Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD

Obesity Clinical Trial

Official title:

Oxidative Stress and L-CBMN Cytome Assay Parameters Levels in Severely Obese With BMI ≥ 35kg/m2 After 3 Weeks 567 kcal Hospital Controlled VLCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055154
• Other study ID #: OSMN35aVLCD-26
• Status: Completed
• Phase: N/A
• Start date: June 14, 2019
• Est. completion date: November 3, 2020

Study information

• Verified date: September 2021
• Source: Special Hospital for Extended Treatment of Duga Resa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obesity leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and inflammation and can generate systematic oxidative stress through multiple biochemical mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, insulin resistance, inflammation and OS. The aim of this study is to determine the effect of a three-week VLCD on anthropometric, biochemical and genomic parameters in individuals with BMI ≥ 35kg/m2.

Description:

Obesity is a complex chronic multifactorial disease associated with concomitant or increased risk for chronic inflammation, insulin resistance, dyslipidemia, oxidative stress, type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress (OS) can cause permanent DNA damage which could be detected with lymphocytes cytokinesis-block micronucleus (L-CBMN) cytome assay. Weight loss and improvement of dietary habits in people with obesity can affect genome stability and have beneficial effects on insulin sensitivity, inflammation and OS. Effects of very low calorie diet (VLCD) on DNA damage are scarce. The aim of this study is to determine the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in patients with BMI ≥ 35kg/m2 on permanent DNA damage, lipid profile, insulin resistance, inflammation and anthropometric parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• body mass index = 35 kg/m2

Exclusion Criteria:

• pregnancy
• actual tumor diseases
• recent diagnostic or treatment exposures to ionizing radiation in the period of one year
• individuals not willing to stay 3 weeks under supervision under full 24 h surveillance from the medical stuff

Related Conditions & MeSH terms

• DNA Damage
• Obesity
• Weight Loss

Intervention

Device:
• Very low calorie diet
In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks

Locations

Country	Name	City	State
Croatia	Special Hospital for Extended Treatment of Duga Resa	Duga Resa

Sponsors (3)

Lead Sponsor	Collaborator
Special Hospital for Extended Treatment of Duga Resa	Institute for Medical Research and Occupational Health, University of Zagreb

Country where clinical trial is conducted

Croatia, 

References & Publications (17)

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes in body mass index	Body mass index is calculated by dividing body mass (kg) with square of body height (m)	Baseline, after 3 weeks of VLCD
Primary	The changes in the body fat mass	Body fat mass (kg) assessed with bioelectrical impedance method	Baseline, after 3 weeks of VLCD
Primary	The changes in the skeletal muscle mass	Skeletal muscle mass (kg) assessed with bioelectrical impedance method	Baseline, after 3 weeks of VLCD
Primary	The changes in the percent body fat	Percent body fat (%) assessed with bioelectrical impedance method	Baseline, after 3 weeks of VLCD
Primary	The changes in fasting glucose concentration	Concentration of glucose (mmol/L)	Baseline, after 3 weeks of VLCD
Primary	The changes in urea concentration	Concentration of urea (mmol/L)	Baseline, after 3 weeks of VLCD
Primary	The changes in lipid profile	Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)	Baseline, after 3 weeks of VLCD
Primary	The changes in insulin concentration	Concentration of insulin (mIU/L)	Baseline, after 3 weeks of VLCD
Primary	The changes in homeostatic model assessment (HOMA) index	HOMA index is calculated according to the following formula: glucose (mmol/L) x insulin (mIU/L)/22.5	Baseline, after 3 weeks of VLCD
Primary	The changes in inflammation parameters	Concentration of C-reactive protein (mg/L) and total white blood cell count	Baseline, after 3 weeks of VLCD
Secondary	The changes in oxidative stress	Concentration of glutathione (RFU) and reactive oxygen species (RFU)	Baseline, after 3 weeks of VLCD
Secondary	The changes in DNA damage	Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes	Baseline, after 3 weeks of VLCD