Effect of green tea and metformin on excess of sugar on the blood of obese individuals with pre-diabetes

Not Applicable

• Conditions: Obesity, hyperglycemia; C18.654.726.500; R73.9

• Registration Number: RBR-4bdwxs
• Lead Sponsor: CAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Obese individuals (fat> 30%) with pre-diabetes, women, aged 20-60 years.

Exclusion Criteria

Volunteers with thyroid disorders; diabetes; renal and hepatic diseases; pregnant women; nursing; in hormone replacement; under treatment for weight control; those who are not available to participate in all stages of the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changing the parameters ??of glycemic control assessed by fasting plasma glucose through enzymatic colorimetric method and glycated hemoglobin by turbidity method, based on the statement of change in pre- and post- intervention measurements to identify them as risk factors for type 2 diabetes mellitus in this population

Secondary Outcome Measures

Name	Time	Method
Changes in other risk factors for type 2 diabetes: the body composition assessed by densitometry (DEXA) from the realization of a range of at least 2% in pre and post intervention measurements; lipid profile checked the levels of triglycerides, total cholesterol and fractions through enzymatic methods and enzymatic colorimetric from the realization of a range of at least 1% in the pre and post intervention measurements; inflammatory status evaluated by the change in tumor necrosis factor levels, interleukin 6, interleukin 10, leptin, insulin and adiponectin levels being determined by means of a high sensitivity panel to humans (Milliplex, Millipore Corp., Missouri, USA) using Luminex xMAP technology (Multiple Analyte Profiling) which shall be considered an outcome occurred if there is any negative change; antioxidant activities verified by analyzing the antioxidant capacity of plasma and activity of antioxidant enzymes, which will be considered as an outcome occurred if there is any negative change