NCT03710460

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

Effect of the Administration of the Combination of Dapagliflozin Plus Metformin XR Versus Monotherapies on Anthropometric Indicators in Patients With Grade 1 Obesity.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: University of Guadalajara · Academic / Other
• Sex: All
• Age: 31 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Dapagliflozin	10 mg, one per day before breakfast during 12 weeks.
DRUG	Dapagliflozin plus Metformin XR	10/1000 mg, one per day before breakfast during 12 weeks.
DRUG	Metformin XR	1000 mg, one per day before breakfast during 12 weeks.

Timeline

• Start date: 2019-07-30
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2018-10-18
• Last updated: 2023-05-23

Locations

1 site across 1 country: Mexico