What is the clinical evidence from this study?

Study design: Other. Population: Non-obese type 2 diabetes with visceral obesity (n=9). Intervention: Ipragliflozin. Primary outcome: Change in epicardial fat volume at 12 weeks (p=0.008).

June 14, 2017Open Access

Ipragliflozin Reduces Epicardial Fat Accumulation in Non-Obese Type 2 Diabetic Patients with Visceral Obesity: A Pilot Study

Key Result

Ipragliflozin significantly reduced epicardial fat volume from a median of 102 cm3 to 89 cm3 over 12 weeks in non-obese type 2 diabetic patients with visceral adiposity.

Structured PICO

Does ipragliflozin reduce epicardial fat volume in non-obese type 2 diabetic patients with visceral obesity?

Population

9 Japanese adults with type 2 diabetes, non-obese (BMI <25.0 kg/m2) but with visceral obesity (visceral fat area ≥100 cm2) and HbA1c 6.5-9.0%. Mean age 66 ± 8 years, 33% female. Excluded: prior SGLT2 inhibitor use, insulin treatment, active infection, malignancy, congestive heart failure, severe liver/renal diseases, severe diabetic retinopathy, recent ACS or stroke.

Intervention

Ipragliflozin 50 mg oral once daily after breakfast for 12 weeks.

Outcome

Change in epicardial fat volume (EFV) at 12 weeks measured by magnetic resonance imaging.surrogate

A 12-week intervention with ipragliflozin significantly reduced epicardial fat volume and body weight in non-obese type 2 diabetic patients with visceral adiposity, suggesting potential cardiometabolic benefits beyond glycemic control.

Main Result

Absolute Event Rate: 89% vs 102%

p-value: p=0.008

Limitations

Single-arm study design
Small sample size
No information on diet and exercise
Ethnically homogenous population (Japanese)

Abstract

Abstract Introduction Epicardial fat (EF) was reported to be independently associated with cardiovascular disease regardless of obesity. We have previously reported that a sodium-glucose co-transporter-2 (SGLT2) inhibitor, luseogliflozin, reduces the EF volume (EFV) in parallel with the reduction of body weight in obese patients (BMI ≥25 kg/m 2 ) with type 2 diabetes. However, it is unknown whether SGLT2 inhibitors could reduce EFV in non-obese patients (BMI <25 kg/m 2 ) with type 2 diabetes. Therefore, we evaluated the effect of SGLT2 inhibitors on the EFV in non-obese type 2 diabetic patients with visceral obesity in this pilot study. Methods Nine of type 2 diabetic patients (mean age 66 ± 8 years; 33% female) with HbA 1c 6.5–9.0%, body mass index (BMI, kg/m 2 ) <25.0, and visceral fat area (VFA, cm 2 ) ≥100 were enrolled. Participants were administered ipragliflozin 50 mg daily. EFV median (interquartile range), cm 3 was measured by magnetic resonance imaging. Primary endpoint was the change in EFV at 12 weeks. VFA and liver attenuation index (LAI), skeletal muscle index (SMI), and body fat (%) were also assessed at baseline and at 12 weeks. Results The EFV was significantly reduced from 102 (79–126) cm 3 to 89 (66–109) cm 3 by ipraglifrozin ( p = 0.008). The body weight, BMI, HbA 1c , fasting plasma glucose, insulin, homeostasis model assessment-insulin resistance, triglycerides, leptin, body fat, android, gynoid, and VFA were significantly reduced and high-density lipoprotein cholesterol was significantly increased by ipraglifrozin at 12 weeks, whereas SFA and LAI were unchanged. The change in EFV was significantly correlated with the change in BMI. Conclusions A12-week intervention of ipragliflozin reduced the EFV in non-obese type 2 diabetic patients with visceral adiposity. Clinical Trial Registration UMIN Clinical Trial Registry: UMIN000019071. Funding Astellas Pharma Inc. and the Grants-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan.

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