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

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Dapagliflozin; Metformin

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