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

Not Applicable

Completed

• Conditions: Obesity; Overweight; Berberine

• Registration Number: NCT06703086
• Lead Sponsor: National Polytechnic Institute, Mexico

Brief Summary

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.

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 Timeline

• Study Start: 2019-01-05
• Primary Completion: 2019-08-15
• Study Completion: 2020-02-15
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity	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
To determine the effects of Berberine on the gene modulation of IL-1β in peripheral blood of patients with exogenous obesity	"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
To determine the effects of Berberine on the gene modulation of TNFα in peripheral blood of patients with exogenous obesity	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 Outcome Measures

Name	Time	Method
Weight	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.
Body mass index	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.
Percentage of body fat	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).
Percentage of visceral fat	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).
Height	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.