Effect of Dapagliflozin/Metformin XR vs Monotherapies on Anthropometric Indicators in Obesity
Primary Purpose
Obesity
Status
Recruiting
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Dapagliflozin
Dapagliflozin plus Metformin XR
Metformin XR
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Dapagliflozin, Metformin XR, Visceral adiposity
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
Sites / Locations
- Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de GuadalajaraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dapagliflozin
Dapagliflozin plus metformin XR
Metformin XR
Arm Description
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin plus metformin XR capsules, 10/1000 mg, one per day before breakfast during 12 weeks.
Metformin XR capsules, 1000 mg, one per day before breakfast during 12 weeks.
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
Waist circumference
Waist circumference will be evaluated with the method proposed by ISAK.
Waist-hip ratio
The waist-hip ratio will be calculated as waist measurement divided by hip measurement
Secondary Outcome Measures
Interleukin 10 levels IL-10
Interleukin levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total interleukin 10 level at week 12
Adiponectin levels.
adiponectin levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorben Assayed (ELISA) the entered values reflect the total adiponectin levels at week 12
C-reactive protein levels
C-reactive protein levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total C-reactive protein levels levels at week 12
Leptin levels
Leptin levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total leptin levels levels at week 12
TNF-α levels
Tumor necrosis factor alpha (TNF-α) levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total TNF-αl levels levels at week 12
Total cholesterol
Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
HDL cholesterol
High density lipoprotein cholesterol (HDL-C)
LDL cholesterol
Low density lipoprotein cholesterol (LDL-C)
Triglycerides levels
Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
Fasting glucose levels
The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12.
Creatinine levels
Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Uric acid levels
Uric acid levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Systolic blood pressure
blood pressure will be measured at baseline week 4, week 8 and week 12 with a digital sphygmomanometer. Values will be expressed in millimeters of mercury (mmHg).
Diastolic blood pressure
blood pressure will be measured at baseline week 4, week 8 and week 12 with a digital sphygmomanometer. Values will be expressed in millimeters of mercury (mmHg).
Full Information
NCT ID
NCT03710460
First Posted
October 4, 2018
Last Updated
May 22, 2023
Sponsor
University of Guadalajara
1. Study Identification
Unique Protocol Identification Number
NCT03710460
Brief Title
Effect of Dapagliflozin/Metformin XR vs Monotherapies on Anthropometric Indicators in Obesity
Official Title
Effect of the Administration of the Combination of Dapagliflozin Plus Metformin XR Versus Monotherapies on Anthropometric Indicators in Patients With Grade 1 Obesity.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Dapagliflozin, Metformin XR, Visceral adiposity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Arm Title
Dapagliflozin plus metformin XR
Arm Type
Experimental
Arm Description
Dapagliflozin plus metformin XR capsules, 10/1000 mg, one per day before breakfast during 12 weeks.
Arm Title
Metformin XR
Arm Type
Experimental
Arm Description
Metformin XR capsules, 1000 mg, one per day before breakfast during 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
Forxiga
Intervention Description
10 mg, one per day before breakfast during 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin plus Metformin XR
Other Intervention Name(s)
XigDuo
Intervention Description
10/1000 mg, one per day before breakfast during 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Metformin XR
Intervention Description
1000 mg, one per day before breakfast during 12 weeks.
Primary Outcome Measure Information:
Title
Body Weight
Description
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
Time Frame
Baseline to week 12
Title
Body Mass Index
Description
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
Time Frame
Baseline to week 12
Title
Adiposity percentage
Description
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
Time Frame
Baseline, week 4, week 8 and week 12
Title
Visceral adiposity
Description
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
Time Frame
Baseline to week 12
Title
Lean mass
Description
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
Time Frame
Baseline to week 12
Title
Fat mass
Description
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
Time Frame
Baseline to week 12
Title
Waist circumference
Description
Waist circumference will be evaluated with the method proposed by ISAK.
Time Frame
Baseline to week 12
Title
Waist-hip ratio
Description
The waist-hip ratio will be calculated as waist measurement divided by hip measurement
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
Interleukin 10 levels IL-10
Description
Interleukin levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total interleukin 10 level at week 12
Time Frame
Baseline and week 12
Title
Adiponectin levels.
Description
adiponectin levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorben Assayed (ELISA) the entered values reflect the total adiponectin levels at week 12
Time Frame
Baseline and week 12
Title
C-reactive protein levels
Description
C-reactive protein levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total C-reactive protein levels levels at week 12
Time Frame
Baseline and week 12
Title
Leptin levels
Description
Leptin levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total leptin levels levels at week 12
Time Frame
Baseline and week 12
Title
TNF-α levels
Description
Tumor necrosis factor alpha (TNF-α) levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total TNF-αl levels levels at week 12
Time Frame
Baseline and week 12
Title
Total cholesterol
Description
Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
Time Frame
Baseline to Week 12
Title
HDL cholesterol
Description
High density lipoprotein cholesterol (HDL-C)
Time Frame
Total high density lipoprotein cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the high density lipoprotein cholesterol level at week 12
Title
LDL cholesterol
Description
Low density lipoprotein cholesterol (LDL-C)
Time Frame
Total low density lipoprotein cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the low density lipoprotein cholesterol level at week 12
Title
Triglycerides levels
Description
Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
Time Frame
Baseline to Week 12
Title
Fasting glucose levels
Description
The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12.
Time Frame
Baseline to Week 12
Title
Creatinine levels
Description
Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Time Frame
Baseline to Week 12
Title
Uric acid levels
Description
Uric acid levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Time Frame
Baseline to Week 12
Title
Systolic blood pressure
Description
blood pressure will be measured at baseline week 4, week 8 and week 12 with a digital sphygmomanometer. Values will be expressed in millimeters of mercury (mmHg).
Time Frame
Baseline, week 4, week 8 and week 12
Title
Diastolic blood pressure
Description
blood pressure will be measured at baseline week 4, week 8 and week 12 with a digital sphygmomanometer. Values will be expressed in millimeters of mercury (mmHg).
Time Frame
Baseline, week 4, week 8 and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Gonzalez Ortiz, MD MSc Phd
Phone
+523310585200
Ext
34212
Email
uiec@prodigy.net.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Karina G Perez Rubio, PhD
Phone
+523310585200
Ext
34212
Email
karia2410@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Gonzalez Ortiz, MD MSc Phd
Organizational Affiliation
University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Gonzalez, PhD
Phone
+52-10-58-52-00
Ext
34212
Email
uiec@prodigy.net.mx
12. IPD Sharing Statement
Learn more about this trial
Effect of Dapagliflozin/Metformin XR vs Monotherapies on Anthropometric Indicators in Obesity
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