Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-08-01
2022-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metformin
Metformin 1.7-2.5mg per day during twelve weeks
Biguanide, DPP4 inhibitors, SGLT2 inhibitors
Oral antidiabetic treatment during twelve weeks
Metformina + IDDP-4
Metformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day
Biguanide, DPP4 inhibitors, SGLT2 inhibitors
Oral antidiabetic treatment during twelve weeks
Metformina + ISGLT-2
Metformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day
Biguanide, DPP4 inhibitors, SGLT2 inhibitors
Oral antidiabetic treatment during twelve weeks
Interventions
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Biguanide, DPP4 inhibitors, SGLT2 inhibitors
Oral antidiabetic treatment during twelve weeks
Eligibility Criteria
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Inclusion Criteria
* Patients with visceral fat quantification by BIA at baseline and week twelve
* Patients with body mass index \>25
* Patients can swallow tablets
Exclusion Criteria
* Glomerular filtration rate less than 30 mL/min
* Transaminemia greater than 2 times the upper reference value
* Pregnancy
* Malnutrition
18 Years
ALL
No
Sponsors
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Metabolic Research Unit
INDUSTRY
Responsible Party
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Alonso Alberto Castro Arguelles
Metabolic Research Unit
Locations
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Metabolic Research Unit
San Luis Potosà City, , Mexico
Countries
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References
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Lee DH, Park KS, Ahn S, Ku EJ, Jung KY, Kim YJ, Kim KM, Moon JH, Choi SH, Park KS, Jang HC, Lim S. Comparison of Abdominal Visceral Adipose Tissue Area Measured by Computed Tomography with That Estimated by Bioelectrical Impedance Analysis Method in Korean Subjects. Nutrients. 2015 Dec 16;7(12):10513-24. doi: 10.3390/nu7125548.
Park KS, Lee DH, Lee J, Kim YJ, Jung KY, Kim KM, Kwak SH, Choi SH, Park KS, Jang HC, Lim S. Comparison between two methods of bioelectrical impedance analyses for accuracy in measuring abdominal visceral fat area. J Diabetes Complications. 2016 Mar;30(2):343-9. doi: 10.1016/j.jdiacomp.2015.10.014. Epub 2015 Oct 24.
Golay A. Metformin and body weight. Int J Obes (Lond). 2008 Jan;32(1):61-72. doi: 10.1038/sj.ijo.0803695. Epub 2007 Jul 24.
Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x.
Bolinder J, Ljunggren O, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012 Mar;97(3):1020-31. doi: 10.1210/jc.2011-2260. Epub 2012 Jan 11.
Sugiyama S, Jinnouchi H, Kurinami N, Hieshima K, Yoshida A, Jinnouchi K, Nishimura H, Suzuki T, Miyamoto F, Kajiwara K, Jinnouchi T. Dapagliflozin Reduces Fat Mass without Affecting Muscle Mass in Type 2 Diabetes. J Atheroscler Thromb. 2018 Jun 1;25(6):467-476. doi: 10.5551/jat.40873. Epub 2017 Dec 8.
Schork A, Saynisch J, Vosseler A, Jaghutriz BA, Heyne N, Peter A, Haring HU, Stefan N, Fritsche A, Artunc F. Effect of SGLT2 inhibitors on body composition, fluid status and renin-angiotensin-aldosterone system in type 2 diabetes: a prospective study using bioimpedance spectroscopy. Cardiovasc Diabetol. 2019 Apr 5;18(1):46. doi: 10.1186/s12933-019-0852-y.
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
Other Identifiers
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protocol1
Identifier Type: -
Identifier Source: org_study_id
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