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.
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 obesity
Started Jul 2019
Longer than P75 for phase_4 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2018
CompletedFirst Posted
Study publicly available on registry
October 18, 2018
CompletedStudy Start
First participant enrolled
July 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedMay 23, 2023
June 1, 2022
4.4 years
October 4, 2018
May 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Body Weight
The body weight will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12
Baseline to week 12
Body Mass Index
Body Mas Index will be calculated at baseline to week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12
Baseline to week 12
Adiposity percentage
The adiposity percentage will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the adiposity percentage at week 12
Baseline, week 4, week 8 and week 12
Visceral adiposity
Visceral adiposity will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the visceral adiposity in square meter at week 12
Baseline to week 12
Lean mass
The lean mass will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the lean mass at week 12
Baseline to week 12
Fat mass
The fat mass will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the fat mass at week 12
Baseline to week 12
Waist circumference
Waist circumference will be evaluated with the method proposed by ISAK.
Baseline to week 12
Waist-hip ratio
The waist-hip ratio will be calculated as waist measurement divided by hip measurement
Baseline to week 12
Secondary Outcomes (14)
Interleukin 10 levels IL-10
Baseline and week 12
Adiponectin levels.
Baseline and week 12
C-reactive protein levels
Baseline and week 12
Leptin levels
Baseline and week 12
TNF-α levels
Baseline and week 12
- +9 more secondary outcomes
Study Arms (3)
Dapagliflozin
EXPERIMENTALDapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin plus metformin XR
EXPERIMENTALDapagliflozin plus metformin XR capsules, 10/1000 mg, one per day before breakfast during 12 weeks.
Metformin XR
EXPERIMENTALMetformin XR capsules, 1000 mg, one per day before breakfast during 12 weeks.
Interventions
10 mg, one per day before breakfast during 12 weeks.
10/1000 mg, one per day before breakfast during 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manuel Gonzalez Ortiz, MD MSc Phd
University of Guadalajara
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 4, 2018
First Posted
October 18, 2018
Study Start
July 30, 2019
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
May 23, 2023
Record last verified: 2022-06