Effect of Dapagliflozin/Metformin XR vs Monotherapies on Anthropometric Indicators in Obesity

NCT ID: NCT03710460

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2023-12-30

Brief Summary

Obesity has increased to alarming levels in the world. Currently it is estimated that it occurs in a third of the world's population and it is expected that by 2030, 20% of the world's adult population will suffer from obesity and 38% will be overweight, and it is important to highlight that Mexico is among the first in obesity in adults and children.

Obesity leads to the development of diseases such as diabetes mellitus type 2, dyslipidemias, metabolic syndrome, heart problems, among others.

The treatment for obesity in the first instance are changes in lifestyle, changes in diet and exercise that have shown, in most patients, have little long-term adherence. There are also drugs that promote weight loss by modifying the appetite or absorption of macronutrients.

Dapagliflozin plus metformin XR is a medicine composed with an oral antidiabetic of the group of inhibitors of SGLT2 that has shown to have significant side effects in the weight reduction and visceral adiposity in people with obesity and in patients with diabetes mellitus type 2, it is also composed with metformin which also has effects on weight loss in people with and without type 2 diabetes mellitus.

For these reasons, evaluating this compound drug in people with obesity could provide high impact information as a complement for the treatment of this condition when compared to the effects produced by monotherapies.

Detailed Description

A double-blind, randomized clinical trial of three pharmacological groups in 33 patients with a diagnosis of grade 1 obesity in accordance with the World Health Organization (WHO) without treatment.

They will be assigned randomly three groups of 11 patients, each one will receive 10 mg of dapaglizflozin (Forxiga, Astra Zeneca), 1000 mg of metformin XR or 10/1000 mg of dapagliflozin plus metformin XR, one time per day before having break-fast during 12 weeks.

The body weight, body mass index (BMI), adiposity %, visceral adiposity, fat mass, lean mass, waist circunference,waist-hip index, arterial pressure, and laboratory parameters as a glucose, triglicerides, cholesterol, High density lipoprotein (c-HDL), low density lipoprotein (c-LDL), uric acid, creatinin, C reactive protein, adiponectin and interleukin 10, leptin and TNF-∝will be measures.

This protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Kruskal-Wallis Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dapagliflozin

Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

10 mg, one per day before breakfast during 12 weeks.

Dapagliflozin plus metformin XR

Dapagliflozin plus metformin XR capsules, 10/1000 mg, one per day before breakfast during 12 weeks.

Group Type: EXPERIMENTAL

Dapagliflozin plus Metformin XR

Intervention Type: DRUG

10/1000 mg, one per day before breakfast during 12 weeks.

Metformin XR

Metformin XR capsules, 1000 mg, one per day before breakfast during 12 weeks.

Group Type: EXPERIMENTAL

Metformin XR

Intervention Type: DRUG

1000 mg, one per day before breakfast during 12 weeks.

Interventions

Dapagliflozin

10 mg, one per day before breakfast during 12 weeks.

Intervention Type: DRUG

Dapagliflozin plus Metformin XR

10/1000 mg, one per day before breakfast during 12 weeks.

Intervention Type: DRUG

Metformin XR

1000 mg, one per day before breakfast during 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Forxiga; XigDuo

Eligibility Criteria

Inclusion Criteria

• Diagnosed grade 1 obesity according to the WHO criteria:
• -Body Mass Index (BMI) between 30 to 34.9 kg/m²
• No pharmacological treatment for obesity
• Stable weight during the last 3 months

Exclusion Criteria

• Pregnancy or breast-feeding
• History of kidney or liver disease
• Drugs or supplements consumption with proven properties that modify the behavior of obesity
• Total cholesterol >240 mg/dL
• Triglycerides >500mg/dL
• Glucose ≥126 mg/dL or HbA1C ≥6.5%.
• Patients who smoke daily for the last 6 months
• Hypersensitivity to dapagliflozin or metformin XR

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Karina Griselda Pérez Rubio

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel Gonzalez Ortiz, MD MSc Phd

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Manuel Gonzalez Ortiz, MD MSc Phd

Role: CONTACT

uiec@prodigy.net.mx

+523310585200 ext. 34212

Karina G Perez Rubio, PhD

Role: CONTACT

karia2410@hotmail.com

+523310585200 ext. 34212

Facility Contacts

Manuel Gonzalez, PhD

Role: primary

uiec@prodigy.net.mx

+52-10-58-52-00 ext. 34212

Other Identifiers

Dapa-MetforminXR in Obesity

Identifier Type: -

Identifier Source: org_study_id