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Status unknownNCT05032001Updated Sep 9, 2021

ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

An interventional study of Biguanide, DPP4 inhibitors, SGLT2 inhibitors in Abdominal Obesity and Type 2 Diabetes, sponsored by Metabolic Research Unit. Status unknown at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-09.

Sponsored by Metabolic Research Unit · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Abdominal Obesity
  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

This is the only study on the registry with Metabolic Research Unit as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Metformin

    Metformin 1.7-2.5mg per day during twelve weeks

    Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors

  • Experimental
    Metformina + IDDP-4

    Metformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day

    Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors

  • Experimental
    Metformina + ISGLT-2

    Metformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day

    Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors

Interventions

  • DrugBiguanide, DPP4 inhibitors, SGLT2 inhibitors

    Oral antidiabetic treatment during twelve weeks

06

What researchers measure

Primary outcomes

  1. Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve

    Bioimpedance is a confident method to measured visceral fat

    Time frame: Baseline and week twelve

Other outcomes

  1. Change from baseline in A1c level at week twelve

    Glycated hemoglobin percentage is the most reliable method to explain glycemic control in type 2 diabetes patients

    Time frame: Baseline and week twelve

07

Study locations

1 site
  • Metabolic Research Unit
    San Luis Potosi, 78218, Mexico
08

References and documents

Publications

  • 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. PubMed 26694460 ↗
  • 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. PubMed 26620129 ↗
  • 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. PubMed 17653063 ↗
  • 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. PubMed 17300595 ↗
  • 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. PubMed 22238392 ↗
  • 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. PubMed 29225209 ↗
  • 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. PubMed 30953516 ↗
  • 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. PubMed 26092476 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05032001
Lead sponsor
Metabolic Research Unit
Responsible party
Alonso Alberto Castro Arguelles (Metabolic Research Unit, Metabolic Research Unit) — Principal investigator
First posted
Sep 2, 2021
Start date
Aug 1, 2021
Primary completion
Aug 1, 2022 (estimated)
Completion
Aug 1, 2022 (estimated)
Last update
Sep 9, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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