ObesityNCT05490862
Inflammatory Status of Monocytes in Obesity
A study testing Lifestyle Modification and Traditional Recommendations in people with Obesity and Cardiovascular Diseases, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Obesity, Cardiovascular Diseases
- What is being tested?
- Lifestyle Modification and Traditional Recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 11 Jan 2022to 14 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Pathology and Diet
Moscow, 115446
Yurgita Varaeva, MD, MRes, +79253841894, varaeva@ion.ru
Natalia Shaposhnikova, MD, +79852749682, buchkova@mail.ru
About this study
Official title: Inflammatory Status of Monocytes in Obesity: Association With Atherosclerosis Indicators and the Effectiveness of Weight Loss
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.
Read the detailed description
Obesity is one of the main risk factors for cardiovascular disease (CVD), which occupy the first place in the overall structure of mortality in developed countries, and therefore it is a serious medical and social problem and an urgent research topic in modern science. Inflammation is one of the key factors in the development of cardiovascular complications of obesity, in particular atherogenesis. Currently, the mechanisms of inflammation in obesity are widely studied, in experimental studies, special attention is paid to the study of macrophages of adipose tissue, their inflammatory activation and their role in the development of obesity-associated pathological conditions. Circulating monocytes in dense tissue differentiate into macrophages and play an important role in the pathogenesis of chronic inflammation. Increased pro-inflammatory activation of macrophages in the focus of inflammation can cause chronic inflammation and contribute to the development of atherosclerotic lesions in the vascular wall. Mitochondrial dysfunction may play a special role in the proinflammatory activation of monocytes since it leads to the accumulation of oxygen radicals and activates the excessive secretion of inflammatory mediators. Mitochondrial genome mutations are one of the possible mechanisms leading to the development of mitochondrial dysfunction. Previously, atherosclerosis-associated mutations of the mitochondrial genome were identified, however, in obesity, the level of mitochondrial heteroplasmy has not been studied. Weight loss is associated with a decrease in cardiovascular risk; however, the mechanisms of the cardioprotective effects of weight loss are not fully understood. The anti-inflammatory effects of vigorous exercise in obesity are being actively studied. The study of the pro-inflammatory activation of circulating monocytes/macrophages in obesity is the main problem of this project. The following tasks will be solved within the framework of the project: 1. Investigation of pro-inflammatory activation of monocytes and determination of the level of mitochondrial genome mutations in obese individuals. 2. Comprehensive assessment of the association of monocyte activation, mitochondrial genome mutations and traditional CVD risk factors and the degree of cardiovascular risk and atherosclerosis indicators in obese individuals. 3. Study on the effect of weight loss after a 3-month course of body weight loss, consisting of a set of physical exercises in combination with a low-calorie diet on the inflammatory status of monocytes in obese individuals.
As a result of the project, data on the inflammatory status of monocytes in obesity will be obtained and published, the effect of pro-inflammatory activation of monocytes, mitochondrial genome mutations in combination with traditional CVD risk factors on indicators of atherosclerosis and cardiovascular risk in obese individuals will be investigated. Data on the effect of a weight loss intervention (a combination of exercise complex and low-calorie diet) on the inflammatory status of monocytes will be obtained and published. The study of cellular markers of inflammation and the identification of mitochondrial genome mutations in obese individuals will deepen the understanding of the mechanisms of chronic inflammation in obesity and obesity-associated cardiovascular complications. The study of the effect of weight loss on the inflammatory status of monocytes - key cells in the development of chronic inflammation - may become a promising direction for the development of approaches for personalized pathogenetic therapy of obesity and prevention of obesity-associated cardiovascular complications.
