Obesity Clinical Trial
— DELISAOfficial title:
The Role of De Novo Lipogenesis in Regulation of Insulin Sensitivity in Adipose Tissue in Obese
Verified date | February 2023 |
Source | Charles University, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | March 11, 2022 |
Est. primary completion date | March 11, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 45 Years |
Eligibility | Inclusion Criteria: - sedentary premenopausal women - lean (n=20-25, age 25-40 years, BMI 20-25 kg/m2) - obese (n=20-25, age 25-40 years, BMI 30-40 kg/m) Exclusion Criteria: - diagnosed cancer - diabetes (T1DM and T2DM) - liver and renal diseases - major cardiovascular event - bariatric surgery - allergy to lidocaine - positive serology for hepatitis (B and C) and HIV - smoking above 10 cigarettes/day, alcohol consumption above 66g/day - sleep apnea - poor venous status - weight-change more than 3kg in last 3 months - untreated hyper- or hypo-thyroidism - long term use of medication and/or steroids - shift workers and individuals with abnormal sleep/wake pattern |
Country | Name | City | State |
---|---|---|---|
Czechia | Charles University | Prague | |
Czechia | Faculty Hospital Kralovske Vinohrady | Prague |
Lead Sponsor | Collaborator |
---|---|
Charles University, Czech Republic | Faculty Hospital Kralovske Vinohrady, Institut National de la Santé Et de la Recherche Médicale, France |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory outcome into adipose tissue lipolysis | Change in glycerol, FFA concentration in AT explants | through study completion, an average of 1 year | |
Other | Exploratory outcome into liver lipogenesis | Change in amount of liver fat and VLDL-TG composition | through study completion, an average of 1 year | |
Primary | Insulin sensitivity | Change in insulin sensitivity index (?iAUC insulin/?iAUC glucose from OGTT) | through study completion, an average of 1 year | |
Primary | De Novo Lipogenesis in adipose tissue | Change in mRNA expression of lipogenic genes and by targeted and non-targeted lipid analysis (?CT) | through study completion, an average of 1 year | |
Secondary | gene expression profiling of adipose tissue | Change in long non-coding RNA analysis by microarrays (?CT) | through study completion, an average of 1 year |
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