NCT05490862

Brief Summary

The study of the pro-inflammatory activation of circulating monocytes/macrophages in obesity is the main problem of this project. The investigation of pro-inflammatory activation of monocytes and determination of the level of mitochondrial genome mutations, assessment of traditional CVD risk factors and the degree of cardiovascular risk and atherosclerosis indicators and their association will be investigated in dynamics on 12-weeks weight loss.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

August 1, 2022

Last Update Submit

June 5, 2023

Conditions

ObesityCardiovascular Diseases

Keywords

obesityCardiovascular risk factorsatherosclerosisInflammationMonocytesCytokines

Outcome Measures

Primary Outcomes (2)

  • Changes of pro-inflammatory macrophages activation

    The measurement of basal and lipopolysaccharide-induced tumor necrosis factor-α and interleukin-1β levels in the culture of cluster differentiation 14+ cells obtained from participants blood samples

    Twice: Baseline, treatment week 12

  • Mitochondrial genome mutations

    The assessment of mtDNA mutation heteroplasmy m.652delG, m.1555A\>G, m.3336T\>C, m.3256C\>T, m.5178C\>A, m.12315G\>A, m.13513G\>A, m.14459G\>A , m.14846G\>A и m.15059G\>A by real-time polymerase chain reaction

    One time measurement (baseline)

Secondary Outcomes (6)

  • Changes of body mass

    Twice: Baseline, treatment week 12

  • Changes of body fat mass

    Twice: Baseline, treatment week 12

  • Changes of skeletal muscle mass

    Twice: Baseline, treatment week 12

  • Changes of Serum Cholesterol levels

    Twice: Baseline, treatment week 12

  • Framingham Risk Score

    Twice: Baseline, treatment week 12

  • +1 more secondary outcomes

Study Arms (3)

Obese Weight Loss group

EXPERIMENTAL

Low-calorie diet and regular physical trainings will be administered to obese participants (BMI \>30kg/m\^2).

Behavioral: Lifestyle Modification

Obese Control group

ACTIVE COMPARATOR

Traditional weight loss recommendations will be provided to obese participants (BMI \>30kg/m\^2)

Behavioral: Traditional Recommendations

Lean Control group

NO INTERVENTION

The data of these subjects will be used as a control

Interventions

Lifestyle ModificationBEHAVIORAL

An individualized low-calorie diet is characterized by sugars and starchy food intake restriction, 500 kcal daily energy deficit for 12 weeks (3 months). Regular physical activity is represented by individualized 30 minutes trainings on an anti-gravity treadmill 3 workouts per week for 12 weeks with individual targets of stepping activity, which will be evaluated according to personal fitness monitoring data

Obese Weight Loss group
Traditional RecommendationsBEHAVIORAL

The list of traditional diet and physical activity recommendations for patients with obesity

Obese Control group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥30 kg/m2
  • BMI \<25 kg/m2

You may not qualify if:

  • Diabetes Mellitus
  • Cancer
  • Uncontrolled Hypertension
  • Decompensated liver or kidney disease
  • III-IV classes of Chronic Heart Failure
  • Other chronic diseases (except CVDs) on permanent treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Pathology and Diet

Moscow, 115446, Russia

RECRUITING

MeSH Terms

Conditions

ObesityCardiovascular DiseasesAtherosclerosisInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic Processes

Study Officials

  • Yurgita R Varaeva, MD, MRes

    Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yurgita R Varaeva, MD, MRes

CONTACT

+79253841894varaeva@ion.ru

Natalia Shaposhnikova, MD

CONTACT

+7985 274 96 82buchkova@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Match pairs Parallel group Double-control design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, Research Fellow

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 8, 2022

Study Start

January 11, 2022

Primary Completion

September 1, 2023

Study Completion

December 14, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Per reasonable request to principal investigator

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2 years after study completion
Access Criteria
Per reasonable request
More information

Locations

RU(1)