- Conditions
- Obesity, Cardiovascular Diseases
- Being tested
- Lifestyle Modification, Traditional Recommendations
- Keywords
- obesity, Cardiovascular risk factors, atherosclerosis, Inflammation, Monocytes, Cytokines
- Medical subject headings
- Obesity, Cardiovascular Diseases, Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ModificationBehavioural
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
Traditional RecommendationsBehavioural
The list of traditional diet and physical activity recommendations for patients with obesity
| Study group | Role | What they receive |
|---|---|---|
| Obese Weight Loss group | Experimental | Low-calorie diet and regular physical trainings will be administered to obese participants (BMI >30kg/m^2). Receives: Behavioral: Lifestyle Modification |
| Obese Control group | Active comparator | Traditional weight loss recommendations will be provided to obese participants (BMI >30kg/m^2) Receives: Behavioral: Traditional Recommendations |
| Lean Control group | No intervention | The data of these subjects will be used as a control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: One time measurement (baseline)
Secondary outcomes (6)
Changes of body mass
Includes repeated assessment of body mass (kg) and calculation of percentage of weight loss.
Measured: Twice: Baseline, treatment week 12
Changes of body fat mass
Includes repeated assessment of body fat mass (%) by bio-impedancemetry body composition analysis and calculation of fat mass loss.
Measured: Twice: Baseline, treatment week 12
Changes of skeletal muscle mass
Includes repeated assessment of skeletal muscle mass (%) by bio-impedancemetry body composition analysis and calculation of muscle mass changes (positivo or negative).
Measured: Twice: Baseline, treatment week 12
Changes of Serum Cholesterol levels
The measurement of serum total cholesterol and cholesterol sbgroups levels by standard laboratory procedures. The decrease of cholesterol levels is considereed as positeve effect.
Measured: Twice: Baseline, treatment week 12
Framingham Risk Score
The assessment of estimated 10-year cardiovascular risk (%) according to the Framingham Risk Score that varies from less than 10% (low risk) to more than 20% (high risk). The reduction od risk will be considered as positive effect of intervention.
Measured: Twice: Baseline, treatment week 12
Intima-media thickness
The assessment of intima-media thickness of common carotid artery evaluated by B-mode ultrasound imagining.
Measured: One time measurement (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start11 Jan 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion14 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Match pairs Parallel group Double-control design
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Collaborators
- Petrovsky National Research Centre of Surgery
- Responsible party
- Principal investigator, Yurgita R. Varaeva, MD, MRes, Federal State Budgetary Scientific Institution
- Investigators
- Yurgita R Varaeva, MD, MRes, Principal investigator, Federal State Budgetary Scientific Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490862
- Sponsor's protocol ID
- 22-25-00414
- Status last verified
- Jun 2023
- First submitted
- 1 Aug 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per reasonable request to principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Status of Monocytes in Obesity: Association With Atherosclerosis Indicators and the Effectiveness of Weight Loss
- ClinicalTrials.gov ID
- NCT05490862
- Acronym / sponsor ID
- 22-25-00414
- Conditions
- Obesity, Cardiovascular Diseases
- Keywords
- obesity, Cardiovascular risk factors, atherosclerosis, Inflammation, Monocytes, Cytokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Collaborators
- Petrovsky National Research Centre of Surgery
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 14 Dec 2023 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is one of the main risk factors for cardiovascular disease (CVD), which occupy the first place in the overall structure of mortality in developed countries, and therefore it is a serious medical and social problem and an urgent research topic in modern science. Inflammation is one of the key factors in the development of cardiovascular complications of obesity, in particular atherogenesis. Currently, the mechanisms of inflammation in obesity are widely studied, in experimental studies, special attention is paid to the study of macrophages of adipose tissue, their inflammatory activation and their role in the development of obesity-associated pathological conditions. Circulating monocytes in dense tissue differentiate into macrophages and play an important role in the pathogenesis of chronic inflammation. Increased pro-inflammatory activation of macrophages in the focus of inflammation can cause chronic inflammation and contribute to the development of atherosclerotic lesions in the vascular wall. Mitochondrial dysfunction may play a special role in the proinflammatory activation of monocytes since it leads to the accumulation of oxygen radicals and activates the excessive secretion of inflammatory mediators. Mitochondrial genome mutations are one of the possible mechanisms leading to the development of mitochondrial dysfunction. Previously, atherosclerosis-associated mutations of the mitochondrial genome were identified, however, in obesity, the level of mitochondrial heteroplasmy has not been studied. Weight loss is associated with a decrease in cardiovascular risk; however, the mechanisms of the cardioprotective effects of weight loss are not fully understood. The anti-inflammatory effects of vigorous exercise in obesity are being actively studied. The study of the pro-inflammatory activation of circulating monocytes/macrophages in obesity is the main problem of this project. The following tasks will be solved within the framework of the project: 1. Investigation of pro-inflammatory activation of monocytes and determination of the level of mitochondrial genome mutations in obese individuals. 2. Comprehensive assessment of the association of monocyte activation, mitochondrial genome mutations and traditional CVD risk factors and the degree of cardiovascular risk and atherosclerosis indicators in obese individuals. 3. Study on the effect of weight loss after a 3-month course of body weight loss, consisting of a set of physical exercises in combination with a low-calorie diet on the inflammatory status of monocytes in obese individuals.
