obese subjects in exposure to 2-days high carbohydrate diet preceded by a) 2-days fasting b) several weeks´ ketogenic diet. This nutritional protocol creates conditions for the study of prominent changes in DNL: suppression of DNL during fasting or ketogenic diet followed by stimulation during high-carbohydrate diet. Systemic phenotypic features and molecular indices of DNL regulation in AT will be followed during the protocols. Specific attention will be paid to newly reported pathway- hormone sensitive lipase and transcription factor ChREBP. The results will contribute to development of pharmacological approaches in the treatment of metabolic complications of obesity, targeted selectively to AT, without side effects in other tissues.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Obesity alters adipose tissue response to fasting and refeeding in women: A study on lipolytic and endocrine dynamics and acute insulin resistance
   Rossmeislová L, Krauzová E, Koc M, Wilhelm M, et al · · 2024
2. Obesity alters adipose tissue response to fasting and refeeding in women: A study on lipolytic and endocrine dynamics and acute insulin resistance.
   Rossmeislová L, Krauzová E, Koc M, Wilhelm M, et al · · 2024 · PMID 39328508 · DOI 10.1016/j.heliyon.2024.e37875