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ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

Primary Purpose

Abdominal Obesity, Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Biguanide, DPP4 inhibitors, SGLT2 inhibitors
Sponsored by
Metabolic Research Unit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Metabolic Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Metformin

Metformina + IDDP-4

Metformina + ISGLT-2

Arm Description

Metformin 1.7-2.5mg per day during twelve weeks

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

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

Outcomes

Primary Outcome Measures

Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve
Bioimpedance is a confident method to measured visceral fat

Secondary Outcome Measures

Full Information

First Posted
August 21, 2021
Last Updated
September 1, 2021
Sponsor
Metabolic Research Unit
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1. Study Identification

Unique Protocol Identification Number
NCT05032001
Brief Title
ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT
Official Title
ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Metabolic Research Unit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin 1.7-2.5mg per day during twelve weeks
Arm Title
Metformina + IDDP-4
Arm Type
Experimental
Arm Description
Metformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day
Arm Title
Metformina + ISGLT-2
Arm Type
Experimental
Arm Description
Metformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day
Intervention Type
Drug
Intervention Name(s)
Biguanide, DPP4 inhibitors, SGLT2 inhibitors
Intervention Description
Oral antidiabetic treatment during twelve weeks
Primary Outcome Measure Information:
Title
Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve
Description
Bioimpedance is a confident method to measured visceral fat
Time Frame
Baseline and week twelve
Other Pre-specified Outcome Measures:
Title
Change from baseline in A1c level at week twelve
Description
Glycated hemoglobin percentage is the most reliable method to explain glycemic control in type 2 diabetes patients
Time Frame
Baseline and week twelve

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Metabolic Research Unit
City
San Luis Potosi
ZIP/Postal Code
78218
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26694460
Citation
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.
Results Reference
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PubMed Identifier
26620129
Citation
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.
Results Reference
background
PubMed Identifier
17653063
Citation
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.
Results Reference
background
PubMed Identifier
17300595
Citation
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.
Results Reference
background
PubMed Identifier
22238392
Citation
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.
Results Reference
background
PubMed Identifier
29225209
Citation
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.
Results Reference
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PubMed Identifier
30953516
Citation
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.
Results Reference
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PubMed Identifier
26092476
Citation
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.
Results Reference
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ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

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