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Completed

NCT Number: NCT06703086

Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine

The patients will be invited to participate in a research study aimed at determining the Gene Modulation of NLRP3, IL-1β and TNFα in peripheral blood of patients with exogenous obesity treated with berberine.

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Key information

Conditions

Obesity Berberine Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The study will take 6 months in total, in this study will participate patients with exogenous obesity, which is defined as an abnormal accumulation of fat that can be detrimental to health. After the evaluation it will be determined if you meet the section criteria to be able to participate in the study. The patients will be randomly assigned to a group which may be:

Group I. The investigator will give a nutritional plan according to your caloric requirements for lifestyle change and the patients will be scheduled biweekly for 3 months to assess your weight, height, body mass index and percentages of fat or muscle.

Group 2. The investigator will be given a nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.

The patient will be given a lifestyle change plan in accordance with their nutritional requirements.

Group 3. The investigator will give a nutritional plan, moderate aerobic exercise with a goal of 10,000 steps or 150 min per week; and the phytopharmaceutical Berberine will take 3 tablets every 8 hours for 3 months.

Biweekly sessions will be carried out for 3 months, then monthly for 6 months; blood samples will be taken at the beginning of the study, that is, after the informed consent, at 3 and 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Patients with BMI ≥ 30kg/m2
  • With risk factors for type 2 diabetes (history of diabetic parents or siblings, sedentary habits)
  • Fasting blood glucose ≤ 126 mg/dL or glycosylated hemoglobin < 6.5%
  • Controlled arterial hypertension
  • >18 years of age
  • Accept and sign the informed consent

Exclusion criteria

  • • Pregnancy patients
  • Diabetics patients
  • Presenting any serious adverse effect
  • Patients who decide to withdraw from the protocol

Treatment and study plan

Berberine Hydrochloride group

Dietary Supplement

The patient will be given a nutritional plan, moderate aerobic exercise with a goal of 10,000 steps or 150 min per week; and the phytopharmaceutical Berberine will be taken 3 tablets ( 500 mg) every 8 hours for 3 months.

nutritional plan

Behavioral

nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months

controlled moderate aerobic exercise

Behavioral

controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.

Primary outcomes

  1. To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity

    Time frame: From enrollment to the end of treatment at 3 months

    Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR

  2. To determine the effects of Berberine on the gene modulation of IL-1β in peripheral blood of patients with exogenous obesity

    Time frame: "From enrollment to the end of treatment at 3 months

    Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR

  3. To determine the effects of Berberine on the gene modulation of TNFα in peripheral blood of patients with exogenous obesity

    Time frame: From enrollment to the end of treatment at 3 months

    Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR in peripheral blood

Secondary outcomes

  1. Weight

    Time frame: the first 3 months every 2 weeks, then every month thereafter until 6 months are completed

    The weight will be taken on a scale calibrated in kilograms.

  2. Body mass index

    Time frame: Body mass index will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.

    The body mass index was calculated by dividing the weight in kilograms by the square of the height in meters.

  3. Percentage of body fat

    Time frame: It will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.

    Instrument: Body composition analyzer (InBody770).

    • The measurement was expressed in Kg, with a precision of 0.1 kg. It was determined with the body analyzer, programmed with the required parameters (age, sex, height, among others).

  4. Percentage of visceral fat

    Time frame: To be taken every two weeks for the first 3 months and then every month for three months to complete 6 months of follow-up.

    • Instrument: Body composition analyzer (InBody770).
    • The measurement was expressed in Kg, with a precision of 0.1 kg. It was determined with the body analyzer, programmed with the required parameters (age, sex, height, among others).

  5. Height

    Time frame: Height will be measured every two weeks for 3 months and then every month for 3 months to complete the 6 months follow-up.

    It was defined as the distance between the vertex and the support plane.

    • Instrument: Stadiometer (Seca mod. 208).
    • The measurement was expressed in cm with a precision of 1 mm.

Sponsors and collaborators

Lead sponsor

National Polytechnic Institute, Mexico

Other

Registry information

Acronym: Obesity-Berber

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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