ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

NCT ID: NCT05032001

Last Updated: 2021-09-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-08-01

Brief Summary

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Weight control is an essential part of treatment for type 2 diabetes (T2D) patients. Weight loss is associated with decreased haemoglobin A1c (A1c) levels. In particular, visceral fat is accompanied by more alterations in glucose and lipid metabolism. Quantification of visceral fat with bioimpedance (BIA) is closely related to measurement with computed axial tomography. Different available oral antidiabetics cause weight loss and total body fat (biguanides, DPP-4 inhibitors and SGLT-2 inhibitors), but it has only been shown that SLGT2 inhibitors decrease visceral fat. Therefore, the aim of this study is to determine whether there is a difference in the amount of visceral fat measured with BIA in T2D patients between three oral antidiabetic regimens after twelve weeks of treatment, to compare the effect on visceral fat between metformin, DPP4 inhibitors and SGLT2 inhibitors.

Detailed Description

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Conditions

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Abdominal Obesity Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

Metformin 1.7-2.5mg per day during twelve weeks

Group Type EXPERIMENTAL

Biguanide, DPP4 inhibitors, SGLT2 inhibitors

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Biguanide, DPP4 inhibitors, SGLT2 inhibitors

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Biguanide, DPP4 inhibitors, SGLT2 inhibitors

Intervention Type DRUG

Oral antidiabetic treatment during twelve weeks

Interventions

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Biguanide, DPP4 inhibitors, SGLT2 inhibitors

Oral antidiabetic treatment during twelve weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients +18 years
* Patients with visceral fat quantification by BIA at baseline and week twelve
* Patients with body mass index \>25
* Patients can swallow tablets

Exclusion Criteria

* Patients treated with other oral antidiabetic agents or insulin
* Glomerular filtration rate less than 30 mL/min
* Transaminemia greater than 2 times the upper reference value
* Pregnancy
* Malnutrition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Metabolic Research Unit

INDUSTRY

Sponsor Role lead

Responsible Party

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Alonso Alberto Castro Arguelles

Metabolic Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Metabolic Research Unit

San Luis Potosí City, , Mexico

Site Status

Countries

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Mexico

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.

Reference Type BACKGROUND
PMID: 26694460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26620129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17653063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17300595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22238392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29225209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30953516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26092476 (View on PubMed)

Other Identifiers

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protocol1

Identifier Type: -

Identifier Source: org_study_id

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