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

November 22, 2024 updated by: Modesto Gómez López, National Polytechnic Institute, Mexico
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutritional plan only
Nutritional plan according to your caloric requirements for lifestyle
Behavioral: nutritional plan
nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
Active Comparator: Nutritional plan and moderate aerobic exercise
nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week
Behavioral: nutritional plan
nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
Behavioral: controlled moderate aerobic exercise
controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.
Experimental: Berberine, nutritional plan and moderate exercise
nutritional plan, moderate aerobic exercise and the phytopharmaceutical Berberine 500 mg every 8 hours for 3 months.
Behavioral: nutritional plan
nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
Behavioral: controlled moderate aerobic exercise
controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.
Dietary supplement: Berberine Hydrochloride group
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.
No Intervention: No intervention
patients who met the inclusion criteria but did not receive treatment or intervention, only somatometry and blood samples were taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 3 months
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
"From enrollment to the end of treatment at 3 months
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
From enrollment to the end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
the first 3 months every 2 weeks, then every month thereafter until 6 months are completed
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.
Body mass index will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.
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).
It will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.
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).
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.
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.
Height will be measured every two weeks for 3 months and then every month for 3 months to complete the 6 months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Polytechnic Institute, Mexico

Investigators

  • Study Director: Nadia-Mabel PV PhD Nadia Mabel Pérez Vielma, PhD, 044-5520583053

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2019

Primary Completion (Actual)

August 15, 2019

Study Completion (Actual)

February 15, 2020

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.ESM.CE-01/7-12-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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