ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

Type 2 Diabetes Clinical Trial

Official title:

ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05032001
• Other study ID #: protocol1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2021
• Source: Metabolic Research Unit
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Obesity
• Diabetes Mellitus, Type 2
• Obesity, Abdominal
• Type 2 Diabetes

Intervention

Drug:
• Biguanide, DPP4 inhibitors, SGLT2 inhibitors
Oral antidiabetic treatment during twelve weeks

Locations

Country	Name	City	State
Mexico	Metabolic Research Unit	San Luis Potosi

Sponsors (1)

Lead Sponsor	Collaborator
Metabolic Research Unit

Country where clinical trial is conducted

Mexico, 

References & Publications (8)

Bolinder J, Ljunggren Ö, 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. — View Citation

Golay A. Metformin and body weight. Int J Obes (Lond). 2008 Jan;32(1):61-72. Epub 2007 Jul 24. Review. — View 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. — View 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. — View 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. — View Citation

Schork A, Saynisch J, Vosseler A, Jaghutriz BA, Heyne N, Peter A, Häring 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Baseline and week twelve
Primary	Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve	Bioimpedance is a confident method to measured visceral fat	Baseline and week twelve