A prospective randomized study comparing the effects of empagliflozin versus sitagliptin on cardiac fat and function in patients with type 2 diabetes

JRCT ID: jRCTs031180240

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 23/05/2017
• Target sample size: 44
• Study type: Interventional

Intervention(s)

Group A: Empagliflozin treatment group
Group B: Sitagliptin treatment group

Outcome(s)

• Primary Outcome: Change and percent change of pericardial fat from baseline to week 12

Secondary Outcome

Secondary Outcome(s)Change and percent change of indexes below from baseline to week 12
1.Cardiomyocyte fat amount
2.Cardiac function
3.tissue fat amount (intracellular fat amount in hepatocyte, intra/extracellular fat amount in myocyte)
4.Insulin sensitivity (in myocardium, liver, muscle, adipose tissue)
5.Indexes in myocardial fatty acid metabolism (123I-BMIPP uptake (early/first-half image), 123I-BMIPP uptake (latter/second-half image), washout rate)
6.Percent of EGP suppression (suppression of hepatic glucose production rate)
7.Glucose infusion rate (GIR)
8.Glucose disappearance rate (Rd)
9.Indexes in insulin secretion (C-peptide, plasma insulin, HOMA-beta)
10.Index in insulin resistance (HOMA-IR)
11.Other indexes in insulin sensitivity (D2Glucose, glucose level, FFA)
12.Plasma glucagon
13.Indexes in energy metabolism (respiratory quotient, energy consumption, oxygen consumption, carbon dioxide emission)
14.Cardiac metabolism biomarkers (renin activity, aldosterone, aldosterone/renin activity ratio, BNP, H-FABP)
15.Oxidation stress biomarker (urinary 8OHdG)
16.Inflammatory biomarker (hsCRP)
17.Indexes in adipose tissue hormone (high-molecular weight adiponectin, leptin)
18.Metabolomics assay
19.Other blood tests (albumin, HbA1c, plasma glucose, TG, T-Cho, HDL, LDL, blood counts, Na, K, Cl, uric acid, Amy, serum creatinine, eGFR, FFA, plasma ketone body, AST, ALT, gamma-GTP, BUN, apolipoprotein)
20.Other urine tests (general urine test, microalbuminuria, urinary glucose, urinary ketone body, urinary Na, urinary K, urinary Cl, urinary creatinine, eGFR)
21.Body weight, blood pressure, heart rate, BMI, body composition (body fluid, bone mass, muscle mass, fat mass, body fat percentage, basal metabolism quantity)
22.Dietary intake and nutrient intakes (BDHQ BOX)
23.Medication adherence (medication adherence diary)
24.Frequency of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study:
1. Patients with type 2 diabetes mellitus whose HbA1c (NGS) is out of the glycemic control target recommended by the Treatment Guideline for Diabetes 2016-2017, which is 6.0% or higher and below 10.0%, even though patients have been treated with diet and exercise therapy, monotherapy with alpha-glucosidase inhibitor, sulfonylurea*, or glinide in addition to the diet and exercise therapy, or combination therapy with alpha-glucosidase inhibitor and sulfonylurea* or alpha-glucosidase inhibitor and glinide in addition to the diet and exercise therapy
2. Male and female patients aged of >= 20 years and < 75 years when giving their consent
3. Patients with BMI of 22 kg/m2 or greater
4. Patients who give their consent in a written form
*The dose of sulfonylurea is up to 2 mg of glimepiride, 1.25 mg of glibenclamide, or 40 mg of gliclazide, respectively.

Exclude criteria

Patients who meet any of the following criteria are excluded from the study:
1.Patients with type 1 diabetes mellitus or secondary diabetes
2.Patients with BMI of less than 22kg/m2
3.Patients with moderate to severe renal function impairment or at the terminal stage of renal failure (eGFR of less than 45mL/min/1.73m2)
4.Patients who had stroke, cerebral infarction within the last 12 weeks prior to consent acquisition
5.Patients with history of myocardial infarction or angina pectoris, or with current atrial fibrillation
6.Patient with LVEF of less than 30%
7.Patients with infectious disease
8.Patients with malignant tumor (patients who are not currently being treated for a malignant tumor without recurrence and those who can be expected not to have any recurrence during the study period can be included.)
9.Patients with connective tissue disease (patients with T2DM who have treated with prednisolone 5mg or less and show stable conditions can be considered to be participants of this study)
10.Patients with hepatocirrhosis
11.Patients with viral or autoimmune, or drug-induced hepatitis
12.Patients who are alcoholic or excessive drinkers
13.Patients are currently pregnant, possibly pregnant, breast-feeding, or planning to be pregnant during the study
14.Patients have a medical history of hypersensitivity to the study drugs
15.If the study drugs are contradicted to use
16.Patients with Hb below 12g/dl
17.Patients with other conditions that the investigator/researcher thinks inappropriate for the study

Related Information

• Primary Sponsor: Kumashiro Naoki
• Secondary Sponsor: Hirose Takahisa
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co., Ltd.,Nippon Boehringer Ingelheim Co., Ltd.
• Secondary ID(s): UMIN000026340