Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial.
Adult
Benzhydryl Compounds
/ administration & dosage
Clinical Trials, Phase IV as Topic
Diabetes Mellitus, Type 2
/ complications
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Therapy, Combination
/ methods
Female
Glucosides
/ administration & dosage
Humans
Male
Metformin
/ administration & dosage
Mexico
Middle Aged
Obesity, Morbid
/ drug therapy
Prediabetic State
/ complications
Randomized Controlled Trials as Topic
Severity of Illness Index
Treatment Outcome
Waist Circumference
/ drug effects
Weight Loss
/ drug effects
Young Adult
Metformin
Morbid
Obesity
Prediabetes
Sodium-glucose transporter 2 inhibitors
Type 2 Diabetes Mellitus
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
14 Feb 2020
14 Feb 2020
Historique:
received:
05
08
2019
accepted:
30
01
2020
entrez:
16
2
2020
pubmed:
16
2
2020
medline:
15
12
2020
Statut:
epublish
Résumé
Mexico has one of the highest prevalence rates of obesity worldwide. New pharmacological strategies that focus on people with class III obesity are required. Metformin and dapagliflozin are two drugs approved for the treatment of diabetes. Beyond its effects on glucose, metformin has been suggested by some studies to result in weight loss. Therapy with dapagliflozin is associated with a mild but sustained weight loss in patients with diabetes. The primary outcome of the study is to determine if the combined treatment with dapagliflozin and metformin is more effective than monotherapy with metformin for weight loss in patients with class III obesity and prediabetes or diabetes who are awaiting bariatric surgery (including those patients who do have surgery). We also aimed to assess the effect of this combined treatment on waist circumference, triglycerides, blood pressure, and inflammatory cytokines. This randomized phase IV clinical trial will include patients with diabetes or prediabetes who are between the ages of 18 and 60 years and exhibit grade III obesity (defined as body mass index ≥ 40 kg/m Forty-six percent of the patients in our Obesity Clinic have been diagnosed with prediabetes (32%) or diabetes (14%). The use of dapagliflozin in this population could improve weight loss and other cardiovascular factors. This effect could be translated into less time before undergoing bariatric surgery and better control of associated comorbidities. Clinicaltrials.gov, ID: NCT03968224. Retrospectively registered on May 29, 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Mexico has one of the highest prevalence rates of obesity worldwide. New pharmacological strategies that focus on people with class III obesity are required. Metformin and dapagliflozin are two drugs approved for the treatment of diabetes. Beyond its effects on glucose, metformin has been suggested by some studies to result in weight loss. Therapy with dapagliflozin is associated with a mild but sustained weight loss in patients with diabetes. The primary outcome of the study is to determine if the combined treatment with dapagliflozin and metformin is more effective than monotherapy with metformin for weight loss in patients with class III obesity and prediabetes or diabetes who are awaiting bariatric surgery (including those patients who do have surgery). We also aimed to assess the effect of this combined treatment on waist circumference, triglycerides, blood pressure, and inflammatory cytokines.
METHODS
METHODS
This randomized phase IV clinical trial will include patients with diabetes or prediabetes who are between the ages of 18 and 60 years and exhibit grade III obesity (defined as body mass index ≥ 40 kg/m
DISCUSSION
CONCLUSIONS
Forty-six percent of the patients in our Obesity Clinic have been diagnosed with prediabetes (32%) or diabetes (14%). The use of dapagliflozin in this population could improve weight loss and other cardiovascular factors. This effect could be translated into less time before undergoing bariatric surgery and better control of associated comorbidities.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov, ID: NCT03968224. Retrospectively registered on May 29, 2019.
Identifiants
pubmed: 32059692
doi: 10.1186/s13063-020-4121-x
pii: 10.1186/s13063-020-4121-x
pmc: PMC7023779
doi:
Substances chimiques
Benzhydryl Compounds
0
Glucosides
0
dapagliflozin
1ULL0QJ8UC
Metformin
9100L32L2N
Banques de données
ClinicalTrials.gov
['NCT03968224']
Types de publication
Clinical Trial Protocol
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
186Subventions
Organisme : Instituto Mexicano del Seguro Social
ID : FIS/IMSS/PROT/G17-2/1752
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