As a result of the project, data on the inflammatory status of monocytes in obesity will be obtained and published, the effect of pro-inflammatory activation of monocytes, mitochondrial genome mutations in combination with traditional CVD risk factors on indicators of atherosclerosis and cardiovascular risk in obese individuals will be investigated. Data on the effect of a weight loss intervention (a combination of exercise complex and low-calorie diet) on the inflammatory status of monocytes will be obtained and published. The study of cellular markers of inflammation and the identification of mitochondrial genome mutations in obese individuals will deepen the understanding of the mechanisms of chronic inflammation in obesity and obesity-associated cardiovascular complications. The study of the effect of weight loss on the inflammatory status of monocytes - key cells in the development of chronic inflammation - may become a promising direction for the development of approaches for personalized pathogenetic therapy of obesity and prevention of obesity-associated cardiovascular complications.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Match pairs Parallel group Double-control design
| Arm | Type | Receives |
|---|---|---|
| Obese Weight Loss group | Experimental | Behavioral: Lifestyle ModificationLow-calorie diet and regular physical trainings will be administered to obese participants (BMI >30kg/m^2). |
| Obese Control group | Active comparator | Behavioral: Traditional RecommendationsTraditional weight loss recommendations will be provided to obese participants (BMI >30kg/m^2) |
| Lean Control group | No intervention | –The data of these subjects will be used as a control |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Diabetes Mellitus
- Cancer
- Uncontrolled Hypertension
- Decompensated liver or kidney disease
- III-IV classes of Chronic Heart Failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ModificationAn 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 | Behavioural | Obese Weight Loss group |
| Traditional RecommendationsThe list of traditional diet and physical activity recommendations for patients with obesity | Behavioural | Obese Control group |
Primary outcome
Changes of pro-inflammatory macrophages activation
Time frame: Twice: Baseline, treatment week 12
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
Mitochondrial genome mutations
Time frame: One time measurement (baseline)
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
6 secondary outcomes
Changes of body mass
Time frame: Twice: Baseline, treatment week 12
Changes of body fat mass
Time frame: Twice: Baseline, treatment week 12
Changes of skeletal muscle mass
Time frame: Twice: Baseline, treatment week 12
Changes of Serum Cholesterol levels
Time frame: Twice: Baseline, treatment week 12
Framingham Risk Score
Time frame: Twice: Baseline, treatment week 12
Intima-media thickness
Time frame: One time measurement (baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: Yes. Per reasonable request to principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yurgita R Varaeva, MD, MRes principal investigator
Federal State Budgetary Scientific Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification and Traditional Recommendations in people with Obesity and Cardiovascular Diseases, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yurgita R Varaeva, MD, MRes (+79253841894, varaeva@ion.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of pro-inflammatory macrophages activation (time frame: Twice: Baseline, treatment week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.